EMA Seeks Feedback on Clinical Trial Database
In 2014, the European Medicines Agency (EMA) made headlines when it announced it would require pharmaceutical companies to report the results of their clinical trials. Now, in a new notice, EMA is asking for help in determining how it should make that information available to the public, including how it should balance transparency with confidentiality.
Background
In April 2014, the European Parliament overwhelmingly passed its new Clinical Trial Regulation, with the aim of improving the environment for clinical trials in the EU.
Regulation (EU) No 536/2014 sets forth new transparency requirements for trials conducted in the EU and tasks EMA with the creation of a new clinical trials database and portal. The portal will be used for clinical trials applications, authorizations and supervision by governing bodies. The clinical trial database will be publicly available, except for where certain exceptions apply:
- protection of personal data
- protection of commercially confidential information
- protection of confidential communication between Member States in the preparation of their assessment
- protection of the supervision of clinical trials by Member States
These exceptions serve to protect the interests of the patients, companies conducting clinical trials and regulators’ ability to supervise clinical trials while providing relevant information to the public in a timely and transparent manner.
The regulation is set to go into effect some time after 28 May 2016.
Draft Proposal
In December 2014, EMA published the Functional Specifications for the EU Portal and EU Database to be Audited. The specifications outline the functional aspects of the database and portal required in the Clinical Trial Regulation.
Now EMA is asking stakeholders to comment on a number of functional aspects of the clinical trials database discussed in a draft proposal published 20 January 2015. Stakeholders are asked to give statements in support or in disagreement with specific portions of the proposal and to provide commentary on whether certain clauses in the proposal meet the requirements of Regulation (EU) No 536/2014.
Stakeholders have until 18 February 2015 to submit their comments on the proposal.
A Trend Toward Transparency
The EU is not the only area pushing to make clinical trial data more transparent. In November 2014, the Department of Health and Human Services announced its proposed requirements for clinical trials that “improve public access to information about clinical trials of FDA-regulated … products.”