Abstract
BackgroundPatient 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.MethodsThis 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.ResultsOne 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.ConclusionDistrust 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.
Highlights
Patient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research
Public distrust in healthcare systems and directed towards physicians, regulatory authorities and the pharmaceutical industry in general has increased over the past decades [1, 2]
Rejecting the implementation of medical and scientific findings has major consequences for current public health, but may threaten future innovations and advances in medicine that principally rely on clinical research led by pharmaceutical companies, who have ever-growing needs for enrollment [15]
Summary
Patient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research. Pharmaceutical companies are suspected of putting profits above public interest, using marketing techniques to distort scientific evidence, and actively influencing both physicians and health policy makers [8,9,10] This weak level of trust translates into skepticism about using pharmaceutical products, leading to new patient behaviors ranging from poor adherence [11, 12] to strong rejection of health policies, such as vaccine campaigns [13, 14]. Rejecting the implementation of medical and scientific findings has major consequences for current public health, but may threaten future innovations and advances in medicine that principally rely on clinical research led by pharmaceutical companies, who have ever-growing needs for enrollment [15]. One of the main motivations for attending a highly-specialized clinic in France is the possibility of early access to new drugs or devices via participation in clinical research
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