Inclusion of Women in French Psychiatric Clinical Trials: A Qualitative Study of Researchers’ Experiences and Challenges

Introduction: Since the thalidomide crisis, women have been underrepresented in clinical studies, leading to inequalities in knowledge and clinical consequences. International recommendations promoting women’s inclusion and gender consideration by the World Health Organization (WHO) and the Lancet Group highlight the recent increase in awareness. There is growing evidence that gender is a central factor in neurophysiological and psychiatric disorders in all aspects. In France, these specificities have been mainly unaddressed. Methods: We performed seven semistructured interviews with French psychiatrist researchers. Qualitative analysis was performed, and themes and subthemes were generated deductively on the basis of bibliography inductively via grounded theory. Semiquantitative analysis was performed via Iramuteq software. Results: In clinical practice, taking care of pregnant women is considered an anxious situation, as the safety of treatment is considered uncertain. The participants were favorable toward women inclusion without limitations. Clinical research associates are more burdened when dealing with the inclusion of women than with that of men. Relation with research ethics committees (RECs) is described as challenging, leading to the implementation of umbrella protocols and expecting refusals to include pregnant, breastfeeding and nonusing contraceptive women. Discussion: Underrepresentation of women in clinical trials in psychiatry has led to a gap in knowledge that cannot be filled by retrospective studies. Switching the paradigm from protection from research to protection through participation, as proposed by the WHO, could address this gap. We argue that biomedical research should move beyond the rigid application of the precautionary principle and adopt a precaution ethics approach, which acknowledges that lack of evidence can itself generate ethical risk. The fluctuation of anosognosia, which is specific to psychiatric diseases, may expose pregnant women to not seek help when they are experiencing a resurgence of symptoms. Criticisms made on French REC concur with international literature. Improving education in research ethics and facilitating communication between RECs and researchers may enhance the representation of women in psychiatric clinical trials.