{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,13]],"date-time":"2026-11-13T12:35:11Z","timestamp":1794573311304,"version":"4.9.1"},"reference-count":509,"publisher":"BMJ","license":[{"start":{"date-parts":[[2025,4,28]],"date-time":"2025-04-28T00:00:00Z","timestamp":1745798400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ"],"accepted":{"date-parts":[[2025,1,31]]},"DOI":"10.1136\/bmj-2024-081660","type":"journal-article","created":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T03:54:58Z","timestamp":1745898898000},"page":"e081660","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":197,"title":["SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials"],"prefix":"10.1136","volume":"389","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2451-5012","authenticated-orcid":false,"given":"Asbj\u00f8rn","family":"Hr\u00f3bjartsson","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5263-6241","authenticated-orcid":false,"given":"Isabelle","family":"Boutron","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6881-6984","authenticated-orcid":false,"given":"Sally","family":"Hopewell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2434-4206","authenticated-orcid":false,"given":"David","family":"Moher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2596-7616","authenticated-orcid":false,"given":"Kenneth F","family":"Schulz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2772-2316","authenticated-orcid":false,"given":"Gary S","family":"Collins","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1187-1808","authenticated-orcid":false,"given":"Ruth","family":"Tunn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9689-494X","authenticated-orcid":false,"given":"Rakesh","family":"Aggarwal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-1316-5861","authenticated-orcid":false,"given":"Michael","family":"Berkwits","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9810-745X","authenticated-orcid":false,"given":"Jesse A","family":"Berlin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0349-087X","authenticated-orcid":false,"given":"Nita","family":"Bhandari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5152-0108","authenticated-orcid":false,"given":"Nancy J","family":"Butcher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5386-4097","authenticated-orcid":false,"given":"Marion K","family":"Campbell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6025-776X","authenticated-orcid":false,"given":"Runcie C W","family":"Chidebe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3044-4545","authenticated-orcid":false,"given":"Diana R","family":"Elbourne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6170-4402","authenticated-orcid":false,"given":"Andrew J","family":"Farmer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3389-2485","authenticated-orcid":false,"given":"Dean A","family":"Fergusson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert M","family":"Golub","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3872-5723","authenticated-orcid":false,"given":"Steven N","family":"Goodman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5210-8548","authenticated-orcid":false,"given":"Tammy C","family":"Hoffmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3118-6859","authenticated-orcid":false,"given":"John P A","family":"Ioannidis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9957-0844","authenticated-orcid":false,"given":"Brennan C","family":"Kahan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5490-7682","authenticated-orcid":false,"given":"Rachel L","family":"Knowles","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4349-7195","authenticated-orcid":false,"given":"Sarah E","family":"Lamb","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1210-2314","authenticated-orcid":false,"given":"Steff","family":"Lewis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1501-2947","authenticated-orcid":false,"given":"Elizabeth","family":"Loder","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4402-5299","authenticated-orcid":false,"given":"Martin","family":"Offringa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8264-9206","authenticated-orcid":false,"given":"Philippe","family":"Ravaud","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1151-0826","authenticated-orcid":false,"given":"Dawn P","family":"Richards","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3732-4765","authenticated-orcid":false,"given":"Frank W","family":"Rockhold","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0242-1127","authenticated-orcid":false,"given":"David L","family":"Schriger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4081-1698","authenticated-orcid":false,"given":"Nandi L","family":"Siegfried","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7723-9074","authenticated-orcid":false,"given":"Sophie","family":"Staniszewska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3043-6011","authenticated-orcid":false,"given":"Rod S","family":"Taylor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0355-9734","authenticated-orcid":false,"given":"Lehana","family":"Thabane","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1667-4275","authenticated-orcid":false,"given":"David J","family":"Torgerson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6210-7933","authenticated-orcid":false,"given":"Sunita","family":"Vohra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6718-7661","authenticated-orcid":false,"given":"Ian R","family":"White","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4498-3382","authenticated-orcid":false,"given":"An-Wen","family":"Chan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,4,28]]},"reference":[{"key":"2025042820251211000_389.apr28_6.e081660.1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.313.7057.570"},{"key":"2025042820251211000_389.apr28_6.e081660.2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.281053"},{"key":"2025042820251211000_389.apr28_6.e081660.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)60590-0"},{"key":"2025042820251211000_389.apr28_6.e081660.4","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-016-1743-0"},{"key":"2025042820251211000_389.apr28_6.e081660.5","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2009.04.003"},{"key":"2025042820251211000_389.apr28_6.e081660.6","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-3-201302050-00583"},{"key":"2025042820251211000_389.apr28_6.e081660.7","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c332"},{"key":"2025042820251211000_389.apr28_6.e081660.8","unstructured":"SPIRIT-CONSORT. 2024. https:\/\/www.consort-spirit.org\/"},{"key":"2025042820251211000_389.apr28_6.e081660.9","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2021-053417"},{"key":"2025042820251211000_389.apr28_6.e081660.10","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-06516-1"},{"key":"2025042820251211000_389.apr28_6.e081660.11","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2020-038283"},{"key":"2025042820251211000_389.apr28_6.e081660.12","doi-asserted-by":"publisher","DOI":"10.1186\/s41073-024-00147-7"},{"key":"2025042820251211000_389.apr28_6.e081660.13","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2024-081477"},{"key":"2025042820251211000_389.apr28_6.e081660.14","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2024-081123"},{"key":"2025042820251211000_389.apr28_6.e081660.15","unstructured":"World Health Organization. Guidance for best practices for clinical trials. 2024. https:\/\/www.who.int\/publications\/i\/item\/9789240097711."},{"key":"2025042820251211000_389.apr28_6.e081660.16","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1000217"},{"key":"2025042820251211000_389.apr28_6.e081660.17","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-022-01989-8"},{"key":"2025042820251211000_389.apr28_6.e081660.18","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2023.01.003"},{"key":"2025042820251211000_389.apr28_6.e081660.19","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2024.111309"},{"key":"2025042820251211000_389.apr28_6.e081660.20","doi-asserted-by":"publisher","DOI":"10.1002\/cesm.12057"},{"key":"2025042820251211000_389.apr28_6.e081660.21","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.m3210"},{"key":"2025042820251211000_389.apr28_6.e081660.22","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2022.21243"},{"key":"2025042820251211000_389.apr28_6.e081660.23","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.21903"},{"key":"2025042820251211000_389.apr28_6.e081660.24","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.g1687"},{"key":"2025042820251211000_389.apr28_6.e081660.25","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e7586"},{"key":"2025042820251211000_389.apr28_6.e081660.26","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-015-0460-y"},{"key":"2025042820251211000_389.apr28_6.e081660.27","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2023-073470"},{"key":"2025042820251211000_389.apr28_6.e081660.28","doi-asserted-by":"publisher","DOI":"10.1177\/016327870202500104"},{"key":"2025042820251211000_389.apr28_6.e081660.29","unstructured":"Australian and New Zealand Clinical Trials Registry: Sydney (NSW): NHMRC Clinical Trials Centre, University of Sydney (Australia); 2023 - Identifier ACTRN12624000133538. Encapsulated faecal microbiome transfer versus oral vancomycin treatment for sustained cure of recurrent or refractory Clostridioides difficile infection. https:\/\/www.anzctr.org.au\/Trial\/Registration\/TrialReview.aspx?id=386924."