EPHA joins calls for enhanced clinical trial transparency and good governance in the European Medicines Agency

The COVID-19 pandemic has highlighted the importance of addressing shortages of critical medicines and coordinating clinical trials for the development of new medicines. It has also shown how a lack of transparency on clinical trials threatens to delay the development of critically needed therapies and vaccines. Enhanced transparency of clinical trial data can prevent duplication and allows for crucial insights into treatment effectiveness.

Transparency is not only a matter of acting effectively in the face of public health emergencies; it is also a crucial responsibility towards society. Past experiences show that public visibility of the trial reporting and data management performance can significantly, and at zero cost, increase the quality and quantity of trial data available to relevant stakeholders both during public health emergencies and beyond.

EPHA has joined the call led by the European Alliance for Responsible R&D and Affordable Medicines to urge EU Ministers to  ensure that the Regulation for a reinforced EMA role leads to enhanced clinical trial transparency and upholds good governance. We call on Member States and the EMA to make the most of the Clinical Trial Regulation and ensure that any Clinical Trials Information System (CTIS) monitoring data capturing stakeholders’ performance is made publicly available in full and on an ongoing basis through the public CTIS interface. This will facilitate public accountability and translate into greater compliance. We also call on the EU institutions to ensure that information on clinical trials is communicated in a timely, user-friendly, and comprehensive manner during public health crises.

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