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New rules from the HRA to ensure registration and publication of clinical trials

The Health Research Authority has published plans to ensure researchers register trials and publish the findings for others to learn from.

Background

Clinical trials are an essential step in turning a discovery in a lab into a treatment for patients. New drugs must go through a series of controlled tests to ensure they are safe and effective. Clinical trials, involving healthy volunteers or patients, help us establish whether a drug is safe and how well it works. This POSTnote gives a great overview of clinical trials. 41 of our member charities are currently funding clinical trials either individually or in collaboration with industry, other charities or public funders.

Patients want the opportunity to be involved in trials of new treatments. They do this both in the hope that the treatment will benefit them, but also altruistically to improve treatment for others in the future. Transparency about how these trials are conducted and the publication of the results is central to research, helping other researchers to learn from this information and make further advances. As well as the overall results of the trial, the detailed data gathered are very valuable for researchers.

The All.Trials campaign launched in 2013 to to call for action to ensure all trials past and present, for all drugs in current use, are registered; and that the full methods and the results are reported.

AMRC supported this campaign and this briefing gives more background on best practice for AMRC members and the legislative requirements in this area. We are now working with other research funders to promote transparency.

What are the new rules for researchers?

From 30 September 2013, researchers will have to register their clinical trial in a publicly accessible database within six weeks of recruiting the first patient to take part. Without this, their application will not be approved to go ahead by the HRA's Research Ethics Committees.

This will apply to all clinical trials of:

  • an investigational medicinal product
  • a medical device
  • an investigational medicinal product and an investigational medical device
  • a novel intervention or randomised clinical trial to compare interventions in clinical practice

For other studies considered by the HRA, they will ask applicants about their plans for registration and the Research Ethics Committees will consider these.

The HRA is also changing their applicant and sponsor declaration to encourage publication of results by requiring applicants to declare that previous studies have been registered and published.

What next?

Earlier this year the Wellcome Trust convened a workshop to discuss steps to promote transparency in clinical research. A list of actions were drawn up from this. These are now being taken forward by different partners including professional bodies, journals, regulators, funders and registries.

As research is international and takes place all around the world, any solutions to improve transparency have to be global. Conversations are underway between international registeries to explore how they can be made interoperable at an international level, including giving trials one single identifier, and allowing information about the trial to be uploaded. This might include a lay summary and details of the study protocol, and potentially the trial results when complete.

Work is also underway to explore how the underlying patient-level data from a trial on which the findings are based, can be made accessible for re-analysis by other researchers. GlaxoSmithKline has developed a model to do this and other companies funding research are exploring similar solutions. Public funders are also looking at a system to enable safe and secure access to these data; research is underway to better understand the value of accessing these data to inform the design of such a system.

The European Medicines Agency is currently consulting on its draft policy aiming to improve transparency; we will be responding.

The All.Trials campaign is continuing to maintain the momentum of these discussions and organising meetings to develop practical solutions, including a planned meeting of patient groups to discuss what information patients want when they are choosing whether to take part and taking part in research.