The European Medicines Agency has announced a three-month public consultation on a draft policy on the publication and access to clinical-trial data. Comments should be made using the submission form and sent no later than 30 September 2013 to firstname.lastname@example.org.
The Agency has committed to the proactive publication of data from clinical trials submitted in support of a marketing-authorisation application, once the decision-making process has ended.
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’, including, for example, the details of theinvestigational medicinal product itself, some in vitro studies or bioanalytical data characterising the product.
- Category 2: ‘open access’, such as 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’, covering 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. Data will need to be adequately de-identified according to a recommended minimum standard. Further, 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.
The Agency expects the policy to come into force on 1 January 2014. However, its implementation will be impacted by the outcome of two other closely related events:
- A number of court cases are currently ongoing that challenge the Agency’s 2010 access-to-documents policy. These cases will bring the opportunity for legal clarification of the concept of commercially confidential information.
- The ongoing legislative process to replace the current European directive on clinical trials.