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Proposed multi-stakeholder platform to improve clinical trials in the European Union

 Advancing Healthcare Policy  Prescrire has responded to the consultation on the proposed key priorities for the platform, but chose not to apply for membership, in order to safeguard its independence.
Full article available for download (free)

In January 2022, the European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) launched the "Accelerating Clinical Trials in the European Union" (ACT EU) initiative.

One of the main objectives of this initiative is to establish a platform bringing together all relevant stakeholders, with a view to developing a better understanding of the perspectives of all parties involved in one way or another with clinical trials.

In March 2023, Prescrire responded to the public consultation seeking views on the creation of this platform (1). Among the dozen or so envisaged areas of focus, Prescrire felt that the multi-stakeholder group should initially concentrate on:

  • implementing the Clinical Trials Regulation;
  • analysing clinical trial data to support the development of healthcare policy and evidence-based decision-making;
  • a training programme for clinical trial investigators, to include modules on drug development and the regulatory framework.

Prescrire also advocated developing methodological guidance in order to support:

  • clinical research providing reliable, robust data and results regarding the efficacy and adverse effects of drugs and their utility for patients;
  • identification of research bias.

Drawing on the lessons learned from covid-19, Prescrire observed that during the pandemic, international regulators, including the EMA, had stressed the importance of large randomised comparative clinical trials as best able to provide the robust, reliable evidence needed for regulatory decision-making.

Prescrire also emphasised the importance of the transparency necessary for mutual trust, and the need for details on the positions and perspectives of the different stakeholders involved in the platform to be made publicly available.

In order to safeguard its independence and avoid any conflicts of interest, Prescrire chose not to apply to join the platform.

1- "Public consultation on ACT EU multi-stakeholder platform (ACT EU MSP) participation and priorities for discussion" Réponse de Prescrire, 23 March 2023: 4 pages.

©Prescrire 1 December 2023

Source: "Proposed multi-stakeholder platform to improve clinical trials in the European Union" Prescrire Int 2023; 32 (254): 306-307. Free.

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