HRA consultation on Clinical Trials Transparency

Today, the Academy responds to the Health Research Authority’s (HRA) ‘Make it public’ consultation on clinical trials transparency.

We welcome the HRA’s efforts to promote greater transparency, and support steps to improve reporting and monitoring of clinical trials. Progress in these areas will likely bring meaningful benefits to patients and the public.

However, we call for new regulation to be followed by support and incentives for researchers, so carrying out clinical trials remains a rewarding activity that showcases and encourages best practice.

The HRA’s ‘Make it public’ consultation is likely to see new regulation for the sector, aimed at better reporting, monitoring and feedback of clinical trials research, and more transparency across the discipline.

The Academy has previously called upon the scientific community to take greater responsibility for openness and transparency in research. Our reports on ‘Research reproducibility’ and  'Sources of evidence for safety, efficacy and effectiveness of medicines' , highlighted the need for transparency and its benefits to UK research.

In the case of clinical trials, the dangers of non-transparency are arguably highest. Not least, under-reporting can cause avoidable harm to patients and waste limited healthcare and research resources.

The four key points we ask the HRA to consider in its strategy, to increase transparency and make compliance easier, are:

• Limit any increase in the administrative burden on the researcher’s already limited time, and encouraging compliance with additional support and incentives for researchers (e.g. extra resource in funding packages and rewards for good practice).
• Ensure any sanctions introduced are appropriate and well targeted, and do not unfairly penalise compliant researchers or justifiable non-compliance. Inappropriate sanctions, such as fines, may unintentionally weaken UK research.
• Build closer collaboration between the regulatory bodies, journals and funders to ensure clear expectations for researchers and the reduction of conflicting requirements or barriers to compliance.
• Ensure registration and reporting systems are compatible and encourage comprehensive, up-to-date entries to avoid duplicating information between systems and unnecessary costs.

We welcome the opportunity to comment on the HRA’s draft vision, alongside the series of workshops it is hosting across the UK. The Academy will continue engaging with efforts to improve research transparency and encourage others in the community to also participate in shaping this important strategy.

The Academy’s full response can be downloaded on the right hand side of this page.

More information and the full report on research reproducibility can be found on our dedicated policy page. Further information and a full report our sources of evidence for assessing efficacy, safety of medicines work can be found here.