NHS research authority links approval of trials to registration and publication of results

Campaigners for transparency of all clinical trial data have welcomed plans set out by the body that oversees research standards in the NHS for the registration of trials and the publication of their results.

The new commitments from the NHS Health Research Authority follow a meeting of stakeholders held on 25 April.1 The proposals include granting ethics approval for clinical trials from September 2013 only to researchers who have agreed a timeframe to register their trial.

The authority was set up in December 2011 to promote and protect the interests of patients in health research. It has said that it would work with research funders and sponsors to set standards for the publication and dissemination of research outcomes and that researchers would have to agree to abide by these before a study could go ahead.

It also wants to set standards on communicating the results of studies to their participants.

In terms of researchers withholding results, the authority said that it would work with regulators of professions to tackle this type of misconduct. It also said that there was work to be done with publishers to dispel misperceptions about the difficulties of publishing results.

The authority is a signatory to the AllTrials campaign (alltrials.net) that calls for all trials to be registered and all results reported and for full transparency of research data,2 and it publishes a summary and opinion on research projects that come before its ethics committees.

Janet Wisely, the authority’s chief executive, said, “Change will only come through determined leadership; and with the commitment of our partners to increasing openness we are now sharing our plans for promoting transparency in a robust and sustainable way.

“We have also been mindful of our ambition to make it easier to do good quality research in the UK and have set out sensible and proportionate measures that will increase transparency and increase confidence in health research in the UK.”

Ben Goldacre, of the AllTrials campaign, said, “We have known for decades that the results of clinical trials are routinely withheld in medicine. This is one of the most important ethical and practical problems facing medicine today. Some have tried to hide from it: the HRA is demonstrating clear leadership, with impressive and solid practical suggestions. I hope that all in medicine will give the HRA their wholehearted support.”

Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry, commented, “We support the HRA’s aim to promote transparency in clinical research as a means of furthering public understanding of research. We are also encouraged by the recognition that any initiatives developed in the UK should not be detrimental to our international standing as a leader in health research. We look forward to working with the HRA in the months to come as they develop their proposals into practical measures.”