},{"key":"2025042820251211000_389.apr28_6.e081660.30","unstructured":"World Health Organization. WHO Trial Registration Data Set (Version 1.3.1). https:\/\/www.who.int\/clinical-trials-registry-platform\/network\/who-data-set [Accessed 12 Mar 2024]."},{"key":"2025042820251211000_389.apr28_6.e081660.31","unstructured":"European Commission. Clinical trials - Regulation EU No 536\/2014. 2022. https:\/\/health.ec.europa.eu\/medicinal-products\/clinical-trials\/clinical-trials-regulation-eu-no-5362014_en."},{"key":"2025042820251211000_389.apr28_6.e081660.32","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39233.510810.80"},{"key":"2025042820251211000_389.apr28_6.e081660.33","unstructured":"National Institutes of Health Department of Health and Human Services. Final Rule 81 FR 64982: Clinical Trials Registration and Results Information Submission. https:\/\/www.federalregister.gov\/documents\/2016\/09\/21\/2016-22129\/clinical-trials-registration-and-results-information-submission. 2016:64982-5157."},{"key":"2025042820251211000_389.apr28_6.e081660.34","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2212667"},{"key":"2025042820251211000_389.apr28_6.e081660.35","doi-asserted-by":"publisher","DOI":"10.1177\/2168479016632271"},{"key":"2025042820251211000_389.apr28_6.e081660.36","doi-asserted-by":"publisher","DOI":"10.1007\/s43441-024-00622-9"},{"key":"2025042820251211000_389.apr28_6.e081660.37","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2022-068487"},{"key":"2025042820251211000_389.apr28_6.e081660.38","doi-asserted-by":"publisher","DOI":"10.1001\/jama.295.14.1645"},{"key":"2025042820251211000_389.apr28_6.e081660.39","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0040019"},{"key":"2025042820251211000_389.apr28_6.e081660.40","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2020-036899"},{"key":"2025042820251211000_389.apr28_6.e081660.41","doi-asserted-by":"publisher","DOI":"10.1016\/J.EJCA.2016.06.023"},{"key":"2025042820251211000_389.apr28_6.e081660.42","unstructured":"JAMA Network. JAMA Instructions for Authors: authorship and disclosures. 2024. https:\/\/jamanetwork.com\/journals\/jama\/pages\/instructions-for-authors#SecAuthorshipandDisclosures."},{"key":"2025042820251211000_389.apr28_6.e081660.43","unstructured":"International Committee of Medical Journal Editors. Defining the Role of Authors and Contributors. https:\/\/www.icmje.org\/recommendations\/browse\/roles-and-responsibilities\/defining-the-role-of-authors-and-contributors.html."},{"key":"2025042820251211000_389.apr28_6.e081660.44","unstructured":"Com-COV3 Protocol Date & Version No. V11.0 13 Dec 2022. https:\/\/comcovstudy.org.uk\/sitefiles\/com-cov3-protocol-v11.0-13-dec-2023-unsigned.pdf."},{"key":"2025042820251211000_389.apr28_6.e081660.45","unstructured":"World Health Organization. Standards and operational guidance for ethics review of health-related research with human participants. 2011. https:\/\/www.who.int\/publications\/i\/item\/9789241502948."},{"key":"2025042820251211000_389.apr28_6.e081660.46","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Integrated addendum to ICH E6(R1): guideline for good clinical practice E6(R2). Step 4 version dated 9 November 2016. https:\/\/database.ich.org\/sites\/default\/files\/E6_R2_Addendum.pdf."},{"key":"2025042820251211000_389.apr28_6.e081660.47","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2023-075570"},{"key":"2025042820251211000_389.apr28_6.e081660.48","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa044115"},{"key":"2025042820251211000_389.apr28_6.e081660.49","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-12-9"},{"key":"2025042820251211000_389.apr28_6.e081660.50","doi-asserted-by":"publisher","DOI":"10.1186\/s12910-021-00681-9"},{"key":"2025042820251211000_389.apr28_6.e081660.51","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002046"},{"key":"2025042820251211000_389.apr28_6.e081660.52","doi-asserted-by":"publisher","DOI":"10.1002\/jrsm.1500"},{"key":"2025042820251211000_389.apr28_6.e081660.53","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-024-07952-x"},{"key":"2025042820251211000_389.apr28_6.e081660.54","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)17965-3"},{"key":"2025042820251211000_389.apr28_6.e081660.55","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-015-1125-z"},{"key":"2025042820251211000_389.apr28_6.e081660.56","doi-asserted-by":"publisher","DOI":"10.1186\/s12889-022-14183-9"},{"key":"2025042820251211000_389.apr28_6.e081660.57","unstructured":"UNESCO. UNESCO Recommendation on Open Science. 2021. https:\/\/unesdoc.unesco.org\/ark:\/48223\/pf0000379949."},{"key":"2025042820251211000_389.apr28_6.e081660.58","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(06)68708-4"},{"key":"2025042820251211000_389.apr28_6.e081660.59","doi-asserted-by":"publisher","DOI":"10.1001\/jama.290.4.516"},{"key":"2025042820251211000_389.apr28_6.e081660.60","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.330.7497.956"},{"key":"2025042820251211000_389.apr28_6.e081660.61","doi-asserted-by":"publisher","DOI":"10.1001\/jama.292.11.1363"},{"key":"2025042820251211000_389.apr28_6.e081660.62","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsr1601330"},{"key":"2025042820251211000_389.apr28_6.e081660.63","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.13001"},{"key":"2025042820251211000_389.apr28_6.e081660.64","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2023-076264"},{"key":"2025042820251211000_389.apr28_6.e081660.65","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2020.04.017"},{"key":"2025042820251211000_389.apr28_6.e081660.66","unstructured":"United States Congress. Food and Drug Administration Amendments Act of 2007, Title VIII, Section 801. Expanded clinical trial registry data bank. 2007. https:\/\/www.govtrack.us\/congress\/bills\/110\/hr3580\/text."},{"key":"2025042820251211000_389.apr28_6.e081660.67","unstructured":"SPIRIT Electronic Protocol Tool and Resource (SEPTRE). https:\/\/spiritprotocol.com [Accessed 19 Jun 2024]."},{"key":"2025042820251211000_389.apr28_6.e081660.68","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-020-04589-4"},{"key":"2025042820251211000_389.apr28_6.e081660.69","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2023-078645"},{"key":"2025042820251211000_389.apr28_6.e081660.70","unstructured":"International Conference on Harmonisation (ICH). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Statistical Principles for Clinical Trials E9. London, England: European Medicines Agency. 1998."},{"key":"2025042820251211000_389.apr28_6.e081660.71","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.18556"},{"key":"2025042820251211000_389.apr28_6.e081660.72","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-020-04828-8"},{"key":"2025042820251211000_389.apr28_6.e081660.73","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.9941"},{"key":"2025042820251211000_389.apr28_6.e081660.74","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0050230"},{"key":"2025042820251211000_389.apr28_6.e081660.75","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2022.05.014"},{"key":"2025042820251211000_389.apr28_6.e081660.76","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-06641-x"},{"key":"2025042820251211000_389.apr28_6.e081660.77","doi-asserted-by":"publisher","DOI":"10.1177\/1740774519868310"},{"key":"2025042820251211000_389.apr28_6.e081660.78","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-018-2510-1"},{"key":"2025042820251211000_389.apr28_6.e081660.79","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d8013"},{"key":"2025042820251211000_389.apr28_6.e081660.80","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d8141"},{"key":"2025042820251211000_389.apr28_6.e081660.81","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-019-3173-2"},{"key":"2025042820251211000_389.apr28_6.e081660.82","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-019-3172-3"},{"key":"2025042820251211000_389.apr28_6.e081660.83","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.j2372"},{"key":"2025042820251211000_389.apr28_6.e081660.84","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2018-024906"},{"key":"2025042820251211000_389.apr28_6.e081660.85","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2022-065295"},{"key":"2025042820251211000_389.apr28_6.e081660.86","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2015.3656"},{"key":"2025042820251211000_389.apr28_6.e081660.87","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0000308"},{"key":"2025042820251211000_389.apr28_6.e081660.88","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0230416"},{"key":"2025042820251211000_389.apr28_6.e081660.89","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2022.11.009"},{"key":"2025042820251211000_389.apr28_6.e081660.90","doi-asserted-by":"publisher","DOI":"10.1186\/s12910-020-0453-z"},{"key":"2025042820251211000_389.apr28_6.e081660.91","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.q324"},{"key":"2025042820251211000_389.apr28_6.e081660.92","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1001607"},{"key":"2025042820251211000_389.apr28_6.e081660.93","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.k400"},{"key":"2025042820251211000_389.apr28_6.e081660.94","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.15209"},{"key":"2025042820251211000_389.apr28_6.e081660.95","doi-asserted-by":"publisher","DOI":"10.1038\/s41597-023-02436-0"},{"key":"2025042820251211000_389.apr28_6.e081660.96","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.4590"},{"key":"2025042820251211000_389.apr28_6.e081660.97","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2021-049228"},{"key":"2025042820251211000_389.apr28_6.e081660.98","unstructured":"World Medical Association. World Medical Association statement on conflicts of interest. Adopted by the 60 WMA General Assembly, New Delhi, India, October 2009 and editorially revised by the 201st WMA Council Session, Moscow, Russia, October 2015. https:\/\/www.wma.net\/policies-post\/wma-statement-on-conflict-of-interest\/."