Clinical trials include people who are the subjects of a research study that assesses the efficacy of medication, vaccines, or devices. Recently, one of the subjects that has been under scrutiny when it comes to clinical trials is ensuring diversity and inclusivity when research is being executed. The chief goal of including volunteers from different backgrounds is to establish health equity. Because medical products will be used by people of various ages and cultures, they should be represented in clinical trials. Most of the time, however, this is not the case. Underserved groups and minorities are usually overlooked.
Another reason for ensuring diversity and inclusivity is that individuals from different cultural and racial backgrounds may react differently to the same medical product. For these reasons, clinical trials are being diversified, and obstacles towards the reduction of disparities in research are one of the core subjects for researchers. A report published by the US FDA in 2020 suggested that in the approval of 53 novel drugs, nearly 75% of the participants in the research were white. The overrepresentation of white people and the underrepresentation of minorities can pose threats to the latter population. A balanced clinical trial can enable the production of life-saving therapies for minorities. What is being done to reduce this disparity?
The FDA Issues Draft Guidance
When considering clinical trial designs for investigational drugs, the FDA advises sponsors to incorporate a strategy to boost diversity. In June 2022, the agency urged the sponsors to come up with a “Race and Diversity Plan” while a new investigational drug application submitted. This plan will be a crucial part of a medical product’s development programme by the FDA.
The American Society of Clinical Oncology and the Association of Community Cancer Centers
The American Society of Clinical Oncology and the Association of Community Cancer Centers has issued a notice that will be used to increase the participation rate of people from diverse ethnicity and races in cancer studies. These groups have been historically underrepresented and are requesting the scientific community to show a strong commitment to enhancing inclusion, diversity, and equity in clinical cancer trials.
Other private sectors are also putting forth efforts to promote inclusivity and racial diversity.
Walgreens intends to launch a clinical trial business focused on increasing ethnic and racial diversity in the research of drugs. The firm has claimed to use its digital platforms and physical assets to ensure diversity.
Johnson & Johnson
Johnson & Johnson and Stand Up To Cancer have just announced a $5 million partnership that will increase diversity in early-phase clinical trials. Four research teams around the United States will get funding as a result of the agreement as they try to lower obstacles to patient enrollment, particularly for those living in medically underserved areas.
Pfizer has partnered with Headlands Research, a privately owned trial site, and aims to increase diversity and promote health equity by exploring new research sites where the population is more diverse and richer. To increase clinical trial participation, Pfizer’s ad campaign is focused on the black community.