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

Abstract

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.

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

Conflict of interest statement

None of the authors reports interests related to the present work.

Dr. Laurie PAHUS reports consultancies for Astra Zeneca and Chiesi pharmaceuticals.

Dr. Carey Suehs has no conflict of interest to declare.

Dr. Laurence Halimi reports industry-sponsored grants and lecturer activities for GlaxoSmithKline, Actelion and Novartis.

Dr. Arnaud Bourdin reports industry-sponsored grants from AstraZeneca-MedImmune, Boehringer-Ingelheim, Cephalon/Teva, GlaxoSmithKline, Novartis, Sanofi-Regeneron; consultancies for AstraZeneca-MedImmune, Boehringer-Ingelheim, GlaxoSmithKline, Novartis, Regeneron- Sanofi, Med-in-Cell, Actelion, Merck, Roche, Chiesi; investigator/Co-investigator activities for trials promoted by AstraZeneca-MedImmune, Boehringer-Ingelheim, GlaxoSmithKline, Novartis, Regeneron- Sanofi, Chiesi, Actelion, Merck, Roche, Vertex, Galapagos; no personal financial support from a non-commercial source; no personal relationships with tobacco industry entities; no off-label disclosures.

Dr. Pascal Chanez, as an advisory board member, consultant or lecturer, has previously received honoraria or grants from Boehringer Ingeheim, Almirall, Centocor, GSK, MSD, Astra Zeneca, Novartis, Teva, Chiesi, Shering Plough and Aix Marseille University.

Dr. Dany Jaffuel reports advisory board membership, meetings and participation as an investigator in clinical trials sponsored by ASTRA ZENECA, AIR LIQUIDE, APARD, BASTIDE, BOEHRINGER INGELHEIM, BOSTON SCIENTIFIC, LOEWENSTEIN-MEDICAL, PHILIPS, RESMED, SEFAM, VIVISOL.

Dr. Julie Marciano has no conflict of interest to declare.

Dr. Anne-Sophie Gamez has no conflict of interest to declare.

Dr. Isabelle Vachier has no conflict of interest to declare.

Dr. Nicolas Molinari has no conflict of interest to declare.

For all authors reporting conflict of interest, none of the latter participated in or had any influence over the present analysis or manuscript.