},{"key":"2025042820251211000_389.apr28_6.e081660.99","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)61871-0"},{"key":"2025042820251211000_389.apr28_6.e081660.100","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-019-3253-3"},{"key":"2025042820251211000_389.apr28_6.e081660.101","doi-asserted-by":"publisher","DOI":"10.1007\/s00192-019-04209-z"},{"key":"2025042820251211000_389.apr28_6.e081660.102","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2017.12.018"},{"key":"2025042820251211000_389.apr28_6.e081660.103","doi-asserted-by":"publisher","DOI":"10.1038\/nrd.2017.70"},{"key":"2025042820251211000_389.apr28_6.e081660.104","doi-asserted-by":"publisher","DOI":"10.3310\/hta19880"},{"key":"2025042820251211000_389.apr28_6.e081660.105","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.k3654"},{"key":"2025042820251211000_389.apr28_6.e081660.106","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.MR000033.pub3"},{"key":"2025042820251211000_389.apr28_6.e081660.107","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.m3764"},{"key":"2025042820251211000_389.apr28_6.e081660.108","doi-asserted-by":"publisher","DOI":"10.1055\/a-2110-4259"},{"key":"2025042820251211000_389.apr28_6.e081660.109","unstructured":"Institute of Medicine . Conflict of interest in medical research, education, and practice. National Academies Press, 2009."},{"key":"2025042820251211000_389.apr28_6.e081660.110","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i6770"},{"key":"2025042820251211000_389.apr28_6.e081660.111","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-019-3239-1"},{"key":"2025042820251211000_389.apr28_6.e081660.112","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)62296-5"},{"key":"2025042820251211000_389.apr28_6.e081660.113","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1003980"},{"key":"2025042820251211000_389.apr28_6.e081660.114","doi-asserted-by":"publisher","DOI":"10.3310\/hta14080"},{"key":"2025042820251211000_389.apr28_6.e081660.115","article-title":"Publication bias in clinical trials due to statistical significance or direction of trial results","volume":"2009","author":"Hopewell","year":"2009","journal-title":"Cochrane Database Syst Rev"},{"key":"2025042820251211000_389.apr28_6.e081660.116","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0066844"},{"key":"2025042820251211000_389.apr28_6.e081660.117","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-11-37"},{"key":"2025042820251211000_389.apr28_6.e081660.118","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d7202"},{"key":"2025042820251211000_389.apr28_6.e081660.119","doi-asserted-by":"publisher","DOI":"10.1001\/archinternmed.2010.406"},{"key":"2025042820251211000_389.apr28_6.e081660.120","doi-asserted-by":"publisher","DOI":"10.1001\/jama.287.21.2825"},{"key":"2025042820251211000_389.apr28_6.e081660.121","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsr1611785"},{"key":"2025042820251211000_389.apr28_6.e081660.122","doi-asserted-by":"publisher","DOI":"10.1136\/bmjmed-2023-000738"},{"key":"2025042820251211000_389.apr28_6.e081660.123","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(24)00514-X"},{"key":"2025042820251211000_389.apr28_6.e081660.124","doi-asserted-by":"publisher","DOI":"10.1139\/facets-2022-0177"},{"key":"2025042820251211000_389.apr28_6.e081660.125","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i637"},{"key":"2025042820251211000_389.apr28_6.e081660.126","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.2351"},{"key":"2025042820251211000_389.apr28_6.e081660.127","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1001566"},{"key":"2025042820251211000_389.apr28_6.e081660.128","unstructured":"Sherpa Romeo. https:\/\/www.sherpa.ac.uk\/romeo\/ [Accessed 8 Nov 2023]."},{"key":"2025042820251211000_389.apr28_6.e081660.129","unstructured":"ASAPbio. Preprint resource centre. https:\/\/asapbio.org\/preprint-info [Accessed 8 Nov 2023]."},{"key":"2025042820251211000_389.apr28_6.e081660.130","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2020-041849"},{"key":"2025042820251211000_389.apr28_6.e081660.131","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.11127"},{"key":"2025042820251211000_389.apr28_6.e081660.132","doi-asserted-by":"publisher","DOI":"10.1136\/bmjmed-2022-000309"},{"key":"2025042820251211000_389.apr28_6.e081660.133","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2023.08.011"},{"key":"2025042820251211000_389.apr28_6.e081660.134","doi-asserted-by":"publisher","DOI":"10.1186\/s12874-023-02136-8"},{"key":"2025042820251211000_389.apr28_6.e081660.135","doi-asserted-by":"publisher","DOI":"10.1038\/s41562-016-0021"},{"key":"2025042820251211000_389.apr28_6.e081660.136","doi-asserted-by":"publisher","DOI":"10.1016\/j.conctc.2023.101136"},{"key":"2025042820251211000_389.apr28_6.e081660.137","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2021-057019"},{"key":"2025042820251211000_389.apr28_6.e081660.138","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2020-046851"},{"key":"2025042820251211000_389.apr28_6.e081660.139","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2022-067117"},{"key":"2025042820251211000_389.apr28_6.e081660.140","doi-asserted-by":"publisher","DOI":"10.1177\/20542704231166621"},{"key":"2025042820251211000_389.apr28_6.e081660.141","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)61045-8"},{"key":"2025042820251211000_389.apr28_6.e081660.142","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2023.4226"},{"key":"2025042820251211000_389.apr28_6.e081660.143","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-13-50"},{"key":"2025042820251211000_389.apr28_6.e081660.144","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0102670"},{"key":"2025042820251211000_389.apr28_6.e081660.145","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2010.01.022"},{"key":"2025042820251211000_389.apr28_6.e081660.146","unstructured":"Canadian Institutes of Health Research. RCT evaluation criteria and headings. 2024. https:\/\/www.cihr.ca\/e\/39187.html."},{"key":"2025042820251211000_389.apr28_6.e081660.147","unstructured":"British Heart Foundation. Clinical Study Grant full application guidance. https:\/\/www.bhf.org.uk\/for-professionals\/information-for-researchers\/what-we-fund\/clinical-study\/full-clinical-study-grant-application-guidance [Accessed 12 Sep 2023]."},{"key":"2025042820251211000_389.apr28_6.e081660.148","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)62229-1"},{"key":"2025042820251211000_389.apr28_6.e081660.149","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(04)17514-4"},{"key":"2025042820251211000_389.apr28_6.e081660.150","doi-asserted-by":"publisher","DOI":"10.1186\/1741-7015-6-28"},{"key":"2025042820251211000_389.apr28_6.e081660.151","doi-asserted-by":"publisher","DOI":"10.1191\/1740774505cn085oa"},{"key":"2025042820251211000_389.apr28_6.e081660.152","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-016-1713-6"},{"key":"2025042820251211000_389.apr28_6.e081660.153","doi-asserted-by":"publisher","DOI":"10.1016\/j.medj.2022.03.002"},{"key":"2025042820251211000_389.apr28_6.e081660.154","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2018-026661"},{"key":"2025042820251211000_389.apr28_6.e081660.155","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-020-04421-z"},{"key":"2025042820251211000_389.apr28_6.e081660.156","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1000111"},{"key":"2025042820251211000_389.apr28_6.e081660.157","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1L115"},{"key":"2025042820251211000_389.apr28_6.e081660.158","doi-asserted-by":"publisher","DOI":"10.1001\/jama.282.18.1752"},{"key":"2025042820251211000_389.apr28_6.e081660.159","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2015.08.016"},{"key":"2025042820251211000_389.apr28_6.e081660.160","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2021.03.023"},{"key":"2025042820251211000_389.apr28_6.e081660.161","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.171400"},{"key":"2025042820251211000_389.apr28_6.e081660.162","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)33137-X"},{"key":"2025042820251211000_389.apr28_6.e081660.163","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-06727-6"},{"key":"2025042820251211000_389.apr28_6.e081660.164","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2111673"},{"key":"2025042820251211000_389.apr28_6.e081660.165","unstructured":"Agency for Healthcare Research and Quality. Using the PICOTS Framework to Strengthen Evidence Gathered in Clinical Trials\u2014Guidance from the AHRQ\u2019s Evidence-based Practice Centers Program. https:\/\/www.fda.gov\/media\/109448\/download [Accessed 13 Mar 2024]."