Clinical Trials represent an integral component of biomedical research. These research studies utilize human subjects to evaluate an experimental intervention. Clinical Trials can lead to the development of a new drug, the discovery of an optimal surgical or diagnostic technique, or the understanding of a beneficial behavioral intervention. Clinical Trials often evaluate the efficacy of a new approach and the potential side effects compared to the standard method.
No matter the specific goal of a Clinical Trial, all aim to improve human health with novel, safe, and effective approaches. Doctors and researchers perform Clinical Trials for all types of diseases, disorders, and medical procedures. Clinical Trials executed for cancer research seek to uncover new ways to prevent, diagnose, or treat cancer and improve the quality of life of cancer survivors.
Arguably the most critical piece of a Clinical Trial is the patients who volunteer to participate in the hopes that their contribution will advance research and ultimately benefit others. Because Clinical Trial participants volunteer, researchers cannot always control the patient population in each case. Researchers have begun to emphasize the importance of diversifying Clinical Trial cohorts to ensure they represent the expected patient population. In fact, we recently discussed the push for inclusion of more elderly patients in cancer Clinical Trials.
According to the 2021 Drug Trials Snapshot, the FDA approved 15 new cancer drugs. The proportion of White participants in the Clinical Trials related to these 15 drugs ranged from 35 to 95% (average ~77%). Asian, Hispanic, and Black participants made up about 13%, 6%, and 4% of these Clinical Trials, respectively. The 2020 US Census found that about 13% of the population was Black, 19% was Hispanic, and 7.2% Asian. Notably, health disparities exist in many chronic diseases, including cancer, resulting in higher diagnoses in minority populations. Thus, these statistics highlight the underrepresentation of these demographic groups in Clinical Trials for cancer research.
Last Spring, a group or experts convened to discuss how to improve diversity within Clinical Trials. Contemporary Clinical Trials recently published a review of the proceedings of this conference. The conference attendees included practicing clinical researchers and physicians, data analysts, patient advocates and representatives from government agencies (the National Institute Health and Food and Drug Administration), pharmaceutical and medical device companies, and community organizations.
The article states that “improving diversity in clinical trials is of the utmost importance, not only to enhance representation, but also to ensure the generalizability of, and trust in, results.” The authors acknowledge recent advances in promoting diversity and inclusion in Clinical Trial participants but admit that the US still falls short of reaching the optimal representation of the US population. The stakeholders suggested ways to increase recruitment and retention of diverse volunteers in Clinical Trials, including advertising among diverse populations, understanding the reputation of the Clinical Trial Center within the community, engaging with community partners, and building community engagement into the budget. These methods could better represent minority groups in Clinical Trials and directly result in more effective drug interventions and medical advances.
Sources: FDA 2021 Snapshot, Biomed Res Int, Contemp Clin Trials