In a recent article published by the Journal of the American Medical Association (JAMA) Bauchner et al, reflect on the ethical obligations and scientific necessity of clinical trial data sharing. Experiences with data sharing are beginning to be published and although requests for data access have been low so far, this number will undoubtedly increase with time.

The principle reasons for data sharing include making sure that all data are available for reanalysis and meta-analysis. This will discourage the publication of incomplete or misleading results and ensure that trial protocols and analysis plans have been adhered to. The authors, however, believe that the most persuasive argument for data sharing surrounds accountability to those enrolled on the studies. The International Committee of Medical Journal Editors (ICMJE) has recently stated that “there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk”. Although patients cannot expect to be rewarded for participation, there is a duty to society for the study investigators to make the most out of the trial data. Bauchner et al, maintain that the contract between trial operator and patient is violated if data are not maximised or incompletely analysed. They claim that “the absence of data sharing therefore constitutes a failure of the obligation of researchers to the study participants, and therefore a failure of the ethical underpinnings of conducting clinical trials.” The authors go on to identify three areas that need attention before a successful data sharing system is achieved:

• Effective deidentification of the participants and an understanding by the patients that their deidentified data may be shared is vital.
• An efficient and operational data sharing scheme must be put in place.
• The role of the original trial investigators and sponsors must be acknowledged and respected.

In order for data sharing to be embraced and implemented the associated system must be fair, cost-effective and proven to be fit for purpose while ensuring that it realises the moral responsibilities to all patients involved in the study.

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Summary by Jo Chapman, PhD from Aspire Scientific.