Diversifying Clinical Trials for Regulatory Success – One Size Does Not Fit All
Racial and ethnic minority groups have been underrepresented in clinical research for decades, leading to an inadequate picture of safety and efficacy of the diverse end-user groups of marketed drugs. Perhaps this is owing to the assumption that trial results are universally generalisable, which may not always be the case – and regulators are taking notice (for instance, the FDA recently rejected Eli Lilly and Innovent’s PD-1 inhibitor, citing lacking diversity as one of the reasons for the decision). Consequently, Pharma must ensure that the demographics of study participants is reflective of the real-world population and include patients from all races, ages, and ethnicities to confirm potential demographic-dependent treatment responses & side effects. The continued underrepresentation of ethnic minority groups within trials contributes to health inequities and differential access to health care within these communities. These disparities further contribute to detrimental quality of life, life expectancy, morbidity, and mortality. To overcome this challenge, it is imperative that greater diversity within clinical trials become the new normal for clinical trials.
Regulators such as the FDA are becoming increasingly concerned about clinical trial diversity. The agency recently published a draft guidance asking companies to submit a Race and Ethnicity Diversity Plan during the early stages of clinical development, detailing how the manufacturer aims to enrol participants with varied racial and ethnic backgrounds. The agency urges these companies to implement measures that would reduce barriers to participation in trials including health illiteracy, cultural stigmas, and lacking understanding of the clinical research process. Following the COVID-19 outbreak, the US government also introduced new legislation, called the Diverse Trials Act, to address these issues. The effects were immediate, as Moderna announced that they would slow the clinical trial enrolment to ensure accurate minority representation for their COVID-19 vaccine trial.
With the introduction of new legislation such as the Diverse Trials Act, and the FDA’s drafted guidance to improve racial and ethnic representation in US clinical trials, it is becoming exceedingly important for the industry to drive clinical trial diversity. A commitment to a combination of reforms will not only build patients’ trust in the industry but also facilitate the development of improved treatments particularly in disproportionately impacted diverse communities.