Europeans Medicines Agency (EMA) has initiated a public consultation to evaluate the transparency rules for publishing clinical trial data submitted via the Clinical Trials Information System (CTIS) across the European Union.
It has asked stakeholders to send their views through an online form by 28 June 2023.
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The consultation aims to stimulate discussions on finding the best possible ways to balance clinical trial transparency with requirements for privacy.
It also aims to simplify the methods of using CTIS to enhance user experience, as well as minimise the risk of data manipulations.
In a statement, EMA said: “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).
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“The simplification of the rules is meant to reduce the administrative burden for public authorities and sponsors of CTIS, but they will not entail decreased protection of personal data and commercially confidential information.
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By GlobalData“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.”
EMA also stated that interim guidance on personal data protection and commercially confidential details using the existing CTIS transparency rules has been amended after public consultation.
The amended rule is expected to help clinical trial sponsors and authorities to meet the CTR obligations.
Finalisation of the interim guidance on the basis of the existing transparency rules is anticipated to be completed in the third quarter of this year.
The CTR streamlines the procedure for applying for authorisation and supervision of clinical trials, irrespective of the locations of the trial sponsors and their national competent authority or national ethics committee.
