TY - JOUR
T1 - Towards transparency
T2 - Adoption of WHO best practices in clinical trial registration and reporting among top medical research funders in the USA
AU - Gamertsfelder, Elise
AU - Delgado Figueroa, Netzahualpilli
AU - Keestra, Sarai
AU - Silva, Alan Rossi
AU - Borana, Ronak
AU - Siebert, Maximilian
AU - Bruckner, Till
N1 - Funding Information: Federally funded studies are subject to additional requirements for data collection and dissemination. Grantees funded by any Department of Health and Human Services agency, including the NIH, FDA and Agency for Healthcare Research and Quality (AHRQ), must register and submit ACT results as a condition for continued and future funding. Complementary to this, the NIH issued a dissemination policy that covers all NIH-funded trials, not just ACTs. However, as found in this and several other studies, legal requirements, ethical considerations and reality do not always coincide. Notably, federally funded studies were found to be significantly less likely to adhere to FDAAA mandates than industry-sponsored trials. NIH-funded studies are reported within 12 months of study completion just 8% of the time, while other federally funded studies have a 12-month results reporting rate of 5.7%. Publisher Copyright: © Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - drug development
KW - health care quality, access, and evaluation
KW - policy
UR - http://www.scopus.com/inward/record.url?scp=85177566742&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjebm-2023-112395
DO - https://doi.org/10.1136/bmjebm-2023-112395
M3 - Article
C2 - 37932014
SN - 2515-446X
JO - BMJ evidence-based medicine
JF - BMJ evidence-based medicine
M1 - bmjebm-2023-112395
ER -