Towards transparency: adoption of WHO best practices in clinical trial registration and reporting among top medical research funders in the USA

Abstract

ObjectiveTo 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.MethodsPublic 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.ResultsFourteen 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.ConclusionsThere 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.

Current policies of non‐commercial funders towards transparency in clinical trials

“…Recently, Buckner and colleagues have published three reports [20][21][22] on how the most important non-commercial funders of medical research comply with the 11 WHO Joint Statement best practices-regardless of whether they were signatories to the WHO Joint Statement.…”

“…These funders had a combined annual budget of US$47 billion-although the vast majority belonged to the NIH (US$41.4 billion). 22 Open access publishing was requested by all 14 funders, whereas preregistration was required by 9 (64%). Publicly availability of funders' monitoring outputs and inclusion of the trial identification number in all publications were requested by only two (14%) funders 22 (Table 1).…”

“…The third report evaluated in 2022 14 US public and philanthropic funders with an annual budget on medical research> US$50 million. These funders had a combined annual budget of US$47 billion—although the vast majority belonged to the NIH (US$41.4 billion) 22 . Open access publishing was requested by all 14 funders, whereas preregistration was required by 9 (64%).…”

“…are non‐binding). For example, the FDA and PCORI have 4 and 2 of this type of practices, respectively 22 …”

Reporting health and medical research

“…Author adherence and journal endorsement of reporting guidelines has improved over time 15. Some funders such as the Patient-Centered Outcomes Research Institute have also begun recommending use of reporting guidelines 16. However, despite increasing recognition and endorsement, overall adherence and completeness of reporting remains insufficient 17–19.…”