Why is diversity in clinical trials so important?
Different people may have different reactions to the same treatment, based on their age, gender, weight, race, ethnicity, and other factors. Clinical trials rely on volunteers to take part, and it's vital that these people come from diverse backgrounds. When trial populations don't reflect the real world, it creates more roadblocks to finding better treatments and potential cures.
According to CenterWatch Weekly, September 19, 2022, “The U.S. population is becoming increasingly diverse,” said Mathilda Fienkeng, director of the Center for Drug Evaluation and Research’s Division of Medical Policy Development. “We need meaningful representation in clinical trials. It’s fundamental to FDA’s regulatory mission and overall public health.” The agency’s own data show the scope of the problem, Fienkeng said. According to FDA’s 2021 Drug Trial Snapshot, Blacks, Asians and Hispanics are woefully underrepresented in pivotal trials. Said the Snapshot, more than 38,000 people were included in the studies supporting the 50 drugs approved in 2021, but most of these pivotal trials contained fewer than 15 percent, Black patients, for example, and many contained no Black, Asian or Latin patients at all. Women and older people also comprised lower percentages. Minority populations are often excluded from clinical trials without strong clinical or scientific justification, Fienkeng said. Although not overtly intentional, these exclusions reflect the same barriers that separate affluent, largely white populations from the rest of the country’s population groups: community location, financial resources, family responsibilities, and trust of the medical and research communities.
DCOL Center for Clinical Research is committed to supporting the industry’s drive for more diversity in clinical trials. Our goal is to reach out to the diverse communities within our area to provide them an opportunity to participate in the clinical trials we have ongoing at our site. We routinely take part in activities such as trainings and webinars on diversity, and we also invite people from diverse populations from among the community to speak to our staff. Incentives are offered from time to time to the staff for ideas on how to better promote diversity when recruiting for our studies. The participants currently in our trials come from a widely varied population, but we strive to be even more intentional about recruiting and enrolling from diverse populations.
As a participant in a clinical trial, you are part of a process to evaluate investigational drugs and treatments that may help, or lead to a cure, for your condition. You will be one of the first people to reap the benefits of newly invented investigational drugs that are not yet available to the general public, and you will play an active role in furthering medical knowledge.
As a participant, you will receive free medical care from expert physicians. The trial is free for you, and you may even receive compensation for your time and travel. No health insurance is required, and all study-related medical exams, laboratory tests, and procedures are provided at no charge.
In addition to free medical care, participating in clinical trials helps millions of others with the targeted conditions. Lifesaving and life-improving drugs would not be on the market if not for clinical trials, so as a participant, you play a fundamental role in drug development.
Our team of doctors, research coordinators, and other medical staff have conducted numerous trials with hundreds of participants. We are dedicated to performing clinical research with the highest ethical and scientific standards.
You should feel comfortable asking the members of our research team questions about the clinical trial. You can also refer to Frequently Asked Questions to help guide you. It is also important for you to know as much as possible about the clinical trial. The Informed Consent Process should help you learn all the key facts about the trial.
You will be given specific instructions prior to each visit that applies to the protocol of your clinical trial. Generally speaking, you may be asked to do one or all of the following:
Yes - If you have a primary health care provider, then continue to follow your treatment regimen with your primary care physician. Your health care provider may even work with the research team to ensure that other medications or treatments will not conflict with the protocol. Most clinical trials provide short-term treatments related to an illness or condition and do not provide extended or complete primary health care. The clinical trial does not replace your personal health care provider but works in addition to it.
There are three phases that an investigational drug must go through successfully in order to be approved by the FDA. Following approval, there is a fourth phase in which drugs may enter for continued testing. At DCOL Center for Clinical Research, we participate in Phase II – Phase IV clinical trials.
You can learn more information about clinical trials, by visiting the websites listed below: