CT CURE extends expedited review of multinational clinical trial applications on COVID-19 therapeutics

  • The project seeks to include therapies that bridge the gap between therapeutic and preventive treatments for COVID-19 symptoms
  • With this extended scope, CT Cure aims to engage new stakeholders interested in contributing to better prepare for future public health crises

CT CURE, the European Union (EU) joint action seeking ways to expedite assessment and decisions on multinational clinical trial applications related to COVID-19 therapeutics, has entered its final year. The project involves 15 EU Member States and now extends its scope to therapies that bridge the gap between therapeutic and preventive treatments in order to include as many clinical trials as possible and make the European Union a more attractive region for large, multi-country trials using master protocols.

This project, initiated in 2022, aims to provide a harmonised and accelerated assessment of multinational clinical trials with novel COVID-19 therapeutics using the Clinical Trials Information System (CTIS) under the Clinical Trial Regulation (Regulation (EU) No 536/2014) over a 36-month project period.

Novel COVID-19 therapeutics are defined as investigational medicinal products without marketing authorisation, investigational medicinal products with marketing authorisation for a different indication than this disease and COVID-19 therapeutics with a marketing authorisation used with a new posology or in novel populations, such as children.

Since its start, this project has witnessed substantial evolution in our understanding of the disease, notably after declaring the pandemic officially over in May 2023. Alongside this progress, therapies have become more complex as knowledge of the disease has expanded.

To leverage these advancements and to gain as much valuable experience as possible, CT CURE now seeks to attract therapies that bridge the gap between therapeutic and preventive treatment for COVID-19 symptoms, as well as all substantial modifications of these trials to enable further refinement and application of the project’s best practice guide.

Simultaneously, the project collects feedback on the utilization of its best practices guide on expedited assessment. This guide serves as the foundation for addressing future health emergencies as declared by the Emergency Task Force of the European Medicines Agency. The experience gained will extend beyond clinical trials related solely to COVID-19, including other expedited assessments such as the Mpox trials.

The overarching goal is to encourage the adoption of the best practice guide on expedited assessment, integrate the lessons learned and gain further experience. This accumulated expertise will be valuable to be used for training purposes of trial application assessors in EU/EEA. In this way, CT CURE reinforces its commitment to engaging with new stakeholders who share an interest in contributing to the preparedness for future public health crises of international concern.

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