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

Clinical trial funders can promote transparency and prevent publication bias through clear policies.^1-3 In a May 2017 World Health Organization (WHO) joint statement, funders pledged to develop policies, within 1 year of signing, that will require funded trials to be registered and reported, and improve individual patient data (IPD) sharing.⁴ We assessed trials transparency policies from a sample of noncommercial funders in these domains.

We examined the top 20 noncommercial funders of health research globally, by 2013 expenditure,⁵ against a reference standard aligned to the WHO joint statement: that all trials should be registered, summary results made available via publication or trial registries, and IPD reasonably made available whenever possible.^3,4

We created audit questions that we then used to assess funders’ publicly accessible policies against these reference standards, focusing on (1) the presence of a clear policy for each area; (2) whether adherence on summary results and IPD sharing was required, or addressed only with supportive language (acknowledging the importance of the standard but not requiring consistent adherence); (3) how funders assessed trialists’ adherence; and (4) whether adherence audits were publicly available. Open access policies were not considered as results sharing policies. Table 1 shows WHO policy elements and our audit questions; no external validation was done on the audit questions.

Two researchers searched funder websites and Google from February 2017 through April 2017. Non-English material was reviewed using Google Translate. Additionally, native speakers were recruited to conduct supplemental non-English searches. Policies were extracted, assessed, and stored verbatim. Disagreements were rectified unanimously.

Funders were emailed with findings during May-June 2017 and given 6 weeks to respond, on the record, to whether they “agree[d] with our characterisation of your organization’s policies.” Nonresponders were contacted 2 more times. Descriptive statistics were generated summarizing the policies.

Eighteen funders were included, as 2 stated they do not fund trials. Nine funders (50%) required all trials to be registered, 8 (44%) required all summary results reported, 4 (22%) provided specific timelines for sharing summary results, and 2 (11%) required IPD sharing. Only 2 funders (11%) had a requirement covering all domains (Table 2). Six funders (33%) offered technical or financial resources to support IPD sharing.

Some funders had a policy that did not require adherence in all instances, or contained only supportive language rather than a clear requirement. Overall, 7 funders (39%) met this lower criteria for sharing summary results, and 9 (50%) for IPD.

Monitoring of trialists’ adherence was described by 7 funders (39%) for registration; 6 (33%) for summary results sharing; and 6 (33%) for IPD sharing. Some funders described how they monitored adherence without mandating sharing. No funder proactively shared any adherence audit. Fourteen funders (78%) responded to follow-up; 6 of 252 data points (2%) were revised in response to funder feedback.

Clinical trial transparency policies of noncommercial funders varied greatly. Most funders did not require grant recipients to register all trials, share all trials’ summary results, and share IPD. Internal procedures for monitoring adherence were poorly described, and no funder had a clear policy to disclose adherence data. As of February 2018, 6 assessed funders have signed the WHO joint statement and therefore pledged to incorporate WHO’s proposed policy elements during the coming months.

Previous narrative descriptions covering smaller samples of noncommercial sponsors’ policies, which focus broadly on transparency and resource allocation in research, are consistent with these findings.^2,6 An audit of top pharmaceutical companies found more comprehensive policies requiring all trials to be registered (91%), summary results reported (96%), and IPD shared (96%).³

This study has limitations. The sample contained only 18 funders; however, these accounted for $41 billion in 2013 health care research spending.⁵ No validation of audit questions was conducted; however, the questionnaire was simple and aligned largely to WHO’s joint statement. Policies were examined rather than performance. Future work should include ongoing monitoring of changes to funders’ policies and adherence to these policies by trialists, as recommended by WHO.

Accepted for Publication: February 26, 2018.

Corresponding Author: Ben Goldacre, MBBS, EBM Datalab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, United Kingdom (ben.goldacre@phc.ox.ac.uk).

Author Contributions: Dr Goldacre had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: DeVito, Goldacre.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: DeVito, Goldacre.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: All authors.

Obtained funding: Goldacre.

Administrative, technical, or material support: All authors.

Supervision: Goldacre.

Conflict of Interest Disclosures: All authors have completed the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Goldacre has received research funding from the Laura and John Arnold Foundation, Wellcome Trust, the National Health Services National Institute for Health Research School of Primary Care Research, Oxford Biomedical Research Centre, the Health Foundation, and the World Health Organization; he also receives personal income from speaking and writing for lay audiences on the misuse of science. Mr DeVito and Ms French report receiving grant funding from the National Institute for Health Research and Wellcome Trust to their institution and being employed on Dr Goldacre’s grants from the Laura and John Arnold Foundation and the Health Foundation.

Funding/Support: This work was funded by a grant from the Laura and John Arnold Foundation.

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Additional Contributions: We thank Kerstin Frie, MSc (University of Oxford), Maria Vazquez Montes, PhD (University of Oxford), Philippe Ravaud, MD, PhD (Inserm U1153), Rossella Salandra, MEng (Imperial College London), Yaling Yang, PhD (University of Oxford), and Naohiro Yonemoto, MPH (Yoshidakonoe, Kyoto University), for their voluntary assistance in conducting non-English language policy searches. No compensation was provided for their assistance.

Additional Information: All underlying data, including data on all individual funders, are available at https://figshare.com/s/276f9dc0b37d8ecd0ab0.