Decentralized Clinical Trials in the EU: Accelerating the Development of New Medicines

Introduction

The European Medicines Agency (EMA) is working to facilitate decentralized clinical trials (DCTs) in the EU. DCTs are a type of clinical trial that uses remote monitoring and other technologies to allow patients to participate in trials from their homes or other convenient locations. This approach has the potential to make clinical trials more accessible to a wider range of patients, and to reduce the cost and time of drug development.

The EMA’s Accelerating Clinical Trials in the EU (ACT EU) initiative is supporting the development of DCTs through a number of activities, including:

  • Issuing guidance on the use of DCT elements in clinical trials
  • Developing a methodology roadmap to identify and prioritise key advances in clinical trial methods
  • Establishing a multi-stakeholder platform to facilitate dialogue between all stakeholders in the clinical trials community
 

The ACT EU initiative is a major step forward in the development of DCTs in the EU. By making it easier to conduct DCTs, the initiative has the potential to accelerate the development of new medicines and improve access to clinical trials for patients.

 

Benefits of DCTs

Here are some of the benefits of DCTs:

  • They can make clinical trials more accessible to a wider range of patients, including those who live in rural areas or who have difficulty traveling to a clinical trial site.
  • They can reduce the cost and time of drug development.
  • They can improve the quality of data collected in clinical trials.
  • They can increase patient participation and retention in clinical trials.

The EMA’s ACT EU initiative is helping to make DCTs a reality in the EU. This is good news for patients, who will have more opportunities to participate in clinical trials, and for researchers, who will have access to a wider pool of patients and be able to conduct clinical trials more efficiently.

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