Increasing Diverse Clinical Populations: Sex

By Sinead Callinan, Executive Director of Delivery EMEA

The lack of representation and diversity in medical research reveals a lack of access to trial participation for many segments of the greater human population. As a result, it can limit the validity and generalizability of conclusions drawn from study data. Attracting a diverse population of patients for a clinical trial is critical to develop effective, safe therapies and long-term population health. Drugs and therapeutics may impact different persons —— in vastly different ways depending on age, race, sex, and other factors. Therefore, trials need to draw on diverse groups of patients to ensure reliable and representative data is collected. This three part series will examine the varied challenges and solutions to increasing diverse clinical populations. In Part I, we’ll look at how research can better address often overlooked gender based differences as an underappreciated variable in the evidence generated in the clinical development lifecycle and why extrapolation of results from one gender to another is objectionable.