},{"key":"2025042820251211000_389.apr28_6.e081660.166","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i5078"},{"key":"2025042820251211000_389.apr28_6.e081660.167","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2012.87802"},{"key":"2025042820251211000_389.apr28_6.e081660.168","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2022-070146"},{"key":"2025042820251211000_389.apr28_6.e081660.169","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2023-076316"},{"key":"2025042820251211000_389.apr28_6.e081660.170","unstructured":"European Medicines Agency. ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-e9-r1-addendum-estimands-sensitivity-analysis-clinical-trials-guideline-statistical-principles_en.pdf. 2020."},{"key":"2025042820251211000_389.apr28_6.e081660.171","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2021-068177"},{"key":"2025042820251211000_389.apr28_6.e081660.172","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.19793"},{"key":"2025042820251211000_389.apr28_6.e081660.173","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2020.04.025"},{"key":"2025042820251211000_389.apr28_6.e081660.174","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2018.06.035"},{"key":"2025042820251211000_389.apr28_6.e081660.175","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.h2147"},{"key":"2025042820251211000_389.apr28_6.e081660.176","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-153-6-201009210-00008"},{"key":"2025042820251211000_389.apr28_6.e081660.177","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-06515-2"},{"key":"2025042820251211000_389.apr28_6.e081660.178","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2019-036366"},{"key":"2025042820251211000_389.apr28_6.e081660.179","unstructured":"NIHR. Briefing notes for researchers - public involvement in NHS, health and social care research. Version 1.0 - April 2021. https:\/\/www.nihr.ac.uk\/documents\/briefing-notes-for-researchers-public-involvement-in-nhs-health-and-social-care-research\/27371."},{"key":"2025042820251211000_389.apr28_6.e081660.180","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.2018.05067"},{"key":"2025042820251211000_389.apr28_6.e081660.181","doi-asserted-by":"publisher","DOI":"10.1186\/s40900-022-00350-0"},{"key":"2025042820251211000_389.apr28_6.e081660.182","unstructured":"NHMRC. Guidelines for guidelines: consumer involvement. https:\/\/www.nhmrc.gov.au\/guidelinesforguidelines\/plan\/consumer-involvement 2018."},{"key":"2025042820251211000_389.apr28_6.e081660.183","unstructured":"Consumers Health Forum of Australia. Statement on Consumer and Community involvement in Health and Medical Research. 2016. https:\/\/www.nhmrc.gov.au\/sites\/default\/files\/documents\/reports\/consumer-community-involvement.pdf."},{"key":"2025042820251211000_389.apr28_6.e081660.184","unstructured":"Canadian Institutes of Health Research. Strategy for Patient-Oriented Research: Patient Engagement Framework. https:\/\/cihr-irsc.gc.ca\/e\/documents\/spor_framework-en.pdf [Accessed 9 Sep 2023]."},{"key":"2025042820251211000_389.apr28_6.e081660.185","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2023.06.012"},{"key":"2025042820251211000_389.apr28_6.e081660.186","unstructured":"Staley K. Exploring Impact: Public involvement in NHS, public health and social care research. 2009. https:\/\/wellcomecollection.org\/works\/wtbmggvr."},{"key":"2025042820251211000_389.apr28_6.e081660.187","doi-asserted-by":"publisher","DOI":"10.1111\/jep.12805"},{"key":"2025042820251211000_389.apr28_6.e081660.188","doi-asserted-by":"publisher","DOI":"10.17226\/24739"},{"key":"2025042820251211000_389.apr28_6.e081660.189","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.j3453"},{"key":"2025042820251211000_389.apr28_6.e081660.190","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejogrb.2020.10.058"},{"key":"2025042820251211000_389.apr28_6.e081660.191","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2019.05.030"},{"key":"2025042820251211000_389.apr28_6.e081660.192","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.3087"},{"key":"2025042820251211000_389.apr28_6.e081660.193","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2023.46121"},{"key":"2025042820251211000_389.apr28_6.e081660.194","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.l4378"},{"key":"2025042820251211000_389.apr28_6.e081660.195","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e5661"},{"key":"2025042820251211000_389.apr28_6.e081660.196","doi-asserted-by":"publisher","DOI":"10.1001\/jama.295.10.1152"},{"key":"2025042820251211000_389.apr28_6.e081660.197","doi-asserted-by":"publisher","DOI":"10.1177\/1740774511410994"},{"key":"2025042820251211000_389.apr28_6.e081660.198","doi-asserted-by":"publisher","DOI":"10.1097\/00006454-200208000-00011"},{"key":"2025042820251211000_389.apr28_6.e081660.199","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2004.03.005"},{"key":"2025042820251211000_389.apr28_6.e081660.200","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.a2299"},{"key":"2025042820251211000_389.apr28_6.e081660.201","doi-asserted-by":"publisher","DOI":"10.1136\/bmjpo-2022-001629"},{"key":"2025042820251211000_389.apr28_6.e081660.202","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2023-076455"},{"key":"2025042820251211000_389.apr28_6.e081660.203","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyp305"},{"key":"2025042820251211000_389.apr28_6.e081660.204","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2023-074258"},{"key":"2025042820251211000_389.apr28_6.e081660.205","doi-asserted-by":"publisher","DOI":"10.3310\/hta3200"},{"key":"2025042820251211000_389.apr28_6.e081660.206","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.MR000021.pub3"},{"key":"2025042820251211000_389.apr28_6.e081660.207","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.23157"},{"key":"2025042820251211000_389.apr28_6.e081660.208","doi-asserted-by":"publisher","DOI":"10.1161\/01.STR.0000195149.44390.aa"},{"key":"2025042820251211000_389.apr28_6.e081660.209","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.15.3726"},{"key":"2025042820251211000_389.apr28_6.e081660.210","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.00.141"},{"key":"2025042820251211000_389.apr28_6.e081660.211","doi-asserted-by":"publisher","DOI":"10.1111\/j.1467-789X.2009.00567.x"},{"key":"2025042820251211000_389.apr28_6.e081660.212","doi-asserted-by":"publisher","DOI":"10.1161\/01.STR.32.4.909"},{"key":"2025042820251211000_389.apr28_6.e081660.213","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.163.2.185"},{"key":"2025042820251211000_389.apr28_6.e081660.214","doi-asserted-by":"publisher","DOI":"10.1001\/jama.297.11.1233"},{"key":"2025042820251211000_389.apr28_6.e081660.215","doi-asserted-by":"publisher","DOI":"10.1097\/01.aids.0000189866.67182.f7"},{"key":"2025042820251211000_389.apr28_6.e081660.216","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d1828"},{"key":"2025042820251211000_389.apr28_6.e081660.217","doi-asserted-by":"publisher","DOI":"10.2337\/dc06-0077"},{"key":"2025042820251211000_389.apr28_6.e081660.218","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.090523"},{"key":"2025042820251211000_389.apr28_6.e081660.219","doi-asserted-by":"publisher","DOI":"10.1002\/jrsm.1688"},{"key":"2025042820251211000_389.apr28_6.e081660.220","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2022-062721"},{"key":"2025042820251211000_389.apr28_6.e081660.221","doi-asserted-by":"publisher","DOI":"10.7326\/M17-0046"},{"key":"2025042820251211000_389.apr28_6.e081660.222","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-148-4-200802190-00008"},{"key":"2025042820251211000_389.apr28_6.e081660.223","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-137-6-200209170-00012"},{"key":"2025042820251211000_389.apr28_6.e081660.224","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.330.7482.88"},{"key":"2025042820251211000_389.apr28_6.e081660.225","doi-asserted-by":"publisher","DOI":"10.1001\/jama.284.24.3139"},{"key":"2025042820251211000_389.apr28_6.e081660.226","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.11517"},{"key":"2025042820251211000_389.apr28_6.e081660.227","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpsychores.2020.110132"},{"key":"2025042820251211000_389.apr28_6.e081660.228","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-021-05778-5"},{"key":"2025042820251211000_389.apr28_6.e081660.229","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)60329-9"},{"key":"2025042820251211000_389.apr28_6.e081660.230","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1003294"},{"key":"2025042820251211000_389.apr28_6.e081660.231","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2021.6203"},{"key":"2025042820251211000_389.apr28_6.e081660.232","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa2209760"},{"key":"2025042820251211000_389.apr28_6.e081660.233","unstructured":"US Food and Drug Administration. CFR - Code of Federal Regulations Title 21, Chapter I, Subchapter D, Part 312: Investigational new drug application. https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=312&showFR=1&subpartNode=21:5.0.1.1.3.4 [Accessed 12 Sep 2023]."