New debate has recently arisen on the subject of access to clinical trial data, and the current limited availability has been deemed ‘neither desirable or realistic’ by a group of leading European drug regulators. The officials who have highlighted their sentiments on selective publication of clinical trials data are from the European Medicines Agency (EMA), France’s Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Dutch Medicines Evaluation Board (CBG-MEB), and they have joined the debate originally raised in an article by Peter Doshi and colleagues in Plos Medicine, and open-access journal. http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001202.
The European voice suggests that the non-disclosure of comprehensive trial data undermines the philanthropic view that patients involved in clinical trials assume that they are contributing to medical knowledge. They welcome discussion of the issue that full clinical trial reports on licensed drugs should be made publicly available to enable independent re-analysis of these products’ risks and benefits.
However, there are some negative factors to consider: Patient confidentiality is obviously a key issue, with the possibility that those in trials for very rare diseases potentially being at risk of being identified from anonymised datasets. In addition, there is a risk unrestricted availability of some datasets may in some cases facilitate publication of papers containing misleading results and, in the worst case, give rise to unfounded health scares and negative public health consequences such as patients refusing vaccinations or discontinuing drug treatment.
Despite this, the feeling is that clinical trial data should not be regarded as commercially confidential information, and regulators say that there should be maximum transparency whilst respect is given to the need to guarantee data privacy and to avert the potential for misuse. The debate continues….