Ethics review of decentralized clinical trials (DCTs): Results of a mock ethics review.

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Abstract

Decentralized clinical trials (DCTs) can be a valuable addition to the clinical trial landscape. However, the practice of DCTs is dependent on a regulatory system designed for conventional (site-based) trials. This study provides insight into the ethics review of DCTs. A 'mock ethics review' was performed in which members of European ethics committees (ECs) and national competent authorities (NCAs) discussed and reviewed a DCT protocol. Respondents expressed hesitancy toward DCTs and focused on potential risks and burdens. We advise to address these aspects explicitly when submitting a DCT protocol. We propose that both the benefits and risks of DCTs should be carefully monitored to advance the review and practice of this innovative approach to ethically optimize drug development.
Original languageEnglish
Article number103326
Pages (from-to)1-6
JournalDrug Discovery Today
Volume27
Issue number10
DOIs
Publication statusPublished - Oct 2022

Keywords

  • DCT
  • Decentralized clinical trials
  • Ethics committee
  • Ethics review
  • Research ethics

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