{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T11:32:55Z","timestamp":1775561575316,"version":"3.50.1"},"reference-count":17,"publisher":"Cambridge University Press (CUP)","issue":"1","license":[{"start":{"date-parts":[[2021,10,7]],"date-time":"2021-10-07T00:00:00Z","timestamp":1633564800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Clin. Trans. Sci."],"published-print":{"date-parts":[[2022]]},"abstract":"<jats:title>Abstract<\/jats:title>\n\t  <jats:sec id=\"S2059866121008669_abs1\">\n\t    <jats:title>Background:<\/jats:title>\n\t    <jats:p>The Clinical and Translational Science Award Program (CTSA) Trial Innovation Network (TIN) was launched in 2016 to increase the efficiency and effectiveness of multisite trials by supporting the development of national infrastructure. With the advent of the COVID-19 pandemic, it was therefore well-positioned to support clinical trial collaboration. The TIN was leveraged to support two initiatives: (1) to create and evaluate a mechanism for coordinating Data and Safety Monitoring Board (DSMB) activities among multiple ongoing trials of the same therapeutic agents, and (2) to share data across clinical trials so that smaller, likely underpowered studies, could be combined to produce meaningful and actionable data through pooled analyses. The success of these initiatives was understood to be dependent upon the willingness of investigators, study teams, and US National Institutes of Health research networks to collaborate and share information.<\/jats:p>\n\t  <\/jats:sec>\n\t  <jats:sec id=\"S2059866121008669_abs1a\">\n\t    <jats:title>Methods:<\/jats:title>\n\t    <jats:p>To inform these two initiatives, we conducted semistructured interviews with members of CTSA hubs and clinical research stakeholders that probed barriers and facilitators to collaboration. Thematic analysis identified topics relevant across institutions, individuals, and DSMBs.<\/jats:p>\n\t  <\/jats:sec>\n\t  <jats:sec id=\"S2059866121008669_abs1b\">\n\t    <jats:title>Results:<\/jats:title>\n\t    <jats:p>The DSMB coordination initiative was viewed as less controversial, while the data pooling initiative was seen as complex because of its potential impact on publication, authorship, and the rewards of discovery. Barriers related to resources, centralization, and technical work were significant, but interviewees suggested these could be handled by the provision of central funding and supportive frameworks. The more intractable findings were related to issues around credit and ownership of data.<\/jats:p>\n\t  <\/jats:sec>\n\t  <jats:sec id=\"S2059866121008669_abs1c\">\n\t    <jats:title>Conclusion:<\/jats:title>\n\t    <jats:p>Based on our interviews, we conclude with nine recommended actions that can be implemented to support collaboration.<\/jats:p>\n\t  <\/jats:sec>","DOI":"10.1017\/cts.2021.866","type":"journal-article","created":{"date-parts":[[2021,10,7]],"date-time":"2021-10-07T03:50:42Z","timestamp":1633578642000},"source":"Crossref","is-referenced-by-count":7,"title":["Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis"],"prefix":"10.1017","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9760-7196","authenticated-orcid":false,"given":"Marisha E.","family":"Palm","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3297-2811","authenticated-orcid":false,"given":"Christopher J.","family":"Lindsell","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harry P.","family":"Selker","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"56","published-online":{"date-parts":[[2021,10,7]]},"reference":[{"key":"S2059866121008669_ref14","doi-asserted-by":"publisher","DOI":"10.1097\/PHH.0b013e3182205087"},{"key":"S2059866121008669_ref6","unstructured":"6. CTSA Program Hubs: Clinical and Translational Science Awards (CTSA) Program. National Institutes of Health . 2021. (https:\/\/ncats.nih.gov\/ctsa\/about\/hubs)."},{"key":"S2059866121008669_ref3","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00023-07"},{"key":"S2059866121008669_ref8","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12463"},{"key":"S2059866121008669_ref9","unstructured":"9. Health NIo. CTSA Program PAR-18-940 Application Information . 2020. (https:\/\/ncats.nih.gov\/ctsa\/funding\/par-information)."},{"key":"S2059866121008669_ref16","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsb1616595"},{"key":"S2059866121008669_ref10","doi-asserted-by":"publisher","DOI":"10.5430\/jnep.v6n5p100"},{"key":"S2059866121008669_ref15","doi-asserted-by":"publisher","DOI":"10.1038\/s41893-018-0085-1"},{"key":"S2059866121008669_ref17","doi-asserted-by":"publisher","DOI":"10.1038\/d41586-019-01715-4"},{"key":"S2059866121008669_ref12","first-page":"1033","article-title":"Toward rigorous data harmonization in cancer epidemiology research: one approach","volume":"182","author":"Rolland","year":"2015","journal-title":"American Journal of Epidemiology"},{"key":"S2059866121008669_ref7","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2018.319"},{"key":"S2059866121008669_ref13","doi-asserted-by":"publisher","DOI":"10.1093\/ser\/mwy033"},{"key":"S2059866121008669_ref4","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.m1167"},{"key":"S2059866121008669_ref5","unstructured":"5. NIH Launches National Consortium to Transform Clinical Research. 2006. (https:\/\/www.nih.gov\/news-events\/news-releases\/nih-launches-national-consortium-transform-clinical-research)."},{"key":"S2059866121008669_ref2","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2020.3391"},{"key":"S2059866121008669_ref11","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/28.1.1"},{"key":"S2059866121008669_ref1","unstructured":"1. Rolling updates on coronavirus disease (COVID-19). World Health Organization , 2020, (https:\/\/www.who.int\/emergencies\/diseases\/novel-coronavirus-2019\/events-as-they-happen)."}],"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\/S2059866121008669","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,16]],"date-time":"2022-05-16T11:37:36Z","timestamp":1652701056000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S2059866121008669\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,10,7]]},"references-count":17,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022]]}},"alternative-id":["S2059866121008669"],"URL":"https:\/\/doi.org\/10.1017\/cts.2021.866","relation":{},"ISSN":["2059-8661"],"issn-type":[{"value":"2059-8661","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,10,7]]},"article-number":"e52"}}