Last Updated on April 30, 2024
Clinical trials are crucial to medical growth because they help doctors develop new treatments that save lives. However, the need for more diversity in clinical trial participants compromises study reliability and efficacy. In this Blog, we emphasize the importance of diversity in clinical trials and how it seeks to foster inclusiveness in drug development.
The Importance of Diversity and Inclusion in Clinical Trials
A lack of diversity in clinical trials can have serious public health consequences. The results may not represent the general population if they only contain individuals from a limited demographic group. As a result, specific populations may receive medications and treatments that are less beneficial or even dangerous.
Consequently, variations in age, ethnicity, gender, race, and sex can impact the safety and effectiveness of vaccinations and medications. A clinical study must include a diverse group of patients to apply the results and findings to all patients. Additionally, because some diseases affect racial and ethnic groups more than others, regulators have begun to make it clear what they expect from clinical trials in terms of variety.
Why Does “Who” Participate in Trials Matter?
We rely on existing studies for information about a drug’s potential safety, efficacy, and chances for adverse effects. However, people with various origins may experience those consequences in different ways. Certain medications may have specific impacts on various age groups, genders, and demographic groups. If the research population is more diverse, trials that accurately reflect the intended patient group will be able to predict outcomes and findings for a more significant number of participants.
For instance, Black people’s reaction to therapy did not continue as long as White people’s in one study involving MS (Multiple sclerosis) patients. Those with red hair get a shorter duration of effects from local anesthesia. Because medicine dosages have traditionally been based on studies done on men, it is thought that women are more likely to experience some harmful side effects of drugs. Treating illnesses requires evaluating how various groups react to multiple medications.
Increasing diversity in clinical trials is necessary, as is acknowledged. In the US, the FDA(Food and Drug Administration) released guidelines in 2020 with a particular emphasis on enhancing diversity.
Statistics about Diversity in Clinical Trials
Since the late 1990s, there’s been a notable increase in countries contributing data for FDA drug approvals. However, despite this growth, a significant portion of the data—57%—still originates from study sites in the US.
However, there has yet to be much of a shift in the participants’ diversity. Twenty years later, 86% of the trial participants were white, down from 92% when they started.
And 75 percent in 2020.
75% of the people who took part in clinical trials for all the drugs approved by the FDA in 2020 were white, 11% Hispanic, 8% African American, and 6% Asian. Over half of the patients were in the United States, and just 30% of the participants were over 65.
Factors Affecting the Lack of Diversity in Clinical Trials
Clinical trials are extensive tests for new medicines and treatments before they’re available to everyone. But there’s a big problem: only some get to participate in these tests. Let’s explore why.
Historical Exclusion:
In the past, some groups, like minorities, weren’t included in these trials because of unfair treatment and discrimination. Consequently, we don’t have enough information about how treatments work for everyone.
Limited Access:
People who don’t have a lot of money or live far away from where the tests happen might be unable to join. Because they can’t afford to travel or because no clinical site is available nearby.
Different Cultures and Languages:
Some people might not take the tests because they need help understanding the information or feeling uncomfortable. Moreover, this may be because the information isn’t in their language or doesn’t consider their society.
Distrust:
Some communities don’t trust doctors or the healthcare system because of bad experiences in the past. They might worry that they won’t be treated well if they join the clinical trial.
Type of trials:
The tests mostly happen in big cities, so people who live far away or in small towns might be unable to join.
Age and Gender Gaps:
Older adults and women are sometimes excluded from the tests, so we need to learn more about how treatments affect them.
Lack of Incentives:
Some people can’t join the trial because they don’t get paid for trials or have to take time off work, which they can’t afford to do.
Here is the proper guide to clinical trial compensation: A Guide to Transparent Clinical Trial Compensation Guidelines
Biases in Healthcare:
Sometimes, doctors or researchers might only include certain groups if they have biases or must realize they’re doing it.
By understanding these reasons, we can start to fix the problem. We must ensure everyone has a fair chance to join these tests and benefit from new treatments.
Strategies for Improving Diversity in Clinical Trials
Choose close locations to the communities.
Convenience is sometimes a barrier to patient participation. Therefore, choosing study locations that are close to the communities you want to reach can have a significant impact on participant demographics.
Provide alternatives for hybrid site visit participation.
It’s essential to consider potential participation barriers that could adversely impact people of color while creating patient-centric clinical trials that appeal to a diverse patient group. Fascinatingly, Antidote discovered that hybrid participation options—home visits or electronic check-ins in addition to site visits—were particularly significant to non-white people in a survey of more than 4,000 patients. Thus, collaborating with websites that provide these hybrid participation choices might be a calculated approach to boost minority involvement in your research.
Support groups that can effectively engage with a variety of communities.
Partnering with organizations that specialize in reaching various groups can be very beneficial when recruiting for clinical research. For instance, Antidote has collaborated with the National Minority Health Association to benefit from their knowledge of connecting clinical trial possibilities with communities of color.
Increase participant and researcher trust.
Underrepresented populations may mistrust the medical system for a variety of reasons, all of which need to be addressed to bring about real change. Clinical Ambassador and iParticipate founding partner Allison Kalloo, MPH, states, “[The] underrepresentation that we encounter today is much more about current affairs and implicit bias, access to healthcare, and practice of medicine, and less about historical issues.” Comprehending the origins of historical and contemporary mistrust will enable all parties engaged in clinical research to initiate authentic partnerships in the future.
Employ advertising that appeals to a variety of demographics.
Digital marketing knowledge can be leveraged to target audiences more effectively during online outreach. Market your clinical research site to a clinical trial sponsor. Reaching specific patients with great precision is feasible through location-based ad targeting, imagery that mirrors the target population, and data from partners in a given therapeutic area.
Wrapping-Up
Ensuring diversity in clinical trials is not just a matter of fairness; it’s essential for the health and well-being of everyone. A lack of diversity in clinical studies can inaccurately represent the community, causing harm or missing treatment possibilities.
Understanding diversity and inclusion in clinical trials helps us solve the root causes of underrepresentation. Improving diversity strategies in clinical trials relies on reaching out to diverse communities and building trust with participants. Providing alternative participation options is also crucial.
At Minerva Research Solution, every trial program starts with a draft of a diversity plan in clinical trials that lists the number of minority participants participating in the study. Additionally, it provides clinical trial diversity support.
Ultimately, embracing diversity in clinical trials ensures that healthcare innovations benefit everyone, regardless of age, ethnicity, gender, or socioeconomic status. It’s not just about fairness but advancing healthcare equity and improving outcomes for all.
