[Ethical principles for the design of a clinical trial in oncology]

Abstract

Clinical research in the area of cancer is of utmost importance in order to improve patient care, both in terms of overall survival and quality of life. The implementation of clinical trials on medicinal products, now falling under EU Regulation 536/2014, is conditioned on prior scientific authorisation from the French National Agency for the Safety of Medicines and Health Products and a favorable ethical opinion from a Research Ethics Committee (REC).

Objective: The objective of this work is to report on the main problematic issues identified during the evaluation of oncology dossiers by the REC in order to present the expected elements and thus optimise the evaluation procedures.

Methods: The National Conference of the Research Ethics Committees analysed the questions raised by the REC during their evaluation of clinical trials of oncology drugs submitted to the European information system in 2022.

Results: Out of a total of fourteen dossiers, nine were subject to ethical questions on the protocol and all dossiers required modifications to the information documents.

Discussion: The heterogeneous quality of the dossiers reminds the need to submit well-argued, methodologically robust protocols with supervised research procedures that are safe for the participants. The drafting of information documents needs to be thoroughly reconsidered in order to present clear, concise, loyal and respectful documents for patients' rights.

Keywords: Ethics; European regulation; Evaluation; Oncologie; Oncology; Recherche; Research; Règlement européen; Éthique; Évaluation.