By: Dr. Folakemi Odedina Professor of Hematology /Oncology / Mayo Clinic – What are Clinical Trials? According to the National Institutes of Health (NIH), Clinical Trials are “research studies in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”. Clinical Trials need volunteers to assess if medical therapies, interventions or devices are safe and effective. In other words, researchers find out if and how medical interventions work for medical conditions and groups of people through Clinical Trials. It is regarded as the gold standard for research and the primary reason why it is important for all groups of people to be represented in Clinical Trials.
How is the Black community doing relative to participation in Clinical Trials? The US Food and Drug Administration is responsible for protecting the health of the public by ensuring the safety, efficacy, and security of all human medical interventions, including drugs, biological products, and medical devices. In 2020, the FDA Center for Drug Evaluation and Research (CDER) approved 53 new drugs with 32,000 patients participating in the Clinical Trials of these drugs globally. As shown in the figure, only about 2,560 (8%) Blacks/African Americans (AAs) participated in Clinical Trials in 2020 all over the world. This is 1 in about 13 people. For cancer clinical trials, about 1 in 20 Clinical Trial participants was Black. A piece of good news is that in the US, the proportion of Blacks/AAs who participated in Clinical Trials between 2015 and 2019 is comparable to the population of Blacks/AAs in the US. We however still have a long way to go given that the Black community is significantly affected by health disparities, with a high number of diseases occurring in Black populations. We need to increase the representation of Blacks/AAs in Clinical Trials, especially for the leading causes of death in Black communities: heart disease, cancer and COVID-19.
What should you know about Clinical Trials? The US FDA provided the following important information about Clinical Trials:
- Clinical trials are research studies conducted with people—they are designed to answer specific research questions about medical products or therapies.
- Participation is always voluntary—you can leave a study whenever you want.
- Clinical trials often need healthy volunteers to help answer research questions.
- Your safety is a priority. Researchers must follow detailed protocols and the FDA’s safety requirements to make each trial as safe as possible.
- The study will be explained to you in an informed consent process before you agree to join.
- Participants in clinical trials should represent the patients that will use the medical products.
- Examples of questions to ask before joining any Clinical Trial are: (a) What is the purpose of the trial? (b) What kinds of tests and treatments are involved? (c) What are the possible side effects? (d) Will I be paid for my participation? (e) How will my personal information be protected? (f) Can I leave the trial at any time?
What is the next step if interested in Clinical Trials or for more information?
- Consider registering for the Mayo Clinic Florida Community Research Registry (CoRR) by taking one of the actions below:
- To find clinical trialsand clinical studies at Mayo Clinic to participate in,
- Please call 855-776-0015 (toll-free) for cancer Clinical Trials
- Please call 800-664-4542 (toll-free) for non-cancer Clinical Trials.
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By: Dr. Folakemi Odedina Professor of Hematology/Oncology
Assoc. Director, Center for Health Equity and Community Engagement Research (CHCR)
Site Director, Florida Center for Health Equity and Community Engagement Research (CHCR)
Director, CHCR Global Health Equity Initiatives