},{"key":"2025042820251211000_389.apr28_6.e081660.234","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.l4898"},{"key":"2025042820251211000_389.apr28_6.e081660.235","unstructured":"Panel on Handling Missing Data in Clinical Trials, National Research Council . The Prevention and Treatment of Missing Data in Clinical Trials. National Academies Press, 2010."},{"key":"2025042820251211000_389.apr28_6.e081660.236","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMOA2214676"},{"key":"2025042820251211000_389.apr28_6.e081660.237","doi-asserted-by":"publisher","DOI":"10.5014\/ajot.2013.006213"},{"key":"2025042820251211000_389.apr28_6.e081660.238","unstructured":"World Health Organization . Adherence to long-term therapies: evidence for action. WHO, 2003."},{"key":"2025042820251211000_389.apr28_6.e081660.239","doi-asserted-by":"publisher","DOI":"10.1016\/0021-9681(67)90041-0"},{"key":"2025042820251211000_389.apr28_6.e081660.240","doi-asserted-by":"publisher","DOI":"10.1177\/0141076817706303"},{"key":"2025042820251211000_389.apr28_6.e081660.241","doi-asserted-by":"publisher","DOI":"10.1177\/01410768231207536"},{"key":"2025042820251211000_389.apr28_6.e081660.242","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2014.59"},{"key":"2025042820251211000_389.apr28_6.e081660.243","doi-asserted-by":"publisher","DOI":"10.1007\/BF03256784"},{"key":"2025042820251211000_389.apr28_6.e081660.244","unstructured":"European Medicines Agency. ICH E3 Structure and Content of Clinical Study Reports (CPMP\/ICH\/137\/95). 1996. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-e-3-structure-content-clinical-study-reports-step-5_en.pdf"},{"key":"2025042820251211000_389.apr28_6.e081660.245","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.9508"},{"key":"2025042820251211000_389.apr28_6.e081660.246","doi-asserted-by":"publisher","DOI":"10.1177\/1740774511410995"},{"key":"2025042820251211000_389.apr28_6.e081660.247","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-024-08022-y"},{"key":"2025042820251211000_389.apr28_6.e081660.248","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-023-07272-6"},{"key":"2025042820251211000_389.apr28_6.e081660.249","doi-asserted-by":"publisher","DOI":"10.1001\/jama.291.20.2457"},{"key":"2025042820251211000_389.apr28_6.e081660.250","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.1041086"},{"key":"2025042820251211000_389.apr28_6.e081660.251","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa1012065"},{"key":"2025042820251211000_389.apr28_6.e081660.252","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.f4313"},{"key":"2025042820251211000_389.apr28_6.e081660.253","doi-asserted-by":"publisher","DOI":"10.1002\/sim.7390"},{"key":"2025042820251211000_389.apr28_6.e081660.254","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c7153"},{"key":"2025042820251211000_389.apr28_6.e081660.255","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2013.06.020"},{"key":"2025042820251211000_389.apr28_6.e081660.256","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0050217"},{"key":"2025042820251211000_389.apr28_6.e081660.257","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.MR000031.pub2"},{"key":"2025042820251211000_389.apr28_6.e081660.258","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2017.05.012"},{"key":"2025042820251211000_389.apr28_6.e081660.259","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-016-1189-4"},{"key":"2025042820251211000_389.apr28_6.e081660.260","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d80"},{"key":"2025042820251211000_389.apr28_6.e081660.261","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2017.05.007"},{"key":"2025042820251211000_389.apr28_6.e081660.262","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2018.08.020"},{"key":"2025042820251211000_389.apr28_6.e081660.263","doi-asserted-by":"publisher","DOI":"10.1258\/jhsrp.2011.011131"},{"key":"2025042820251211000_389.apr28_6.e081660.264","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2020.09.029"},{"key":"2025042820251211000_389.apr28_6.e081660.265","unstructured":"The COMET Initiative. https:\/\/www.comet-initiative.org\/ [Accessed 19 Jun 2024]."},{"key":"2025042820251211000_389.apr28_6.e081660.266","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdw682"},{"key":"2025042820251211000_389.apr28_6.e081660.267","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2023.102283"},{"key":"2025042820251211000_389.apr28_6.e081660.268","doi-asserted-by":"publisher","DOI":"10.1007\/s004020100347"},{"key":"2025042820251211000_389.apr28_6.e081660.269","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2007.10.006"},{"key":"2025042820251211000_389.apr28_6.e081660.270","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.17743"},{"key":"2025042820251211000_389.apr28_6.e081660.271","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2023.11.001"},{"key":"2025042820251211000_389.apr28_6.e081660.272","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-06493-5"},{"key":"2025042820251211000_389.apr28_6.e081660.273","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2022-073725"},{"key":"2025042820251211000_389.apr28_6.e081660.274","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200528100-00003"},{"key":"2025042820251211000_389.apr28_6.e081660.275","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx043"},{"key":"2025042820251211000_389.apr28_6.e081660.276","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2021.10.023"},{"key":"2025042820251211000_389.apr28_6.e081660.277","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-144-4-200602210-00007"},{"key":"2025042820251211000_389.apr28_6.e081660.278","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMe068054"},{"key":"2025042820251211000_389.apr28_6.e081660.279","doi-asserted-by":"publisher","DOI":"10.1001\/jama.286.19.2398"},{"key":"2025042820251211000_389.apr28_6.e081660.280","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2019.04.022"},{"key":"2025042820251211000_389.apr28_6.e081660.281","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2019.04.020"},{"key":"2025042820251211000_389.apr28_6.e081660.282","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002101"},{"key":"2025042820251211000_389.apr28_6.e081660.283","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2017.75.8193"},{"key":"2025042820251211000_389.apr28_6.e081660.284","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1103464"},{"key":"2025042820251211000_389.apr28_6.e081660.285","doi-asserted-by":"publisher","DOI":"10.1186\/s12891-017-1681-3"},{"key":"2025042820251211000_389.apr28_6.e081660.286","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-4356(99)00141-9"},{"key":"2025042820251211000_389.apr28_6.e081660.287","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S188752"},{"key":"2025042820251211000_389.apr28_6.e081660.288","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2022-062338"},{"key":"2025042820251211000_389.apr28_6.e081660.289","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2018-028613"},{"key":"2025042820251211000_389.apr28_6.e081660.290","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-014-0526-8"},{"key":"2025042820251211000_389.apr28_6.e081660.291","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.k3750"},{"key":"2025042820251211000_389.apr28_6.e081660.292","unstructured":"Cochrane Prospective Meta-Analysis (PMA) Methods Group . https:\/\/methods.cochrane.org\/pma\/ 2024."