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Towards transparency: adoption of WHO best practices in clinical trial registration and reporting among top medical research funders in the USA
  1. Elise Gamertsfelder1,2,
  2. Netzahualpilli Delgado Figueroa3,
  3. Sarai Keestra4,
  4. Alan Rossi Silva5,
  5. Ronak Borana6,
  6. Maximilian Siebert7,
  7. Till Bruckner2,8,9
  1. 1 Department of Health Policy, The London School of Economics and Political Science, London, UK
  2. 2 Consilium Scientific, London, UK
  3. 3 Department of Medicine, University of Guadalajara, Guadalajara, Mexico
  4. 4 Department for Epidemiology & Data Science, University of Amsterdam, Amsterdam, The Netherlands
  5. 5 Faculty of Law, Rio de Janeiro State University, Rio de Janeiro, Brazil
  6. 6 XLRI, Jamshedpur, India
  7. 7 Meta-Research Innovation Center at Stanford, Stanford University, Stanford, California, USA
  8. 8 TranspariMED, Bristol, UK
  9. 9 UiT The Arctic University of Norway, Tromsø, Norway
  1. Correspondence to Elise Gamertsfelder, Department of Health Policy, The London School of Economics and Political Science, London WC2A 2AE, UK; emgamert{at}


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.

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  • 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.