Diversity and Recruitment of Minorities in Clinical Trials: An Unmet Need

Abstract

Patient centricity has led to the idea that drugs should answer medical needs not only defined by the medical bodies but relevant
for the patients themselves. This implies that the diversity of the patients should be represented in clinical trials. Disparities in
representation of diverse populations in clinical trials have been well-documented for several pathologies like arterial hypertension,
diabetes but also in oncology. Today, Caucasian patients included in clinical trials represent at least 75% of the clinical
trials population even in pathologies where minorities are largely more affected than Caucasians. Filling the gap in diversity is an
important matter to ensure ethics, good practices, regulatory compliance, patient safety and scientific validity. To achieve their
recruitment goals and being patient centric, sponsors and investigational sites need to pay attention of this problem and put in
place specific strategies. Mistrust of patients of minority groups toward clinical research is one of the main barriers along with
lack of access to clinical trials (low awareness, communication barriers, distance to investigational sites). Adapted communication,
community-based strategies are some of the useful strategies directed to the patients. Investigators may not encounter
diverse populations in their area or may not be aware of unconscious bias when identifying patients suitable for a clinical trial.
Looking for referrals and raising awareness of the risk of bias with training on culturally sounded approaches could help investigators
to recruit more diverse populations. Lack of awareness and costs may prevent sponsors to focus on diversity but ethics,
benefits of data acquisition and patient centricity should be enough motivators to modify this trend. Patients, investigators and
sponsors have their own barriers to tackle the lack of diversity in clinical trials. The cultural background of all stakeholders is
an important factor in those barriers. Only multidisciplinary approaches including human sciences would help to define patient
recruitment strategies that would mitigate the current lack of diversity.