Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials?

Laurie Pahus (1, 2, 3) , Carey Meredith Suehs (4) , Laurence Halimi (4) , Arnaud Bourdin (4, 5, 6) , Pascal Chanez (3, 1, 2) , Dany Jaffuel (4, 6, 7) , Julie Marciano (8) , Anne-Sophie Gamez (9, 4) , Isabelle Vachier (4) , Nicolas Molinari (4, 10)

1 Service de pédiatrie multidisciplinaire [Hôpital de la Timone Enfants - APHM]
2 C2VN - Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research
3 AMU - Aix Marseille Université
4 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
5 PhyMedExp - Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046]
6 APARD - Association pour l'Assistance et la Réhabilitation à Domicile
7 Polyclinique Saint Privat
8 Clinique Générale de Marignane, Marignane,
9 Département pneumologie et addictologie [Montpellier]
10 IMAG - Institut Montpelliérain Alexander Grothendieck

Background: Patient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research. The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in clinical research. Specifically, we sought to evaluate if distrust in pharmaceutical companies and associated psychosocial factors could represent a recruitment bias in clinical trials and thus threaten the applicability of their results. Methods: This prospective, multicenter survey consisted in the administration of a self-questionnaire to patients during a pulmonology consultation. The 1025 questionnaires distributed collected demographics, socio-professional and basic health literacy characteristics. Patients were asked to rank their level of trust for pharmaceutical companies and indicate their willingness to participate in different categories of research (pre or post marketing, sponsored by an academic institution or pharmaceutical company). Logistic regression was used to determine factors contributing to "trust" versus "distrust" group membership and willingness to participate in each category of research. Results: One thousand patients completed the survey, corresponding to a response rate of 97.5%. Data from 838 patients were analyzed in this study. 48.3% of respondents declared that they trusted pharmaceutical companies, while 35.5% declared distrust. Being female (p = 0.042), inactive in the employment market(p = 0.007), and not-knowing the name of one's disease(p = 0.010) are factors related to declared distrust. Distrust-group membership is associated with unwillingness to participate in certain categories of trials such as pre-marketing and industry-sponsored trials. Conclusion: Distrust in pharmaceutical companies is associated with a specific patient profile and with refusal to participate in certain subcategories of trials. This potential recruitment bias may explain the under-representation of certain categories of patients such as women in pre-marketing drug trials.

Mots clés: Clinical trials; External validity; Patients’ distrust; Recruitment bias; Under-representation of women

Domaines: Sciences du Vivant [q-bio]

Laurie Pahus, Carey Meredith Suehs, Laurence Halimi, Arnaud Bourdin, Pascal Chanez, et al.. Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials?. BMC Medical Ethics, 2020, 21 (1), pp.72. ⟨10.1186/s12910-020-00509-y⟩. ⟨hal-02915445⟩