Abstract
Incomplete information about existing research is an underlying cause of research waste. National and international initiatives and requirements have been launched to address this issue. To characterize current clinical trial transparency policies among the largest noncommercial US funders and examine whether the policies are concordant with international funders. This retrospective review of public information used methods developed for documenting funder policies internationally; 2 researchers searched each funder's website and Google between May and November 2018 to locate trial transparency policies for 10 top US funders. Key informants at each funding organization were contacted by email and given 3 or more weeks to review and confirm or correct the findings. Nonresponders were contacted 2 or more additional times. Descriptive statistics were calculated to summarize the findings. The study was conducted using publicly available policy information with findings confirmed by funder representatives where possible. Participants included top 10 noncommercial US health research funders with the highest reported investment in health research (2013 dollars) who fund clinical trials. Data analysis was conducted from November 6, 2018, to November 23, 2018. Availability of policies addressing each of the 3 key trial transparency domains as specified by the World Health Organization in 2017. Independent assessment by 2 investigators of availability (yes or no) of a policy addressing registration for trials, sharing of summary results, and individual participant data sharing activities; requirements (yes, no, or supportive statement) of these policies in terms of completeness, timeliness, public access, and provision of additional technical or financial support to meet data sharing requirements; description (yes or no) of internal monitoring for policy adherence. All 10 funders acknowledged the outreach. One funder who indicated that less than 1% of their research funding goes to clinical trials was removed. Six (67%) of the remaining 9 top US funders have a publicly available written policy for all 3 major trial transparency domains. The most comprehensive trial transparency practice among US funders addresses summary results sharing as follows: 8 of 9 US funders (89%) have a policy, 5 of 9 US funders (56%) require reporting of summary results within 1 year, and 6 of 9 US funders (67%) monitor compliance with their summary results sharing policy. For clinical trial registration, 7 of 9 US funders (78%) have a policy and 5 of 9 US funders (56%) require registration and monitor trial registration to measure adherence to the policy. In this study, overall the proportion of US funders with policies and practices to support trial transparency in this sample was similar or compared favorably with the larger international sample of noncommercial funders recently reported.
Highlights
Over the past 20 years,[1] national and international initiatives have been launched to improve clinical trial registration and reporting.[2,3,4] Incomplete information about existing research is an underlying cause of research waste[5] and undermines credible, efficient production of research to support health care decision making.[6]
One funder who indicated that less than 1% of their research funding goes to clinical trials was removed
In this review study, 6 of 9 (67%) of the top US funders have a publicly available written policy addressing all 3 major trial transparency domains
Summary
Over the past 20 years,[1] national and international initiatives have been launched to improve clinical trial registration and reporting.[2,3,4] Incomplete information about existing research is an underlying cause of research waste[5] and undermines credible, efficient production of research to support health care decision making.[6] Trial registries afford the means to capture a minimum, structured information set from all ongoing and completed clinical trials in humans and to make these publicly accessible. Under Title VIII of the US Food and Drug Administration Amendments Act of 2007 (FDAAA)[8] and subsequent rule making by the US Department of Health and Human Services in 2016,9 US research sponsors and principal investigators have a clear, legally binding trial reporting obligation. Despite growing requirements and opportunities for trial registry and reporting, US academic institutions (a common research sponsor in the United States) may be incompletely prepared[11] or lag in their duty to completely report their clinical trials’ planning, conduct, and results to the public in timely and transparent ways.[7]
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