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

Abstract

This study summarizes policies of the top 20 noncommercial funders of health research regarding trial registration, access to summary results, and individual patient data availability.

Clinical trial funders can promote transparency and prevent publication bias through clear policies. 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. We assessed trials transparency policies from a sample of noncommercial funders in these domains.

Methods

We examined the top 20 noncommercial funders of health research globally, by 2013 expenditure, 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.

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.

Table 1. 2017 WHO Joint Statement Common Policy Elements and Audit Questions Used to Assess Trial Transparency Policies of Noncommercial Funders of Clinical Trials.

	Policy Domain
	Trial Registration	Summary Results Sharing	IPD Sharing
WHO Joint Statement Common Policy Elements	Before any clinical trial is initiated (at any phase) its details must be registered in a publicly available, free-to-access, searchable clinical trial registry complying with WHO’s international agreed standards.	We jointly agree that summary results of clinical trials should be made publicly available in a timely manner following primary study completion. There are 2 main modalities for this to occur. By posting to the results section of the clinical trial registry and by journal publication. We will work towards a timeframe of 12 months from primary study completion as the global norm for summary results disclosure.	The benefit of sharing IPD and the facilitation of research through greater access to primary datasets is a principle, which we consider important.... We will continue to engage with partners in support of an enabling environment to allow data sharing to maximize the value of health research data. We will support activities that enable the development of explicit ethical and legal frameworks that govern data collection and use and enable development of international norms and standards for sharing of IPD from clinical trials.
Study Questions
Do they have a policy at all?	Yes/No	Yes/No (excluding any open access policies)	Yes/No
Do they require…	… all trials to be registered? Yes/No	… all summary results to be made publicly available? (Yes/Supportive Statement/No)	… IPD from all trials to be made available (within reason)? (Yes/Supportive Statement/No)
Do they…		… give a timeline within which a result must be reported after completion? Yes/No	…explicitly provide additional technical or financial resources to support IPD sharing? Yes/No
Do they describe how they internally monitor adherence?	Yes/No	Yes/No	Yes/No
Do they publish anything publicly on their audit of adherence?	Yes/No	Yes/No	Yes/No

Abbreviations: IPD, individual participants’ data; WHO, World Health Organization.

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.

Results

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.

Table 2. Summary Results of Audit of Trial Transparency Policies of Noncommercial Funders of Clinical Trials.

Noncommercial Fundera	Responder to Outreach	Trial Transparency Policiesb
		Trial Registration			Summary Results Sharing				IPD Sharing
		Has Policy	Policy Requires Registration	Conducts Internal Audit	Has Policy	Policy Requires Sharing	Specifies Timeline for Results Sharing	Conducts Internal Audit	Has Policy	Policy Requires Sharing	Offers IPD Sharing Support	Conducts Internal Audit
NIH United States	Yes	Yes	Yes	Yes	Yes	Yes	1 y	Yes	Yes	Supportive	Yes	Yes
EC Europec	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes	Yes	Supportive	Yes	Yes
MRC United Kingdom	Yes	Yes	Yes	Yes	Yes	Yes	No	No	Yes	Yes	Yes	Yes
Inserm France	No	No	No	No	No	No	No	No	No	No	No	No
US DoDc	Yes	Yes	No	No	Yes	Supportive	No	Yes	Yes	Supportive	Yes	No
Wellcome Trust United Kingdom	Yes	Yes	Yes	Yes	No	Supportive	No	No	Yes	Supportive	Yes	Yes
CIHR Canada	Yes	Yes	Yes	Yes	Yes	Yes	No	No	Yes	Supportive	No	No
NHMRC Australia	Yes	Yes	Yes	No	Yes	Supportive	No	No	Yes	Supportive	No	No
DFG Germany	Yes	Yes	Yes	Yes	Yes	Yes	2 y	Yes	Yes	Yes	Yes	No
NSFC China	No	No	No	No	No	Supportive	No	No	No	No	No	No
CNRS France	No	No	No	No	No	Supportive	No	No	No	No	No	No
NIHR United Kingdom	Yes	Yes	Yes	Yes	Yes	Yes	1 y	Yes	Yes	Supportive	No	Yes
JSPS Japan	Yesd	No	No	No	Yes	Yes	No	Yes	No	No	No	No
BMBF Germany	Yes	Yes	Yes	No	Yes	Yes	2 y	No	No	Supportive	No	No
Gates Foundation United States	Yes	No	No	No	Yes	Supportive	No	No	Yes	Supportive	No	Yes
MoH Italy	Yesd	No	No	No	No	No	No	No	No	No	No	No
ISCIII Spain	Yes	No	No	No	No	Supportive	No	No	No	No	No	No
MoH China	No	No	No	No	No	No	No	No	No	No	No	No
Total, No. (%)	14 (78)	10 (56)	9 (50)	7 (39)	11 (61)	Yes 8 (44) Support 7 (39)	4 (22)	6 (33)	10 (56)	Yes 2 (11) Support 9 (50)	6 (33)	6 (33)

Abbreviations: BMBF, Federal Ministry of Education and Research; CIHR, Canadian Institute of Health Research; CNRS, National Centre for Scientific Research; DFG, German Research Foundation; DoD, Department of Defense; EC, European Commission; Inserm, National Institute of Health and Medical Research; IPD, individual patient data; ISCIII, Carlos III Health Institute; JSPS, Japanese Society for the Promotion of Science; MoH, Ministry of Health; MRC, Medical Research Council; NHMRC, National Health and Medical Research Council; NIH, National Institutes of Health; NIHR, National Institute of Health Research; NSFC, Natural Science Foundation China.

^aFollowing outreach, 2 funders (Howard Hughes Medical Institute and Japanese Science and Technology Agency) were excluded from further analysis because they did not directly fund any clinical trials.

^bThe question “Do they publish anything publicly on their audit of adherence?” was omitted from the Table because the response was “No” for all funders across all domains.

^cSome organizations fund research though a number of independent bodies. In these instances, the policies of the largest granting body were examined. For the purposes of this study, the EC is represented by the Horizon 2020 program and the US DoD is represented by the Congressionally Directed Medical Research Program.

^dResponded to outreach but did not provide substantive feedback.

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.

Discussion

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. 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%).

This study has limitations. The sample contained only 18 funders; however, these accounted for $41 billion in 2013 health care research spending. 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.

Section Editor: Jody W. Zylke, MD, Deputy Editor.