},{"key":"2025042820251211000_389.apr28_6.e081660.293","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.b1732"},{"key":"2025042820251211000_389.apr28_6.e081660.294","doi-asserted-by":"publisher","DOI":"10.1016\/j.joca.2023.09.002"},{"key":"2025042820251211000_389.apr28_6.e081660.295","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-4356(03)00141-0"},{"key":"2025042820251211000_389.apr28_6.e081660.296","doi-asserted-by":"publisher","DOI":"10.1002\/bimj.200800266"},{"key":"2025042820251211000_389.apr28_6.e081660.297","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.f1135"},{"key":"2025042820251211000_389.apr28_6.e081660.298","doi-asserted-by":"publisher","DOI":"10.1081\/BIP-100101174"},{"key":"2025042820251211000_389.apr28_6.e081660.299","doi-asserted-by":"publisher","DOI":"10.2105\/AJPH.2007.127027"},{"key":"2025042820251211000_389.apr28_6.e081660.300","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39517.495764.25"},{"key":"2025042820251211000_389.apr28_6.e081660.301","doi-asserted-by":"publisher","DOI":"10.1191\/1740774504cn006rr"},{"key":"2025042820251211000_389.apr28_6.e081660.302","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djn066"},{"key":"2025042820251211000_389.apr28_6.e081660.303","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2014.09.015"},{"key":"2025042820251211000_389.apr28_6.e081660.304","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i5239"},{"key":"2025042820251211000_389.apr28_6.e081660.305","doi-asserted-by":"publisher","DOI":"10.1186\/s40814-021-00770-x"},{"key":"2025042820251211000_389.apr28_6.e081660.306","doi-asserted-by":"publisher","DOI":"10.1097\/mlr.0000000000001664"},{"key":"2025042820251211000_389.apr28_6.e081660.307","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-024-08042-8"},{"key":"2025042820251211000_389.apr28_6.e081660.308","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-023-07710-5"},{"key":"2025042820251211000_389.apr28_6.e081660.309","doi-asserted-by":"publisher","DOI":"10.3310\/hta11480"},{"key":"2025042820251211000_389.apr28_6.e081660.310","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(03)12799-7"},{"key":"2025042820251211000_389.apr28_6.e081660.311","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2016-015276"},{"key":"2025042820251211000_389.apr28_6.e081660.312","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1000368"},{"key":"2025042820251211000_389.apr28_6.e081660.313","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.MR000013.pub6"},{"key":"2025042820251211000_389.apr28_6.e081660.314","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3956(98)00045-4"},{"key":"2025042820251211000_389.apr28_6.e081660.315","first-page":"73","article-title":"Mailing strategies and recruitment into an intervention trial of the exercise effect on breast cancer biomarkers","volume":"11","author":"Tworoger","year":"2002","journal-title":"Cancer Epidemiol Biomarkers Prev"},{"key":"2025042820251211000_389.apr28_6.e081660.316","doi-asserted-by":"publisher","DOI":"10.1177\/1740774509346703"},{"key":"2025042820251211000_389.apr28_6.e081660.317","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2022.10.014"},{"key":"2025042820251211000_389.apr28_6.e081660.318","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-023-07491-x"},{"key":"2025042820251211000_389.apr28_6.e081660.319","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-023-07464-0"},{"key":"2025042820251211000_389.apr28_6.e081660.320","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0273755"},{"key":"2025042820251211000_389.apr28_6.e081660.321","unstructured":"Schulz KF Grimes DA . Essential Concepts in Clinical Research: randomized controlled trials and observational epidemiology. 2nd ed. Elsevier, 2019."},{"key":"2025042820251211000_389.apr28_6.e081660.322","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-10-46"},{"key":"2025042820251211000_389.apr28_6.e081660.323","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c869"},{"key":"2025042820251211000_389.apr28_6.e081660.324","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.MR000012.pub3"},{"key":"2025042820251211000_389.apr28_6.e081660.325","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-157-6-201209180-00537"},{"key":"2025042820251211000_389.apr28_6.e081660.326","doi-asserted-by":"publisher","DOI":"10.3310\/hta16150"},{"key":"2025042820251211000_389.apr28_6.e081660.327","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwx344"},{"key":"2025042820251211000_389.apr28_6.e081660.328","doi-asserted-by":"publisher","DOI":"10.1177\/0022034517725049"},{"key":"2025042820251211000_389.apr28_6.e081660.329","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.38414.422650.8F"},{"key":"2025042820251211000_389.apr28_6.e081660.330","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2011.10.016"},{"key":"2025042820251211000_389.apr28_6.e081660.331","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0289038"},{"key":"2025042820251211000_389.apr28_6.e081660.332","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-12-S1-A14"},{"key":"2025042820251211000_389.apr28_6.e081660.333","doi-asserted-by":"publisher","DOI":"10.1177\/009286150303700305"},{"key":"2025042820251211000_389.apr28_6.e081660.334","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(02)07683-3"},{"key":"2025042820251211000_389.apr28_6.e081660.335","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.319.7211.703"},{"key":"2025042820251211000_389.apr28_6.e081660.336","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1995.03520290060030"},{"key":"2025042820251211000_389.apr28_6.e081660.337","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-4356(98)00138-3"},{"key":"2025042820251211000_389.apr28_6.e081660.338","doi-asserted-by":"publisher","DOI":"10.1002\/sim.3710"},{"key":"2025042820251211000_389.apr28_6.e081660.339","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-14-86"},{"key":"2025042820251211000_389.apr28_6.e081660.340","unstructured":"Altman DG . Practical statistics for medical research. Chapman & Hall\/CRC, 1991."},{"key":"2025042820251211000_389.apr28_6.e081660.341","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.317.7155.362"},{"key":"2025042820251211000_389.apr28_6.e081660.342","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcrc.2006.01.002"},{"key":"2025042820251211000_389.apr28_6.e081660.343","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2010.05.001"},{"key":"2025042820251211000_389.apr28_6.e081660.344","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-07008-y"},{"key":"2025042820251211000_389.apr28_6.e081660.345","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-023-07541-4"},{"key":"2025042820251211000_389.apr28_6.e081660.346","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(02)07750-4"},{"key":"2025042820251211000_389.apr28_6.e081660.347","doi-asserted-by":"publisher","DOI":"10.1111\/jep.12032"},{"key":"2025042820251211000_389.apr28_6.e081660.348","doi-asserted-by":"publisher","DOI":"10.12688\/f1000research.27918.1"},{"key":"2025042820251211000_389.apr28_6.e081660.349","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2010.12.018"},{"key":"2025042820251211000_389.apr28_6.e081660.350","article-title":"Randomisation to protect against selection bias in healthcare trials","volume":"2","author":"Kunz","year":"2007","journal-title":"Cochrane Database Syst Rev"},{"key":"2025042820251211000_389.apr28_6.e081660.351","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-023-07383-0"},{"key":"2025042820251211000_389.apr28_6.e081660.352","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-021-05499-9"},{"key":"2025042820251211000_389.apr28_6.e081660.353","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-06517-0"},{"key":"2025042820251211000_389.apr28_6.e081660.354","doi-asserted-by":"publisher","DOI":"10.1186\/s40814-023-01306-1"},{"key":"2025042820251211000_389.apr28_6.e081660.355","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD003974.pub3"},{"key":"2025042820251211000_389.apr28_6.e081660.356","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e1119"},{"key":"2025042820251211000_389.apr28_6.e081660.357","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyu115"},{"key":"2025042820251211000_389.apr28_6.e081660.358","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.323.7303.42"},{"key":"2025042820251211000_389.apr28_6.e081660.359","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyh300"},{"key":"2025042820251211000_389.apr28_6.e081660.360","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.b3244"},{"key":"2025042820251211000_389.apr28_6.e081660.361","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-136-3-200202050-00022"},{"key":"2025042820251211000_389.apr28_6.e081660.362","doi-asserted-by":"publisher","DOI":"10.1016\/0197-2456(95)00263-4"},{"key":"2025042820251211000_389.apr28_6.e081660.363","doi-asserted-by":"publisher","DOI":"10.3310\/hta9400"},{"key":"2025042820251211000_389.apr28_6.e081660.364","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0030425"},{"key":"2025042820251211000_389.apr28_6.e081660.365","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0040061"},{"key":"2025042820251211000_389.apr28_6.e081660.366","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-9-48"},{"key":"2025042820251211000_389.apr28_6.e081660.367","doi-asserted-by":"publisher","DOI":"10.1001\/jama.285.15.2000"},{"key":"2025042820251211000_389.apr28_6.e081660.368","doi-asserted-by":"publisher","DOI":"10.1177\/1740774506069153"},{"key":"2025042820251211000_389.apr28_6.e081660.369","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0290725"},{"key":"2025042820251211000_389.apr28_6.e081660.370","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2017.03.001"},{"key":"2025042820251211000_389.apr28_6.e081660.371","article-title":"Impact of active placebo controls on estimated drug effects in randomised trials: a systematic review of trials with both active placebo and standard placebo","volume":"3","author":"Laursen","year":"2023","journal-title":"Cochrane Database Syst