Noncommercial US Funders’ Policies on Trial Registration, Access to Summary Results, and Individual Patient Data Availability

IMPORTANCE 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. OBJECTIVES To characterize current clinical trial transparency policies among the largest noncommercial US funders and examine whether the policies are concordant with international funders. DESIGN, SETTING, AND PARTICIPANTS 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. EXPOSURES Availability of policies addressing each of the 3 key trial transparency domains as specified by the World Health Organization in 2017. CONCLUSIONS AND RELEVANCE 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.


DESIGN, SETTING, AND PARTICIPANTS
MAIN OUTCOMES AND MEASURES 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.
RESULTS 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.

Introduction
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 They must register and report summary results from applicable clinical trials of FDA-regulated drug, biologic, and device products on ClinicalTrials.gov within set timelines, with possible penalties to be imposed for failure to meet these requirements. 10 Nonetheless, 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 It should be noted that the FDAAA regulatory requirements for reporting specific clinical trials in the United States directly apply to research sponsors or their delegates and not to funding whether US funders' public policies addressing trial reporting transparency are generally concordant or appear to deviate from the international community was of interest.

Methods
Using a public website, we identified 81 health research funding organizations in the United States and 73 of these had annual health research expenditures reported for 2013. 15 We eliminated 13 additional funders for whom health-related clinical trials are not the norm (eg, the US Department of Labor and the US Department of the Interior) and 1 funder (ie, Howard Hughes Medical Institute) who had previously reported they do not fund clinical trials. 14 Of the remaining 60 funders, 10 were selected with the highest reported investment in health research for review (Table 1)

Results
All funders acknowledged our outreach. Six of 9 funders (67%) provided comments or corrections to the study's findings. One funder who indicated that less than 1% of their research funding goes to clinical trials was removed. Based on the study's findings (

Discussion
Overall, the proportion of funders with policies and practices to support trial transparency in this US sample was similar or compared favorably with the larger international sample of noncommercial funders recently reported. 14 This is despite the fact that the responsibility for US funders may be somewhat lessened compared with international colleagues by the presence of clear regulatory requirements for sponsors through the FDAAA. To some degree, US funders in addition to the NIH sharing. However, the data sharing aspect of trials transparency is changing rapidly and the policies for 1 funder (Patient-Centered Outcomes Research Institute) were updated during the 4 months between funder contacts. 16 As the research enterprise accepts the idea that making individual participant data available for further research fulfills an ethical obligation to trial participants, 17 and is something participants generally support, 18 scientists can turn their focus to clarifying minimal requirements for ensuring anonymity, appropriate use according to informed consent, and data sharing (eg, including making analytic code and other key resources available). A research culture that readily shares and reuses research data will be better positioned to more fully support the scientific imperatives of replication and reproducibility. 6

Limitations
This study had several limitations. The findings may underrepresent some funders' activities since