Last month evidence for the effectiveness of another widely-prescribed drug was found wanting after sleuthing researchers gathered unpublished data to include in a systematic review and meta-analysis – a staggering 74% of patient data was not previously published. The grave consequences of, and motivations for, distortions of clinical evidence are many – and widely discussed – but what should we do to tackle the underlying issues?

The journal Trials has, since its launch, sought to provide leadership in communicating about clinical trials and has published a number of articles that provide practical guidance and recommendations on overcoming barriers to sharing clinical research data. This week, the journal launches an ongoing thematic series on ‘Sharing clinical research data’, edited by Associate Editor Andrew Vickers.

The guidance and recommendations include a code of conduct for data sharing and re-use, and recommendations for funders and ethics committees to increase raw data availability, published last year.

In January 2010 editors of Trials took this initiative further by producing guidelines for authors, editors and peer reviewers on sharing trial data while protecting patient privacy, which have also been adopted by the BMJ, and latterly put into practice in the peer-reviewed literature, albeit by one of the guidelines’ authors. Nevertheless, Trials too is now receiving trial data set-driven pre-submission enquiries and we look forward to working with more authors willing to publish novel, re-usable trial data. We will be defining explicit clinical ‘Data Note’ instructions for authors for the journal, in conjunction with our early-adopting colleagues.

Protecting patients is essential to clinical research, including an individual’s right to privacy, and legislation has a vital part to play. But conversely, in the latest addition to the series, lawyer James D Miller explains how the requirements of the US Health Insurance Portability and Accountability Act (HIPAA) and the Privacy Rule may in fact be stifling research by limiting the sharing of final research data – sharing is increasingly a requirement of research funding-agencies such as the National Institutes of Health.

Bian and Wu, in their May commentary, called for legislation to ensure sharing of clinical trial data.  As the recent reboxetine case so staunchly reminds us, lack of access to trial data, whether via publication or in a restricted fashion, can also harm patients, arguably more so than the potential for invasion of privacy.

The sharing of data continues to be a key issue for BioMed Central and Trials – a journal that strives to be a force for change and innovation in publishing – and this article series remains open to new contributions on this topic.

Readers will note the articles so far published span the volumes since Trials’ launch in 2006. While we may not be entirely satisfied with the pace of change, the potential benefits to science and human health warrant continued commitment.

Dr Andrew Vickers – Associate Editor, Trials
Iain Hrynaszkiewicz – Associate Journal Publisher, BioMed Central