Publication and access to clinical-trial data

European Medicines Agency, Publication and access to clinical-trial data, POLICY/0070, www.ema.europa.eu
Samenvatting: There is growing demand from external stakeholders for full transparency, not only about the European Medicines Agency's deliberations and actions, but also about the data and results from clinical trials (CTs) on which regulatory decisions are based. Following consultations with a broad range of external stakeholders and European bodies, the Agency has drafted this policy, which complements the existing policy on access to documents (related to medicinal products for human and veterinary use), which came into effect in December 2010. Consultation end date: 30/09/2013.

Uit het persbericht: In its draft policy, the Agency has defined three categories of clinical-trial data corresponding to different levels of access.

Category 1: ‘commercially confidential information’
This category covers clinical-trial data, information or documents that may contain commercially confidential information. These include, for example, the details of the investigational medicinal product itself, some in vitro studies or bioanalytical data characterising the product.

Category 2: ‘open access’
This category covers any clinical-trial data, information or documents that do not contain patients’ personal data. This information will be downloadable from the Agency’s website, at the time of publication of the European public assessment report (EPAR) for positive decisions, negative decisions or withdrawals.

Category 3: ‘controlled access’
This category covers clinical-trial data, information or documents containing patients’ personal data. These include individual patient data sets, individual patient line-listings, individual case report forms, and documentation explaining the structure and content of data sets. Protection of personal data is a fundamental right of European Union (EU) citizens, enshrined in EU legislation. For this category, two complementary levels of protection are foreseen to provide the best possible assurance against retroactive patient identification. Firstly, data will need to be adequately de-identified according to a recommended minimum standard. Secondly, access to these data will only be granted after the requester has fulfilled a number of requirements, including the signing of a data-sharing agreement.