Major US funders ($$ billions) are pushing for greater clinical trials transparency

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

2019 Study Key Points

  • Question
    What are the current policies for clinical trial registration, summary results sharing, and individual patient data sharing among the top 10 noncommercial US health research funders?
  • Findings
    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. However, fewer US funders require specific transparency actions in these domains (11%-56%) or monitor compliance with their policies (56%-67%).
  • Meaning
    More work remains to be done to ensure timely implementation and enforcement of clinical trial transparency initiatives to reduce waste and realize public value from clinical research investments.

Abstract

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.

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.

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.

 

Author: DES Daughter

Activist, blogger and social media addict committed to shedding light on a global health scandal and dedicated to raise DES awareness.

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