The Importance Of Diversity in Clinical Trials

The people participating in clinical trials should represent the people who will use the treatment in real life. That allows researchers to identify differences in safety and efficacy across groups during the trial process.

Diverse groups of people who can participate in clinical trials
Ensuring a wide range of participants in clinical trials improves health outcomes for all demographics

Since the early 2000s, researchers and regulators have recognized that clinical trial participation lacks the level of diversity seen in the general population. In 2020, 75% of the 32,000 participants in 53 clinical trials for novel drugs were white. That’s a contrast to the U.S. population as a whole, where non-white racial and ethnic groups comprise nearly 40% of the population.

When diverse groups of people participate in clinical trials, they help scientists establish better standards of care, minimize outcome disparities between people of different ages, races, or genders, and create a more equitable medical system.

5 Reasons Why Clinical Trial Diversity Is Key

There is an important scientific reason for diversity in clinical trials: the people participating in clinical trials should represent the people who will use the treatment in real life. That allows researchers to identify differences in safety and efficacy across groups during the trial process.

In addition, researchers need to adequately document demographic information such as racial and ethnic background, age, and gender. In the past, failure to collect that information was a common practice. One review of 379 clinical trials funded by the U.S. National Institute of Mental Health between 1994 and 2000 showed that nearly half of the studies didn’t include complete demographic information about participants.

When scientists partner with diverse groups of trial participants, they can gain a more comprehensive understanding of how new treatments will work in the real world.

1. Account for Variation in Disease Manifestation

Every doctor understands that no two individuals will have the same experience with a disease or health condition. Myriad factors can affect the severity of illness, symptoms, complications, and recovery. In some cases, racial, ethnic, or genetic factors may play a role in how a disease impacts people.

Increasing diversity in clinical trials allows researchers to identify instances when innate characteristics like race or ethnicity affect how an illness affects certain individuals. In addition, diverse participant groups mean that researchers can identify differences in how different demographic groups respond to treatment.

By documenting differences in responses across populations during the trial period, researchers can help doctors make better-informed treatment recommendations in the future.

2. Improve the Quality of Clinical Study Data

One of the main goals of clinical trials is to increase biomedical knowledge. A recent report from the National Academies of Sciences, Engineering, and Medicine noted that increased diversity could improve the generalizability of research findings, produce new scientific and biological insights, and help researchers develop targeted therapies.

Larger, more diverse groups of participants offer researchers the opportunity to learn more about treatments and how they work for various groups of people. The overall body of knowledge is increased when scientists can see how people of different ages, races, genders, and ethnicities respond to new therapies.

3. Ensure the Effectiveness of the Treatment

Clinical trials are a critical way for scientists to learn about the differences in efficacies across patient groups. For example, research has shown that women are more likely to have adverse drug reactions than men are . The lack of representative participation in trials can lead to adverse outcomes in real-world applications of treatments. In the case of 5-fluorouracil, a commonly used chemotherapeutic drug, researchers noted a risk of adverse effects, including hematological toxicities. The risks are higher for African Americans. However, prior research had lacked sufficient participation by African American patients to identify the risk and what real-world health outcomes were affected.

In another example, researchers have noted that certain cardiovascular medications have different clinical results between white people of European ancestry and African Americans. Given the significant need for cardiovascular disease treatment among African Americans, this information is crucial to providing optimal healthcare.

4. Foster Health Equity

Equal access to health care and medical treatments is a goal for the medical and scientific community. Equity includes the assurance that doctors know how a treatment is likely to affect a patient before suggesting it. That assurance isn’t guaranteed when there isn’t data on how the treatment impacted people of different ages, races, ethnicities, and genders. Diverse groups of clinical trial participants and robust documentation of demographic data help scientists and doctors improve understanding of treatment results across groups. This, in turn, ensures that clinicians have the knowledge to provide the best treatment for each individual.

5. Reduce Risk of Adverse Effects

Studying the effects of new treatments on a diverse group of participants can reveal potential problems with the treatment. Researchers can identify issues that certain groups of people experience and document the physical effects of administering the therapy. This data can help researchers and regulators provide guidance that can prevent doctors from prescribing treatments to people who might experience adverse effects.

In addition, studies on diverse trial populations can increase trust in the safety and efficacy of the therapy and, potentially, a higher likelihood of using it. A report from 2022 showed that sharing the results of a drug trial with robust African American participation led African American patients to experience greater trust in the efficacy of the drug.

How To Increase Diversity in Clinical Trials

Increasing diversity in trial participation requires outreach into communities that haven’t always been aware of research opportunities. Experts suggest researchers can expand their participant base by recruiting participants from disease registries. Researchers can also partner with local health systems and community organizations to share information about research opportunities with people who might not be connected to academic medical centers.

Using online tools such as social media and targeted advertising can also help researchers reach more prospective participants. Web or app-based enrollment platforms can allow participants to apply for and participate in trials from home, reducing logistical barriers. Recent findings have also shown that artificial intelligence (AI) may play a role in increasing diversity in trials.

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With an easy-to-use cloud-based study management platform, you can make recruiting, onboarding, and retaining participants easier. The platform can also assist in gathering participant data, including complete demographic information, as well as health history and information on social determinants of health. Increase trial diversity, improve data collection, and increase the value of findings with Studypages. Learn more at StudyPages website or contact us for a free demo.