The U.S. Food and Drug Administration (FDA) released a consumer update focusing on diversity in FDA clinical trials.
The number of individuals who sign up for clinical trials does not accurately represent the diverse makeup of the nation. Because the FDA bases its approval on clinical trial outcomes, diverse participation is important for determining drug safety and effectiveness.
About FDA Clinical Trials
Clinical trials are scientific studies required for FDA approval. Though participation is voluntary, human participants are needed to determine the safety and effectiveness of new drugs, vaccines, devices and more. Trials are also used to measure additional uses for existing drugs.
A drug that may be safe for one population may cause serious side effects for others. According to the FDA, broad participation in clinical trials is the best method of developing a representative example of potential side effects that may impact the spectrum of users.
“Certain populations can be more at risk for certain diseases—such as diabetes and heart disease—than others. So it is important for patients in those populations who are more likely to be treated for a condition to be included in a trial,” the FDA wrote.
Including individuals of various ages, races, ethnic groups and genders is key to determine the risk/benefit profile. Developing a risk/benefit profile will help with prescribing practices for various populations.
Risks and Benefits
As noted by the FDA, there are various risks and benefits to trial participation. Because drugs involved in studies are previously untested, the substance may be dangerous. Risks or deterrents related to clinical trials include:
- Patients may be distrustful of medical research
- Patients may receive a drug or a placebo
- Risks may be unknown until after the trial
- Patients may not have time or resources to participate
History illustrates that clinical trials have resulted in injury or death of some participants. In 1932, the Public Health Service began a study called the "Tuskegee Study of Untreated Syphilis in the Negro Male." The study, which included 600 black men, did not involve informed consent for treatment. While the study lasted for 40 years, many men had been misled and improperly treated.
The Tuskegee study set a new precedent for clinical trial conduct to safeguard patient rights. Institutional review boards (IRBs) are used to maintain the study’s ethics by reviewing research prior to the study start date and during the research period.
FDA clinical trials representing the diverse and widespread U.S. population are the only way to determine the safety of a drug. While the FDA offers various resources on their website, the National Institutes of Health (NIH) also digitally tracks current trials at clinicaltrials.gov.
Due to demand, the FDA has announced they are working with “federal partners, medical product manufacturers, medical professionals, and health advocates” to improve trials.
The agency illustrated that while many medications treat illnesses commonly affecting older populations, elderly individuals aged 75 or older rarely participate in studies.
Before using a medication, each individual should research reviews of FDA clinical trials to learn about diverse participation and controversial outcomes.