Reed Smith Client Alerts

Clinical Trial Regulations On 21 January 2015, the European Medicines Agency (EMA) began a public consultation on the new European Clinical Trial Regulations (CTRs).

The new CTRs are designed to foster innovation by simplifying the clinical trial application process and increasing transparency and the availability of clinical trial information and results. A key change will be the introduction of a new, publicly accessible clinical trial portal and database, to be developed and maintained by the EMA.

However, the changes have raised concerns surrounding confidential information, in respect of both personal data and commercially sensitive information. The new CTRs provide two exceptions to the requirement to disclose and publish clinical trial information on the EMA database where personal data and commercially confidential information are concerned.

Commercial Confidentiality If these exceptions are adopted, sponsors of clinical trials could withhold information where disclosure may undermine their legitimate economic interests. Such circumstances may arise where the sponsor is planning future research in the same area and wants to maintain the confidentiality of its research plans. To address this concern, the EMA have suggested a graduated approach to the disclosure of information, based on the development phase of the clinical trial.

Patient Confidentiality The CTRs state that no personal data of trial subjects should be made public, nor should such data be included in the EMA database. Individual patient listings will therefore not be permitted to be included in the database. Additionally, even where an element of data relating to a single subject (for example, a single adverse reaction) is presented, it must not include trial subject identifiers. This concern, however, needs to be balanced against maintaining the usefulness of the data.

The public consultation will end on 18 February 2015. A further update will be published once the results of the public consultation have been published.

Client Alert 2015-039