Transparency and reporting of clinical trials in the UK

International Clinical Trials Day is celebrated around the world on the 20 May to commemorate the day in 1747 when James Lind started one of the very first trials in history. It provides an opportunity to raise awareness about the importance of clinical research in healthcare and to encourage involvement in clinical trials. It is timely that the recently created Health Research Authority (HRA) – whose mission is ‘to protect and promote the interests of patients and the public in health research’ – has announced its plans to increase transparency and reporting of clinical trials in the UK.

BioMed Central welcomes the HRA proposals ‘to make the registration of clinical trials within an agreed timeframe a condition of ethics approval’ and ‘to work with publishers to dispel the myths and perceptions about the difficulties in publishing results’.

Services for trial registration are already widely available. Under the aegis of the World Health Organization which has developed standards for trial registration, a growing number of registers worldwide help researchers reduce wasteful duplication of research and the potential for patients to be put at unnecessary risk in redundant trials.

In the absence of national legislation that would mandate public registration, responsibility for registration and results reporting ultimately lies with investigators and their sponsors or employers. A growing number of health research funders make public registration a condition of their grant application process. Ethical approval is another stage in the research cycle where public registration could be mandated and the HRA proposal to that effect is a step in the right direction.

BioMed Central has acknowledged that public registration (declaration of existence of research) can be seen as the first step towards transparency and future dissemination of health research outcomes. We administer the ISRCTN trial register which will list both trials awaiting ethical approval and trials with full ethical approval.

Traditional subscription journals often need to be extremely selective about what they can publish and less exciting results from trials can be excluded for reasons of space. Open access journals do not have these space constraints: BioMed Central journals welcome the publication of negative or inconclusive results which are essential in order to get the full picture of the research which has been carried out in any specific field. We publish a number of trials-related journals, including Trials, Systematic Reviews and the Journal of  Negative Results in BioMedicine which focuses on articles that ‘promote the discussion of unexpected, controversial, provocative and/or negative results in the context of current tenets’. The journal BMC Research Notes aims ‘to reduce the loss suffered by the research community when results remain unpublished because they do not form a sufficiently complete story to justify the publication of a full research article’. All journals in the BioMed Central medical portfolio encourage and/or demand adherence to established guidelines on trial reporting, such as CONSORT for trial results, SPIRIT for trial protocols, PRISMA for systematic reviews.  They all require that authors register their trials in a recognised register and provide the relevant reference, whether it is the ISRCTN number or the trial identifier used by another of the WHO-vetted registers.

BioMed Central supports this announcement and we look forward to working with the HRA.

Posted on behalf of Helene Faure

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