Article Text
Abstract
Objective To assess to what extent the clinical trial policies of the largest public and philanthropic funders of clinical research in the United States meet WHO best practices in trial registration and reporting.
Methods Public and philanthropic funders of clinical trials in the USA with >US$50 million annual spend were selected. The funders were assessed using an 11-item scoring tool based on WHO Joint Statement benchmarks. These 11 items fell into 4 categories, namely: trial registration, academic publication, monitoring and sanctions. An additional item captured whether and how funders referred to Consolidated Standards of Reporting Trials (CONSORT) within their trial policies. Each funder was independently assessed by two or three researchers. Funders were contacted to flag possible errors and omissions. Ambiguous or difficult-to-score items were settled by an independent adjudicator.
Results Fourteen funders were assessed. Our cross-sectional study found that, on average, funders have only implemented 4.1/11 (37%) of WHO best practices in clinical trial transparency. The most frequently adopted requirement was open access publishing (14/14 funders). The least frequently adopted were (1) requiring trial ID to appear in all publications (2/14 funders, 14%) and (2) making compliance reports public (2/14 funders, 14%). Public funders, on average, adopted more policy elements (5.2/11 items, 47%) than philanthropic funders (2.8/11 items, 25%). Only one funder’s policy documents mentioned the CONSORT statement.
Conclusions There is a significant variation between the number of best practice policy items adopted by medical research funders in the USA. Many funders fell significantly short of WHO Joint Statement benchmarks. Each funder could benefit from policy revision and strengthening.
- policy
- drug development
- health care quality, access, and evaluation
Data availability statement
Data are available in a public, open access repository. https://github.com/egamertsfelder/TrialTransparency2023/tree/main.
Statistics from Altmetric.com
Data availability statement
Data are available in a public, open access repository. https://github.com/egamertsfelder/TrialTransparency2023/tree/main.
Footnotes
Twitter @NetzaDelgado, @TranspariMED
Contributors EG is responsible for the overall content as guarantor. TB and EG were involved with the study’s conception and design. Policy analysis was completed by EG, NDF, SK, ARS, RB and MS. The initial draft was authored by EG with assistance from TB. All authors contributed significantly to revisions.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests SK and ARS both belong to the Universities Allied for Essential Medicines (UAEM) and the People’s Health Movement on a voluntary basis. TB is the founder of TranspariMED.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.