EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union (EU). Stakeholders are invited to send their comments via an online form by midnight (CET) on 28 June 2023.
The review of the CTIS transparency rules seeks to stimulate the discussion on the best possible approaches to balance clinical trial transparency with confidentiality requirements while simplifying the modalities of use of CTIS to improve user experience and reduce the risk of data breaches. Any changes in the CTIS functionalities that might be required following the public consultation will maintain the high benchmark for transparency provided by the Clinical Trials Regulation (CTR). The simplification of the rules is meant to reduce administrative burden for public authorities and sponsors of CTIS, but they will not entail decreased protection of personal data and commercially confidential information. Following the public consultation, any revision to the transparency rules will be presented to EMA’s Management Board for approval and implementation before the end of 2023…