Rev"},{"key":"2025042820251211000_389.apr28_6.e081660.372","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2016.08.002"},{"key":"2025042820251211000_389.apr28_6.e081660.373","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.37952.631667.EE"},{"key":"2025042820251211000_389.apr28_6.e081660.374","doi-asserted-by":"publisher","DOI":"10.1177\/1740774511419685"},{"key":"2025042820251211000_389.apr28_6.e081660.375","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)60413-8"},{"key":"2025042820251211000_389.apr28_6.e081660.376","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2014.05.007"},{"key":"2025042820251211000_389.apr28_6.e081660.377","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2011.207"},{"key":"2025042820251211000_389.apr28_6.e081660.378","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-023-07540-5"},{"key":"2025042820251211000_389.apr28_6.e081660.379","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-06683-1"},{"key":"2025042820251211000_389.apr28_6.e081660.380","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-023-07666-6"},{"key":"2025042820251211000_389.apr28_6.e081660.381","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djp386"},{"key":"2025042820251211000_389.apr28_6.e081660.382","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keh152"},{"key":"2025042820251211000_389.apr28_6.e081660.383","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2004.03.025"},{"key":"2025042820251211000_389.apr28_6.e081660.384","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-144-4-200602210-00007"},{"key":"2025042820251211000_389.apr28_6.e081660.385","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13285"},{"key":"2025042820251211000_389.apr28_6.e081660.386","doi-asserted-by":"publisher","DOI":"10.1016\/j.pec.2008.07.011"},{"key":"2025042820251211000_389.apr28_6.e081660.387","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2020-045105"},{"key":"2025042820251211000_389.apr28_6.e081660.388","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.176.3.249"},{"key":"2025042820251211000_389.apr28_6.e081660.389","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n450"},{"key":"2025042820251211000_389.apr28_6.e081660.390","doi-asserted-by":"publisher","DOI":"10.1177\/1740774506073104"},{"key":"2025042820251211000_389.apr28_6.e081660.391","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0110229"},{"key":"2025042820251211000_389.apr28_6.e081660.392","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-023-07363-4"},{"key":"2025042820251211000_389.apr28_6.e081660.393","doi-asserted-by":"publisher","DOI":"10.1136\/jech.51.4.354"},{"key":"2025042820251211000_389.apr28_6.e081660.394","doi-asserted-by":"publisher","DOI":"10.1002\/gps.2211"},{"key":"2025042820251211000_389.apr28_6.e081660.395","article-title":"Strategies to improve retention in randomised trials","volume":"3","author":"Gillies","year":"2021","journal-title":"Cochrane Database Syst Rev"},{"key":"2025042820251211000_389.apr28_6.e081660.396","unstructured":"PRincipleS for handling end-of-participation EVEnts in clinical trials REsearch: the PeRSEVERE principles. https:\/\/persevereprinciples.org\/the-persevere-principles\/ [Accessed 8 Nov 2023]."},{"key":"2025042820251211000_389.apr28_6.e081660.397","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-154-2-201101180-00010"},{"key":"2025042820251211000_389.apr28_6.e081660.398","doi-asserted-by":"publisher","DOI":"10.1002\/pst.189"},{"key":"2025042820251211000_389.apr28_6.e081660.399","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-024-07969-2"},{"key":"2025042820251211000_389.apr28_6.e081660.400","doi-asserted-by":"publisher","DOI":"10.47912\/jscdm.116"},{"key":"2025042820251211000_389.apr28_6.e081660.401","unstructured":"NIH. Data management and sharing policy. https:\/\/sharing.nih.gov\/data-management-and-sharing-policy\/data-management#:~:text=NIH%20encourages%20data%20management%20and,repurposing%20datasets%20for%20secondary%20research. 2023."},{"key":"2025042820251211000_389.apr28_6.e081660.402","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2017.05.004"},{"key":"2025042820251211000_389.apr28_6.e081660.403","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0025348"},{"key":"2025042820251211000_389.apr28_6.e081660.404","doi-asserted-by":"publisher","DOI":"10.1177\/009286150103500321"},{"key":"2025042820251211000_389.apr28_6.e081660.405","doi-asserted-by":"publisher","DOI":"10.1016\/S0197-2456(03)00089-8"},{"key":"2025042820251211000_389.apr28_6.e081660.406","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-023-07275-3"},{"key":"2025042820251211000_389.apr28_6.e081660.407","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2022-069915"},{"key":"2025042820251211000_389.apr28_6.e081660.408","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-15-139"},{"key":"2025042820251211000_389.apr28_6.e081660.409","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-06097-z"},{"key":"2025042820251211000_389.apr28_6.e081660.410","doi-asserted-by":"publisher","DOI":"10.1016\/j.annepidem.2005.09.007"},{"key":"2025042820251211000_389.apr28_6.e081660.411","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyw320"},{"key":"2025042820251211000_389.apr28_6.e081660.412","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1709701"},{"key":"2025042820251211000_389.apr28_6.e081660.413","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2021.12.023"},{"key":"2025042820251211000_389.apr28_6.e081660.414","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.l5342"},{"key":"2025042820251211000_389.apr28_6.e081660.415","doi-asserted-by":"publisher","DOI":"10.1002\/sim.10060"},{"key":"2025042820251211000_389.apr28_6.e081660.416","doi-asserted-by":"publisher","DOI":"10.1007\/s43441-022-00482-1"},{"key":"2025042820251211000_389.apr28_6.e081660.417","doi-asserted-by":"publisher","DOI":"10.1016\/j.conctc.2020.100658"},{"key":"2025042820251211000_389.apr28_6.e081660.418","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-06544-x"},{"key":"2025042820251211000_389.apr28_6.e081660.419","doi-asserted-by":"publisher","DOI":"10.1177\/01410768231203922"},{"key":"2025042820251211000_389.apr28_6.e081660.420","doi-asserted-by":"publisher","DOI":"10.1177\/01410768231203936"},{"key":"2025042820251211000_389.apr28_6.e081660.421","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0049163"},{"key":"2025042820251211000_389.apr28_6.e081660.422","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-14-118"},{"key":"2025042820251211000_389.apr28_6.e081660.423","doi-asserted-by":"publisher","DOI":"10.1177\/1740774518812774"},{"key":"2025042820251211000_389.apr28_6.e081660.424","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.h2445"},{"key":"2025042820251211000_389.apr28_6.e081660.425","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-023-07670-w"},{"key":"2025042820251211000_389.apr28_6.e081660.426","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e2809"},{"key":"2025042820251211000_389.apr28_6.e081660.427","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2015-008431"},{"key":"2025042820251211000_389.apr28_6.e081660.428","doi-asserted-by":"publisher","DOI":"10.1186\/s12874-017-0442-1"},{"key":"2025042820251211000_389.apr28_6.e081660.429","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2022.08.016"},{"key":"2025042820251211000_389.apr28_6.e081660.430","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyu080"},{"key":"2025042820251211000_389.apr28_6.e081660.431","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d40"},{"key":"2025042820251211000_389.apr28_6.e081660.432","doi-asserted-by":"publisher","DOI":"10.1016\/j.cjca.2020.11.010"},{"key":"2025042820251211000_389.apr28_6.e081660.433","doi-asserted-by":"publisher","DOI":"10.1177\/1740774515602688"},{"key":"2025042820251211000_389.apr28_6.e081660.434","doi-asserted-by":"publisher","DOI":"10.1177\/02692163211065597"},{"key":"2025042820251211000_389.apr28_6.e081660.435","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.b2393"},{"key":"2025042820251211000_389.apr28_6.e081660.436","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-019-3731-7"},{"key":"2025042820251211000_389.apr28_6.e081660.437","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-024-07996-z"},{"key":"2025042820251211000_389.apr28_6.e081660.438","doi-asserted-by":"publisher","DOI":"10.1111\/eci.13145"},{"key":"2025042820251211000_389.apr28_6.e081660.439","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2021.31503"},{"key":"2025042820251211000_389.apr28_6.e081660.440","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2018.12.009"},{"key":"2025042820251211000_389.apr28_6.e081660.441","doi-asserted-by":"publisher","DOI":"10.1007\/s11886-014-0531-2"},{"key":"2025042820251211000_389.apr28_6.e081660.442","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-10-33"},{"key":"2025042820251211000_389.apr28_6.e081660.443","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2016.9125"},{"key":"2025042820251211000_389.apr28_6.e081660.444","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c117"},{"key":"2025042820251211000_389.apr28_6.e081660.445","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-14-11"},{"key":"2025042820251211000_389.apr28_6.e081660.446","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-13-92"},{"key":"2025042820251211000_389.apr28_6.e081660.447","doi-asserted-by":"publisher","DOI":"10.1038\/s41433-022-02108-0"},{"key":"2025042820251211000