Historically, many clinical trial populations have lacked diversity and comprised predominantly white men. Because it is important that trial populations are representative of the actual patients to be treated with the investigational product, the U.S. Food and Drug Administration (FDA) has made a call for increased diversity in clinical trial participants. An article authored by FDA Commissioner Robert Califf in FDA Voice summarizes the current issues with trial recruitment and how the lack of participant diversity affects the evaluation of investigational drugs. Data gathered by the FDA show that “some groups, especially ethnic and racial groups, aren’t always represented in clinical trials” and that “these data are critical because certain groups of patients may respond differently to therapies.” His point is well supported by examples of underrepresentation of certain demographics in cardiovascular and schizophrenia trials and the resulting consequences.

In response to the need for greater trial population diversity, the FDA has planned or initiated several activities to encourage greater inclusion: the Diverse Women in Clinical Trials initiative, collaboration with the National Library of Medicine, and engagement with patient advocacy groups. Many of these activities are aligned with the goals of CTTI projects. For example, the CTTI Recruitment Project is developing communication planning approaches to engage all eligible participants and providers, including minorities and underrepresented populations. Furthermore, based on the results of the Informed Consent Project, CTTI recommends that the informed consent process be customized to meet the needs of each individual, and that those obtaining consent are trained to be responsive to potential research participants unique needs and concerns; these measures may help less health-literate participants feel comfortable participating in clinical trials. Finally, CTTI’s Patient Groups and Clinical Trials Project has provided recommendations on best practices for effective engagement with patient groups, which can facilitate involvement of patients from all walks of life.

CTTI is in agreement with the FDA’s call to action and is well positioned to provide support.