Transparency of data is paramount to scientific communities worldwide and a sine qua non for the unbiased technological advancement. This, naturally, also refers to scientific research in medicine. As we read on through the European Medicines Agency’s (EMA) mission and responsibilities, transparency comes as its integral and prominent feature. As part of its operations, the Agency is taking noticeable actions in order to address growing demand for the accessibility of data and results from clinical trials submitted as part of the marketing authorisation process.
A staggering response that followed the release of Policy 70 for public consultation in June 2013 reflects the interest of various stakeholders such as pharmaceutical industry, academia, patients and healthcare professionals, health-technology-assessment bodies, national medicines regulators, the members of the European Parliament, the European Ombudsman and European Commission in the availability of clinical data for further scientific scrutiny and reuse. Since the publication of the EMA previous policy on access to documents in November 2010 until April 2013 over 1.9 million pages containing clinical trial data were released in response to requests by patient organisation, pharmaceutical companies, healthcare professionals, academia, not-for-profit organisations, regulatory bodies and other individuals or institutions.
The Agency has long ago acknowledged potential gains for the public domain arising from open review and independent re-analyses of data after the medicinal product has been authorised. Availability of clinical trial data should lead to more efficient development of new therapies, bolster better-informed use of medicines, and facilitate verification of the regulatory authority’s decisions by third parties. However, concern remains regarding patient confidentiality, possible conflict of interests and independent analyses’ vulnerability to distortion as well as the risk of moving the research and drug development activities outside of the EU to avoid data sharing. In order to minimise these risks measures are taken ensuring best possible protection of patient personal information and the prevention of unfair commercial use of data, particularly outside the EU.
It should be once again clearly stated that the EMA has publicly recognised the potential benefits for public health of re-analyses of data for marketed drugs by independent academics and researchers, and acknowledged that regulators do not have a monopoly on science.
The policy on publication of the clinical board was discussed at the Management Board meeting on June 12, 2014. According to the minutes published at the EMA webpage, the Management Board endorsed the general approach, and also the proposal to include a more user-friendly solution for academic and non-commercial research purposes.
The draft policy will be discussed again at the Management Board meeting in October 2014. If approved, the policy will serve as a complementary tool preceding the implementation of the new clinical trials regulation foreseen to come into force earliest in May 2016.
European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use). EMA, November 30, 2010.
Publication and access to clinical-trial data (draft for public consultation). EMA, June 24, 2013.
European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments. EMA, June 12, 2014.
Release of data from clinical trials. EMA.
Minutes of the 84th meeting of the EMA Management Board held in London, 12 June 2014.
Eichler H-G, Abadie E, Breckenridge A, Leufkens H, Rasi G (2012) Open Clinical Trial Data for All? A View from Regulators. PLoS Med 9(4): e1001202.