AllTrials response to EMA consultation on access to clinical trial data

27th September 2013

It’s important that the European Medicines Agency hears from lots of different voices in support of their good proposals on sharing clinical trial data. So please send them something, even something short. Below is the summary of our response. Please feel free to borrow from this for your response. Remember that the deadline for responses is this Monday 30th September 2013. Read the EMA’s policy paper and how to respond to it here.

The AllTrials campaign is an initiative of Bad Science, BMJ, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS and Sense About Science and is being led in the US by Dartmouth’s Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice. It was launched in January 2013 to call for all clinical trials to be registered and results reported.

Clinical trials are investigations designed to assess the effects – wanted and unwanted – of healthcare interventions in people. The Declaration of Helsinki, which is the World Medical Association’s statement of principles for medical research involving people, states that every investigator running a clinical trial should register it and report its results. Millions of volunteers have participated in clinical trials to help find out more about the effects of treatments on disease, yet that important ethical principle about reporting has been widely ignored. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated.

This is what led to the AllTrials campaign, which is now supported by 57,700 people and over 400 organisations worldwide, including research funders, regulatory bodies, consumer organisations, medical Royal Colleges, professional and learned societies, journals, pharmaceutical company GSK and more than 200 patient groups.

We support the European Medicines Agency’s aim to ensure full access to clinical trial information the Agency holds. We believe that if data is submitted to support a marketing authorisation for a medical product in Europe then this data should be available for scrutiny by researchers. We agree that the EMA has a role to play in the dissemination of this data.

We welcome the EMA’s proposal to proactively publish clinical study reports from clinical trials submitted in support of a marketing authorisation application. Clinical study reports contain a large amount of detailed information about the methods, analysis, results and conclusions of a clinical trial, information which is needed to make and to scrutinise decisions about medicines and to assess published summary findings. This information should be publicly available. Individual patient data in a report can be redacted and should be available on request to researchers with a commitment that no reasonable request will be refused.

We support the EMA’s policy that in general the data included in clinical trial study reports should not be considered commercially confidential once a marketing authorisation has been granted or the decision making process on an application for marketing authorisation is complete.

There is no good reason to delay full reporting of clinical trial results. It will have huge benefits for patients, health workers, doctors, pharmacists, regulators and researchers. It will benefit treatment decisions now and research into future options. We urge the EMA to implement its new policy as soon as possible.

Link to our detailed response (PDF)