{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T03:24:50Z","timestamp":1769916290852,"version":"3.49.0"},"reference-count":33,"publisher":"Cambridge University Press (CUP)","issue":"1","license":[{"start":{"date-parts":[[2024,10,17]],"date-time":"2024-10-17T00:00:00Z","timestamp":1729123200000},"content-version":"unspecified","delay-in-days":290,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Clin. Trans. Sci."],"published-print":{"date-parts":[[2024]]},"abstract":"<jats:title>Abstract<\/jats:title>\n\t  <jats:sec id=\"S2059866124006472_as1\">\n\t    <jats:title>Introduction:<\/jats:title>\n\t    <jats:p>Researchers and policymakers recognize that leveraging data routinely collected in clinical practice can support improved research and patient care. Embedding elements of clinical trials, such as patient identification and trial data acquisition, into clinical practice can enable research access and increase efficiencies by reducing duplication of trial and care activities. Yet, cultural, administrative, and data barriers exist. The Clinical Trials Transformation Initiative (CTTI) developed evidenced-based, multi-partner recommendations to facilitate embedding interventional, randomized trials into clinical practice.<\/jats:p>\n\t  <\/jats:sec>\n\t  <jats:sec id=\"S2059866124006472_as2\">\n\t    <jats:title>Methods:<\/jats:title>\n\t    <jats:p>We conducted in-depth interviews (IDIs) with trial designers and implementers to describe their motivations for embedding interventional, randomized trials into clinical practice. Additionally, we aimed to identify barriers and potential solutions to implementing such trials. Interviews were audio-recorded and analyzed using applied thematic analysis.<\/jats:p>\n\t  <\/jats:sec>\n\t  <jats:sec id=\"S2059866124006472_as3\">\n\t    <jats:title>Results:<\/jats:title>\n\t    <jats:p>We conducted 16 IDIs with 18 trial designers and implementers. Motivations for embedding trials into clinical practice included the desire to implement a learning health system and evaluate trials in real-world settings. Barriers to trial implementation focused on limited staff time and availability, the lack of buy-in, and difficulties using electronic health record data. Solutions included minimizing healthcare settings and patient burden, having a sufficient data and research infrastructure in place, and creating a culture change.<\/jats:p>\n\t  <\/jats:sec>\n\t  <jats:sec id=\"S2059866124006472_as4\">\n\t    <jats:title>Conclusion:<\/jats:title>\n\t    <jats:p>The results informed CTTI recommendations to facilitate the design and operation of embedded trials. These recommendations emphasize areas where sponsors and investigators can rethink the design and conduct of clinical trials to ultimately realize an aligned system of research and care.<\/jats:p>\n\t  <\/jats:sec>","DOI":"10.1017\/cts.2024.647","type":"journal-article","created":{"date-parts":[[2024,10,17]],"date-time":"2024-10-17T00:41:02Z","timestamp":1729125662000},"source":"Crossref","is-referenced-by-count":1,"title":["Embedding clinical trial elements into clinical practice: Experiences from trial designers and implementers"],"prefix":"10.1017","volume":"8","author":[{"given":"Carrie","family":"Dombeck","sequence":"first","affiliation":[{"name":"Duke University School of Medicine"},{"name":"Duke University School of Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teresa","family":"Swezey","sequence":"additional","affiliation":[{"name":"Duke University School of Medicine"},{"name":"Duke University School of Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5434-443X","authenticated-orcid":false,"given":"Lindsay","family":"Kehoe","sequence":"additional","affiliation":[{"name":"Duke University School of Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kraig","family":"Kinchen","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Roe","sequence":"additional","affiliation":[{"name":"AstraZeneca"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Stewart","sequence":"additional","affiliation":[{"name":"Friends of Cancer Research"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy","family":"Corneli","sequence":"additional","affiliation":[{"name":"Duke University School of Medicine"},{"name":"Duke University School of Medicine"},{"name":"Duke University School of Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"56","published-online":{"date-parts":[[2024,10,17]]},"reference":[{"key":"S2059866124006472_ref24","unstructured":"24. QSR International Pty Ltd. NVivo qualitative data analysis software. 12.1.90 ed. 2018."},{"key":"S2059866124006472_ref15","unstructured":"15. Clinical Trials Transformation Initiative. CTTI Recommendations: Embedding Clinical Trial Elements into Clinical Practice. (https:\/\/ctti-clinicaltrials.org\/wp-content\/uploads\/2022\/12\/CTTI_Recommendations_Embedding_Trials_in_Clinical_Practice_December_2022.pdf) Accessed August 3, 2023."