We worked with the MHRA to develop proposals to improve and strengthen clinical trial legislation in the UK. The MHRA has now published a consultation on the proposals. Our Head of Policy and Engagement, Naho Yamazaki, blogs on how the proposals can help to make the UK the best place to research and develop safe and innovative medicines.
Dr Naho Yamazaki, Head of Policy and EngagementOne proposal is to make research transparency a legal requirement. We know that transparency is a fundamental part of good science. Transparency helps improve the quality, impact, and reach of research and reduces avoidable waste and duplication. It makes it possible for meaningful patient and public involvement. Transparency allows the public to see what research is taking place or has completed, and access information about the results. Ultimately transparency is necessary to build public trust and accountability in research. For all these reasons we support the proposals to build transparency into law.
How can research be more transparent?
Research transparency falls into four pillars. These are:
- registration: making it public that a study has started.
- reporting results: making it public what the study has found
- informing participants: letting those who took part know what the study has found
- sharing study data and tissue: enabling further research
The Make it Public strategy sets out what we expect and what we plan to do to embed transparency across the research system. Legislation will be an important step to help us meet the vision that trusted information about health and social care research studies is publicly available for the benefit of all.
The legislation
We know from the consultation that led to the Make it Public strategy that there is wide support for increased transparency among the research community. However, current legislation is silent on the key actions that are needed to create a truly transparent research environment.
To address this the MHRA proposes to build some of the provisions, policies and processes set out in the Make it Public strategy into legislation. If taken forward, this would ensure that research transparency is embedded in the regulation of all clinical trials in the future.
The consultation asks you to comment on whether legislation should include a requirement to register a trial, if there should be a requirement to publish a summary of results within 12 months of the end of the trial, and if there should be a legal requirement to share trial findings with participants (or explain why this is not appropriate).
How can you have your say?
You can read more about these proposals and the others put forward on the Gov.uk website. Responses to the questions are via an online form. The proposals are open to public consultation until 11pm on 14 March. Responses to the consultation will be used to help develop the legislation that will be put to the UK Parliament, to become law.