{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T04:05:21Z","timestamp":1783397121378,"version":"3.54.6"},"update-to":[{"DOI":"10.12688\/wellcomeopenres.23135.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,3,6]],"date-time":"2025-03-06T00:00:00Z","timestamp":1741219200000}}],"reference-count":11,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2025,3,6]],"date-time":"2025-03-06T00:00:00Z","timestamp":1741219200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"publisher","award":["303666"],"award-info":[{"award-number":["303666"]}],"id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["INV-063472"],"award-info":[{"award-number":["INV-063472"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000278","name":"Department for International Development, UK Government","doi-asserted-by":"publisher","award":["301542-403"],"award-info":[{"award-number":["301542-403"]}],"id":[{"id":"10.13039\/501100000278","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["wellcomeopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Wellcome Open Res"],"abstract":"<ns3:p>Objective Synthesise the published literature and national regulations on infrastructure, capabilities and capacities required to manage and quality assure clinical research. Introduction The World Health Assembly (WHA) resolution 75.8 (2022) called \u201cfor a strengthened global architecture for coordinated and high-quality clinical trials\u201d. For this remit, infrastructure, capabilities, and capacities needed to design and deliver high-quality clinical trials must be understood and advanced. This rapid scoping review aims to identify the breadth of requirements and recommendations for effective management of clinical trials in regulations, national legislation and the published literature. The findings will be summarised into themes. It will inform a framework for the assessment and development of units undertaking observational studies and interventional clinical trials. Inclusion criteria Peer-reviewed literature, grey literature, and national legislation that recommends infrastructure, capabilities, and\/or capacities needed to manage and quality assure clinical trials. Publications authored by those who design, manage, fund, sponsor, regulate or oversee clinical trials. Methods Peer-reviewed and grey literature will be identified through Medline, Embase, PsycINFO, and Global Health via Ovid; SCOPUS; the Web of Science Core Collection; and the WHO Global Index Medicus using specific field codes to increase the specificity of the search strings. No date, language, or geographic limits will be applied. Deduplicated titles and abstracts will be screened by two blinded reviewers with discrepancies resolved by a third reviewer. Grey literature may be identified through the peer reviewed literature, supplemented with structured searches of Google and DynaMed. National regulations will be sourced online and from available summaries. Full text literature and regulations will be screened by a single reviewer, with proportionate verification by a second reviewer. Data will be extracted and coded for patterns in NVivo software. All items and codes will be summarised using a thematic framework analysis and identify core constructs within each theme.<\/ns3:p>","DOI":"10.12688\/wellcomeopenres.23135.2","type":"journal-article","created":{"date-parts":[[2025,3,6]],"date-time":"2025-03-06T11:10:12Z","timestamp":1741259412000},"page":"729","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Infrastructure, capabilities, and capacities required for clinical trials design and delivery: A rapid scoping review of recommendations and regulations"],"prefix":"10.12688","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4168-1960","authenticated-orcid":false,"given":"Laura","family":"Merson","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karolina","family":"Witt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6359-6070","authenticated-orcid":false,"given":"Arishay","family":"Hussaini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1555-720X","authenticated-orcid":false,"given":"Ayesha","family":"Siddiqui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eli","family":"Harriss","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9134-9045","authenticated-orcid":false,"given":"Steve","family":"Webb","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Njuguna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Divya","family":"K Shah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"An-Wen","family":"Chan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3849-7705","authenticated-orcid":false,"given":"Robert","family":"Terry","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nandi","family":"Siegfried","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8926-1861","authenticated-orcid":false,"given":"Jeni","family":"Stolow","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8463-1341","authenticated-orcid":false,"given":"Emmanuelle","family":"Denis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7332-0692","authenticated-orcid":false,"given":"Madiha","family":"Hashmi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2560","published-online":{"date-parts":[[2025,3,6]]},"reference":[{"key":"ref-1","doi-asserted-by":"publisher","first-page":"254-5","DOI":"10.1038\/d41573-021-00037-3","article-title":"Trends in COVID-19 therapeutic clinical trials.","volume":"20","author":"K Bugin","year":"2021","journal-title":"Nat Rev Drug Discov."