Historically, African Americans/Black people are underrepresented in clinical trials. According to a 2016 report by the FDA (Food & Drug Administration), African Americans make up only 7% of clinical trial participants, while white patients make up approximately 76% of clinical trial participants.
Diversity in clinical trial participation is critical to understanding the safety and efficacy of treatment options. When clinical trials lack racial/ethnic, age, and gender diversity, it is unclear how the treatments being evaluated work across these groups.
In 2020, the FDA issued final guidelines on Enhancing the Guidelines of Clinical Trial Populations. In an effort to improve clinical trial recruitment so participants more accurately reflect the population of patients most likely to use the treatment, this guidance expands and broadens eligibility criteria and discusses the importance of inclusion across groups (e.g. age, race/ethnicity, and gender).
Sponsors of clinical trials are encouraged to partner with advocacy organizations like ZERO, as well as solicit advice and insight from patients on how clinical trials are designed. Clinical Trial sponsors/funders must be committed to enrolling patients who reflect the patients mostly likely to use the treatment being evaluated.
Other standards related to clinical trials include rules on privacy, confidentiality, access to research results, informed consent, oversight committees, and the ability to stop participating whenever the patient chooses. Learn more about these terms and clinical trials here.
Prostate cancer patients volunteer for clinical trials for a variety of reasons. Some want access to cutting edge treatment options. Some want to give back to the research community. Some want to have additional care and attention from the clinical trial staff. Regardless of the “why”, ZERO wants to thank all clinical trial volunteers for their service to the prostate cancer community.
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world where you can search for prostate cancer clinical trials.