Early-phase clinical trials in oncology for adults in France: A preliminary empirical bioethics study

Abstract

The last few years have seen the improvement of cancer management through the arrival of a continuous stream of innovative new molecules known as ‘targeted therapies’ and ‘new immunotherapies’.¹ One characteristic common to all these treatments is a specific link to a precise cellular and/or molecular profile. Some of these treatments are already improving therapeutic results for certain types and subtypes of cancer.² However, a non-negligible proportion of these molecules remain inaccessible to patients other than through clinical trials, particularly early-phase clinical trials.³ The aims of such clinical trials were initially limited to identifying toxicities associated with the molecules tested, but they now extend to the evaluation of efficacy and possible therapeutic benefits for participants. We performed a preliminary empirical bioethics work at national scale in France, with specific protocolization,⁴ based on a non-systematic literature review, to deal with the ‘macro-bio-ethical issues’.

HCS, PB, CH and JB are the principal investigators. They contributed to the conception of the paper, the drafting of sections and discussions about how the different sections should be refined and integrated. TP is an undergraduate trainee who helped collect and process the data.

Foch Hospital.

HCS, TP and CH have no conflicts of interest to declare for the submitted work. PB has received personal fees from Astellas (educational sessions) and Pfizer (travel expenses to ASCO 2023), all outside of the submitted work. JB has received personal fees from AstraZeneca, Bristol-Myers Squibb, MSD, Janssen Cilag, Daiichi and Sanofi Aventis (advisory board, educational symposium and honorarium), all outside of the submitted work.