Saturday, June 01, 2013

AllTrials contd. - D Day for comments - June 10th


The Health Research Authority (HRA) has today outlined plans for how it will play a leading role in ensuring clinical and other health research findings are published Transparency in health research has long been a subject of debate; recently, the House of Commons Science and Technology Committee has launched an enquiry into Clinical Trials and the high-profile Alltrials campaign has attracted tens of thousands of signatures. The HRA has an established role to promote transparency, and already publishes research study summaries and the opinions of its Research Ethics Committees (RECs). On 25 April, the HRA led a stakeholder workshop, at which it made, with the full support of its partners, a number of commitments, which are now being sent out for further comment.

These include proposals:
 To make the registration of clinical trials within an agreed timeframe a condition of REC approval from September 2013.
 To work with research funders and sponsors to set standards for the publication and dissemination of research outcomes.
 To develop mechanisms to actively review plans for publication against these standards and include them specifically within the condition of the REC approval.
 To develop simple mechanisms to monitor compliance with REC approved plans to publish  To set standards and issue guidance for how those that have participated in research are appropriately informed of individual outcomes and study results at the end
 To work with regulators of professions to address the misconduct of withholding results.
 Work with publishers to dispel the myths and perceptions about the difficulties in publishing results.

The HRA will work with partners to turn these commitments into actions, and welcomes further views on the plans.

Welcoming the paper, Janet Wisely, HRA Chief Executive, said “We have long supported the sharing of all health research findings, have already signed up to the petition and publish a summary and the research opinion for research projects which come before our Research Ethics Committees. We have encouraged wider debate on the subject through our Stakeholder Forum in February and our recent workshop with representatives of patient-facing organisations, researchers and industry. 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, 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 are demonstrating clear leadership, with impressive and solid practical suggestions. I hope that all in medicine will give the HRA their wholehearted support”.

Iain Chalmers, Coordinator of the James Lind Initiative added 'The HRA's paper 'Transparent Research' is evidence of a welcome ambition to improve research registration, publication, data access and participant information. I endorse the HRA's approach and urge researchers, research participants and the public in general to support the HRA's proposals.’

Simon Denegri, Chair of INVOLVE, added 'I very much welcome this robust and comprehensive statement of intent by the HRA to improve research transparency. Past and future participants in research studies should be encouraged by the firm commitment to look at this agenda from a public and patient angle. In particular, the emphasis on providing the right information in the right way and at the right time has an important bearing on people's access to, and willingness to take part in, research. I look forward to working with the HRA in taking these recommendations forward and ensuring that there is strong public involvement in their development.'

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