For many Black men and women, hearing the words “clinical trial” or “research” can lead to a sense of hesitancy and distrust based on the troubling history of medical research in our nation. However, it’s important to know that people who participate in clinical trials play an important role in the health and well-being of our country.
Historically, Blacks 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 trial participants are the same age, race, ethnicity, and gender, data from that clinical trial will fail to help researchers learn how different people may have different responses to the same medication.
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 avoiding unnecessary exclusions.
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. Sponsors are also committed to enrolling patients who better reflect the patients mostly likely to use the treatment being studied. In prostate cancer, all of these efforts will help ensure that sufficient data is collected and properly analyzed, with the goal of bringing more and more treatment options to patients.
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.
Today, more than 35 drugs are approved by the FDA for use in prostate cancer. Each of these drugs went through rigorous steps so researchers could understand safety, doseage, and efficacy, and each was studied in volunteers who chose to participate in clinical trials. Without these volunteers, clinical trials wouldn’t happen, and medical discoveries wouldn’t make it to patients who need them the most.
Several research studies and registries are now underway to help us learn more about prostate cancer in Black men:
Additional information on clinical trial participation can be found on ZERO’s Clinical Trials page, and information on all clinical trials currently enrolling prostate cancer patients can be found on clinicaltrials.gov.