},{"key":"ref-2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.0444","article-title":"Geographical representation of low- and middle-income countries in Randomized Clinical Trials for COVID-19.","volume":"5","author":"M Ramanan","year":"2022","journal-title":"JAMA Network Open."},{"key":"ref-3","article-title":"Number of clinical trials by year, country, region and income group"},{"key":"ref-4","article-title":"BioStudy rules.","year":"2017"},{"key":"ref-5","article-title":"Standards for clinical trials site.","year":"2014"},{"key":"ref-6","article-title":"UKCRC Registered CTU network key competencies and evaluation criteria.","year":"2023"},{"key":"ref-7","article-title":"Chapter 11: Scoping Reviews (2020 version).","author":"M Peters","year":"2020"},{"key":"ref-8","doi-asserted-by":"publisher","first-page":"467-73","DOI":"10.7326\/M18-0850","article-title":"PRISMA extension for Scoping Reviews (PRISMA-ScR): checklist and explanation.","volume":"169","author":"A Tricco","year":"2018","journal-title":"Ann Intern Med."},{"key":"ref-9","article-title":"Infrastructure, capabilities, and capacities required for clinical trials design and delivery: a rapid scoping review of recommendations and regulations.","author":"L Merson","year":"2024"},{"key":"ref-10","doi-asserted-by":"publisher","first-page":"394-404","DOI":"10.1002\/jrsm.1555","article-title":"Methodological guidance for rapid reviews in healthcare: a scoping review.","volume":"13","author":"C Speckemeier","year":"2022","journal-title":"Res Synth Methods."},{"key":"ref-11","article-title":"Using the TDR global competency framework for clinical research:a set of tools to help develop clinical researchers","year":"2016"}],"container-title":["Wellcome Open Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-729\/v2\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-729\/v2\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-729\/v2\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,19]],"date-time":"2025-03-19T17:35:23Z","timestamp":1742405723000},"score":1,"resource":{"primary":{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-729\/v2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,6]]},"references-count":11,"URL":"https:\/\/doi.org\/10.12688\/wellcomeopenres.23135.2","relation":{"has-version":[{"id-type":"doi","id":"10.12688\/wellcomeopenres.23135.1","asserted-by":"subject"}],"has-review":[{"id-type":"doi","id":"10.21956\/wellcomeopenres.26355.r120247","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.26355.r120247","asserted-by":"object"}]},"ISSN":["2398-502X"],"issn-type":[{"value":"2398-502X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,6]]},"assertion":[{"value":"Indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-729\/v2#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/wellcomeopenres.25475.r116965, James Spicer, King's College London, London, 20 Jan 2025, version 1, 1 approved, 1 approved with reservations","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-729\/v1#referee-response-116965","order":0,"name":"referee-response-116965","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Ayesha Siddiqui<\/b>; \n<i>Posted: 27 Feb 2025<\/i>; Thank you for your detailed and thoughtful feedback. We appreciate the emphasis on critically reviewing regulatory frameworks rather than simply cataloguing them. While our primary aim is to map existing regulations and recommendations, we recognize the importance of highlighting areas where rigid regulatory structures may hinder trial innovation and efficiency. We will ensure that our synthesis acknowledges divergences in regulatory approaches, including those that allow for risk-proportional tolerance, particularly in different research contexts such as healthy volunteer studies versus trials involving critically ill patients. To your point on eligibility criteria and the potential limitations of overly narrow selection criteria, where relevant, we will capture discussions in the literature regarding the balance between scientific rigor and real-world applicability in clinical trials. Regarding the impact of the COVID-19 pandemic on trial infrastructure and conduct, we agree that assessing whether challenges stemmed from systemic deficiencies or shifting research priorities is important. However, as our scoping review is intended to inform a maturity framework, it does not fall within our remit to evaluate the underlying causes of these changes. We will document reported changes in trial conduct and infrastructural requirements in crisis and pandemic situations. Thank you again for your constructive comments, which will help refine the focus of our review.","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-729\/v2#referee-comment-6052","order":1,"name":"referee-comment-6052","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.26355.r120247, William J Cragg, University of Leeds, Leeds, England, 19 Mar 2025, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-729\/v2#referee-response-120247","order":2,"name":"referee-response-120247","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work was supported by the Wellcome Trust (Grant No. 303666, awarded to Peter Horby) for the project titled ISARIC 3.0: Strengthening the Global Clinical Research Ecosystem for Epidemic and Pandemic Prevention and Preparedness. Additional funding was provided by the Department for International Development, UK Government (Grant No. 301542-403), and the Bill & Melinda Gates Foundation (Grant No. INV-063472). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":3,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}