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.