_389.apr28_6.e081660.448","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-024-07920-5"},{"key":"2025042820251211000_389.apr28_6.e081660.449","doi-asserted-by":"publisher","DOI":"10.1111\/aas.13795"},{"key":"2025042820251211000_389.apr28_6.e081660.450","doi-asserted-by":"publisher","DOI":"10.1191\/1740774504cn003oa"},{"key":"2025042820251211000_389.apr28_6.e081660.451","doi-asserted-by":"publisher","DOI":"10.1002\/sim.730"},{"key":"2025042820251211000_389.apr28_6.e081660.452","doi-asserted-by":"publisher","DOI":"10.1177\/1740774517707743"},{"key":"2025042820251211000_389.apr28_6.e081660.453","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2012.3424"},{"key":"2025042820251211000_389.apr28_6.e081660.454","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2015.05.023"},{"key":"2025042820251211000_389.apr28_6.e081660.455","doi-asserted-by":"publisher","DOI":"10.1002\/9781119512684"},{"key":"2025042820251211000_389.apr28_6.e081660.456","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-06196-x"},{"key":"2025042820251211000_389.apr28_6.e081660.457","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2023.552"},{"key":"2025042820251211000_389.apr28_6.e081660.458","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(99)03464-9"},{"key":"2025042820251211000_389.apr28_6.e081660.459","doi-asserted-by":"publisher","DOI":"10.1177\/17407745231203391"},{"key":"2025042820251211000_389.apr28_6.e081660.460","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-13-145"},{"key":"2025042820251211000_389.apr28_6.e081660.461","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-9-46"},{"key":"2025042820251211000_389.apr28_6.e081660.462","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2021-056191"},{"key":"2025042820251211000_389.apr28_6.e081660.463","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-018-3081-x"},{"key":"2025042820251211000_389.apr28_6.e081660.464","unstructured":"TransCelerate Biopharma Inc. Risk-based monitoring. https:\/\/www.transceleratebiopharmainc.com\/initiatives\/risk-based-monitoring\/ [Accessed 6 Dec 2023]."},{"key":"2025042820251211000_389.apr28_6.e081660.465","unstructured":"UKCRC Registered CTU Network. Monitoring of clinical trials: a handbook v1.0. 2021. https:\/\/ukcrc-ctu.org.uk\/download\/6577\/?tmstv=1696335948."},{"key":"2025042820251211000_389.apr28_6.e081660.466","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-06763-2"},{"key":"2025042820251211000_389.apr28_6.e081660.467","doi-asserted-by":"publisher","DOI":"10.1177\/17407745221143449"},{"key":"2025042820251211000_389.apr28_6.e081660.468","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2024.6228"},{"key":"2025042820251211000_389.apr28_6.e081660.469","doi-asserted-by":"publisher","DOI":"10.1007\/s43441-024-00613-w"},{"key":"2025042820251211000_389.apr28_6.e081660.470","article-title":"Monitoring strategies for clinical intervention studies","volume":"12","author":"Klatte","year":"2021","journal-title":"Cochrane Database Syst Rev"},{"key":"2025042820251211000_389.apr28_6.e081660.471","unstructured":"World Medical Association. WMA Declaration of Helsinki - ethical principles for medical research involving human subjects. 2022. https:\/\/www.wma.net\/policies-post\/wma-declaration-of-helsinki\/"},{"key":"2025042820251211000_389.apr28_6.e081660.472","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-023-07795-y"},{"key":"2025042820251211000_389.apr28_6.e081660.473","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.313.7067.1245"},{"key":"2025042820251211000_389.apr28_6.e081660.474","doi-asserted-by":"publisher","DOI":"10.1177\/009286151104500307"},{"key":"2025042820251211000_389.apr28_6.e081660.475","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa065779"},{"key":"2025042820251211000_389.apr28_6.e081660.476","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-4356(00)00227-4"},{"key":"2025042820251211000_389.apr28_6.e081660.477","unstructured":"Chappell L, Alfirevich Z, Chien P, Jarvis S, Thornton JG. A comparison of the published version of randomized controlled trials in a specialist clinical journal with the original trial protocols [abstract]. International Congress on Peer Review and Biomedical Publication; 16-18 Sept 2005; Chicago, Illinois, USA. 2005:27."},{"key":"2025042820251211000_389.apr28_6.e081660.478","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/ken190"},{"key":"2025042820251211000_389.apr28_6.e081660.479","doi-asserted-by":"publisher","DOI":"10.1016\/j.spinee.2007.01.008"},{"key":"2025042820251211000_389.apr28_6.e081660.480","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)61060-0"},{"key":"2025042820251211000_389.apr28_6.e081660.481","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-8-16"},{"key":"2025042820251211000_389.apr28_6.e081660.482","unstructured":"US Food and Drug Administration. Code of Federal Regulations, Title 21, Volume 5, 21CFR312.30. 2011."},{"key":"2025042820251211000_389.apr28_6.e081660.483","unstructured":"European Commission. Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1) (2010\/C 82\/01). Official Journal of the European Union. 2010."},{"key":"2025042820251211000_389.apr28_6.e081660.484","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-016-1236-1"},{"key":"2025042820251211000_389.apr28_6.e081660.485","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-018-2755-8"},{"key":"2025042820251211000_389.apr28_6.e081660.486","doi-asserted-by":"publisher","DOI":"10.1093\/fampra\/20.1.83"},{"key":"2025042820251211000_389.apr28_6.e081660.487","unstructured":"Fayter D, McDaid C, Ritchie G, Stirk L, Eastwood A. Systematic review of barriers, modifiers and benefits involved in participation in cancer trials. Centre for Reviews and Dissemination report 31. University of York; 2006. Report No 31."},{"key":"2025042820251211000_389.apr28_6.e081660.488","doi-asserted-by":"publisher","DOI":"10.1016\/j.surg.2005.08.014"},{"key":"2025042820251211000_389.apr28_6.e081660.489","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD003717.pub3"},{"key":"2025042820251211000_389.apr28_6.e081660.490","doi-asserted-by":"publisher","DOI":"10.1136\/jme.2004.011114"},{"key":"2025042820251211000_389.apr28_6.e081660.491","doi-asserted-by":"publisher","DOI":"10.1186\/s12911-021-01390-4"},{"key":"2025042820251211000_389.apr28_6.e081660.492","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-12-202"},{"key":"2025042820251211000_389.apr28_6.e081660.493","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-022-06929-y"},{"key":"2025042820251211000_389.apr28_6.e081660.494","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0013302"},{"key":"2025042820251211000_389.apr28_6.e081660.495","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejmg.2016.04.002"},{"key":"2025042820251211000_389.apr28_6.e081660.496","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2212616"},{"key":"2025042820251211000_389.apr28_6.e081660.497","unstructured":"UpGuard. Clinical Trials: How Personal Information for Thousands of Australians was Exposed. 2019. www.upguard.com\/breaches\/data-leak-neoclinical-australia-new-zealand."},{"key":"2025042820251211000_389.apr28_6.e081660.498","doi-asserted-by":"publisher","DOI":"10.1186\/s12910-019-0359-9"},{"key":"2025042820251211000_389.apr28_6.e081660.499","doi-asserted-by":"publisher","DOI":"10.1186\/s12874-016-0169-4"},{"key":"2025042820251211000_389.apr28_6.e081660.500","doi-asserted-by":"publisher","DOI":"10.12688\/f1000research.144139.1"},{"key":"2025042820251211000_389.apr28_6.e081660.501","doi-asserted-by":"publisher","DOI":"10.2307\/3528248"},{"key":"2025042820251211000_389.apr28_6.e081660.502","doi-asserted-by":"publisher","DOI":"10.1177\/1740774518792277"},{"key":"2025042820251211000_389.apr28_6.e081660.503","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.20-1178"},{"key":"2025042820251211000_389.apr28_6.e081660.504","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.m122"},{"key":"2025042820251211000_389.apr28_6.e081660.505","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2023-076386"},{"key":"2025042820251211000_389.apr28_6.e081660.506","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2023-078525"},{"key":"2025042820251211000_389.apr28_6.e081660.507","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(21)00344-2"},{"key":"2025042820251211000_389.apr28_6.e081660.508","doi-asserted-by":"publisher","DOI":"10.1007\/s11655-018-2999-x"},{"key":"2025042820251211000_389.apr28_6.e081660.509","doi-asserted-by":"publisher","DOI":"10.1186\/s13643-023-02363-6"}],"container-title":["BMJ"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/data.bmj.org\/tdm\/10.1136\/bmj-2024-081660","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmj-2024-081660","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T03:55:35Z","timestamp":1745898935000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.bmj.com\/lookup\/doi\/10.1136\/bmj-2024-081660"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4,28]]},"references-count":509,"alternative-id":["10.1136\/bmj-2024-081660"],"URL":"https:\/\/doi.org\/10.1136\/bmj-2024-081660","relation":{},"ISSN":["1756-1833"],"issn-type":[{"value":"1756-1833","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4,28]]}}}