},{"key":"S2059866124006472_ref33","unstructured":"33. ARPA-H Advances initiative to improve clinical trials. (\u223chttps:\/\/arpa-h.gov\/news-and-events\/arpa-h-advances-initiative-improve-clinical-trials#:~:text=The%20goal%20of%20Advancing%20Clinical,half%20hour%20of%20their%20home) Accessed 02\/16\/2024."},{"key":"S2059866124006472_ref2","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-015-1023-4"},{"key":"S2059866124006472_ref17","doi-asserted-by":"publisher","DOI":"10.1002\/1098-240X(200008)23:4<334::AID-NUR9>3.0.CO;2-G"},{"key":"S2059866124006472_ref30","unstructured":"30. Australian Clinical Trials Alliance. Embedding Clinical Trials in Healthcare. (https:\/\/clinicaltrialsalliance.org.au\/group\/embedding-clinical-trials-in-healthcare\/) Accessed June 27, 2024."},{"key":"S2059866124006472_ref7","doi-asserted-by":"publisher","DOI":"10.1177\/1740774520928426"},{"key":"S2059866124006472_ref27","unstructured":"27. Clinical Trials Transformation Initiative. Welcome to the Embedding Trials Feasibility Survey. (https:\/\/redcap.duke.edu\/redcap\/surveys\/?s=ATKD3NXM373JA9N3) Accessed June 27, 2024."},{"key":"S2059866124006472_ref26","unstructured":"26. PCORnet Common Data Model (CDM). (https:\/\/pcornet.org\/wp-content\/uploads\/2023\/04\/PCORnet-Common-Data-Model-v61-2023_04_031.pdf) Accessed August 3, 2023."},{"key":"S2059866124006472_ref31","unstructured":"31. Duke-Margolis Center Health Policy Center. Point-of-Care Clinical Trials: Integrating Research and Care Delivery. (https:\/\/healthpolicy.duke.edu\/publications\/point-care-clinical-trials-integrating-research-and-care-delivery) Accessed August 3, 2023."},{"key":"S2059866124006472_ref23","doi-asserted-by":"publisher","DOI":"10.4135\/9781483384436"},{"key":"S2059866124006472_ref25","first-page":"1609406919899220","volume-title":"Int J Qual Methods","volume":"19","author":"Saldana","year":"2021"},{"key":"S2059866124006472_ref12","unstructured":"12. PRECIS-2. (https:\/\/www.precis-2.org\/) Accessed August 3, 2023.,"},{"key":"S2059866124006472_ref32","unstructured":"32. Coalition for Advancing Clinical Trials at the Point of Care. (https:\/\/actpoc.org\/) Accessed February 16, 2024."},{"key":"S2059866124006472_ref28","doi-asserted-by":"publisher","DOI":"10.7861\/fhj.2021-0083"},{"key":"S2059866124006472_ref13","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.h2147"},{"key":"S2059866124006472_ref4","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2022.4810"},{"key":"S2059866124006472_ref19","doi-asserted-by":"publisher","DOI":"10.1002\/9781405165518.wbeoss012.pub2"},{"key":"S2059866124006472_ref16","doi-asserted-by":"publisher","DOI":"10.1177\/1740774518755054"},{"key":"S2059866124006472_ref22","doi-asserted-by":"publisher","DOI":"10.1177\/1525822X02239573"},{"key":"S2059866124006472_ref14","unstructured":"14. Clinical Trials Transformation Initiative. Embedding Clinical Trials into Clinical Practice. (https:\/\/ctti-clinicaltrials.org\/our-work\/novel-clinical-trial-designs\/integrating-clinical-care\/) Accessed August 3, 2023."},{"key":"S2059866124006472_ref8","doi-asserted-by":"publisher","DOI":"10.1186\/s12874-017-0420-7"},{"key":"S2059866124006472_ref5","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2022-073100"},{"key":"S2059866124006472_ref3","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(04)17670-8"},{"key":"S2059866124006472_ref29","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.3284"},{"key":"S2059866124006472_ref9","unstructured":"9. NIH. NIH Pragmatic Trials Collaboratory. (https:\/\/rethinkingclinicaltrials.org\/about-nih-collaboratory) Accessed June 27, 2024."},{"key":"S2059866124006472_ref10","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2021.03.021"},{"key":"S2059866124006472_ref1","volume-title":"Institute of Medicine (US) Roundtable on Evidence-Based Medicine","author":"Olsen","year":"2007"},{"key":"S2059866124006472_ref20","unstructured":"20. ClinicalTrials.gov. (https:\/\/www.clinicaltrials.gov\/) Accessed August 3, 2023."},{"key":"S2059866124006472_ref18","doi-asserted-by":"publisher","DOI":"10.1002\/nur.20362"},{"key":"S2059866124006472_ref21","doi-asserted-by":"publisher","DOI":"10.1177\/1049732315617444"},{"key":"S2059866124006472_ref11","doi-asserted-by":"publisher","DOI":"10.1111\/jep.13216"},{"key":"S2059866124006472_ref6","doi-asserted-by":"publisher","DOI":"10.1002\/lrh2.10044"}],"container-title":["Journal of Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S2059866124006472","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T14:31:23Z","timestamp":1759847483000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S2059866124006472\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024]]},"references-count":33,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024]]}},"alternative-id":["S2059866124006472"],"URL":"https:\/\/doi.org\/10.1017\/cts.2024.647","relation":{},"ISSN":["2059-8661"],"issn-type":[{"value":"2059-8661","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024]]},"article-number":"202"}}