Clinical trials are critical for the development of new treatment options for a wide range of conditions. However, inequities and systemic discrimination have created barriers to participation. While progress is being made, going the extra mile to ensure diversity in clinical trial participants is essential to ensure proper efficacy and overall safety.
Here’s a look at the history of inequities and systemic discrimination in medical research, the reasons for inequitable representation, and the importance of diversity in clinical trials.
Inequities and Systemic Discrimination in Medical Research and Clinical Trials
Clinical Research and Medical Discrimination Against Minorities
Despite multiple national-level initiatives aimed at increasing minority participation in clinical research, the battle is still largely uphill. Systemic discrimination within the medical landscape impacts more than service levels and care quality, often limiting access to healthcare at even fundamental levels.
The long-term poor treatment causes many minorities to be inherently distrustful of the clinical research community, causing some to shy away from participation. Additionally, abuses like the Tuskegee Syphilis Study increased this distrust.
Other barriers to participation can also play a role such as logistical challenges. Lack of transportation to clinical trial facilities or inability to attend appointments during allotted times further reduce the representation of minorities in clinical research. In addition, language barriers can play a factor to participating.
Cumulatively, this all results in underrepresentation of minorities in many clinical studies. As a result, critical experiences aren’t captured, preventing researchers from accounting for differences that can occur within various minority groups.
Exclusion of Women in Clinical Trials
The participation of women in clinical trials typically lags notably behind their male counterparts. One of the foundations for the disparity is regulations geared specifically to exclude women.
The 1977 Food and Drug Administration (FDA) policy that recommended the exclusion of women of childbearing age from Phase I and early-stage Phase II drug trials is a prime example. While the aim was to prevent drug-related incidents such as those that occurred with thalidomide – a drug that, when taken by pregnant women, caused severe birth defects in some cases – it ultimately limited the participation of women on a broader scale.
As a result, many clinical trials were conducted that didn’t involve women during the early phases. In turn, the studies couldn’t account for how drugs in development could affect women.
Additionally, women faced scheduling challenges that aren’t as common among men. Women often cited having to juggle professional, personal, and familial responsibilities as an obstacle. If the clinical trials weren’t designed with a degree of flexibility, participation among women often failed.
Even if exclusion isn’t part of the equation, scheduling issues lead to underrepresentation. When that occurs, both efficacy and safety have to be called into question.
Advances Towards Equality in Clinical Trials
In 1986, the National Institute of Health (NIH) issued a policy encouraging the inclusion of women (and minorities in clinical trials unless a reasonable justification was presented.
Additionally, in 1993, the passage of the NIH Revitalization Act by Congress also aimed to correct the issue, creating formal legislation aimed at ensuring diverse representation in clinical trials. The goal was to determine if there were any variables that impacted drug safety for women and minorities, increasing overall safety.
While progress was initially slow, diversity in clinical trials is occurring. Depending upon the disease being studied, we may see the majority of the patient population enrolled as female. And, there are certain indications being studies where it is an FDA requirement to enroll a percentage of study participants from different skin types. However, improvements and awareness is still needed.
The Importance of Diversity in Clinical Trials
Clinical trials are meant to measure the efficacy and safety of medications. When a study lacks diversity, doing so effectively isn’t plausible. Drugs can impact various ethnicities and genders differently. Since those differences can’t be accounted for without representation, treatments often reached the market that posed a marked risk to the underrepresented groups.
By improving diversity in clinical trials, the risk of unknown ill-effects in traditionally underrepresented groups diminishes. Additionally, it ensures efficacy across the broader patient population or, at a minimum, identifies if particular drugs are less-suited to specific groups.
Together, this leads to safer advances that are also more capable of helping the larger community. It also ensures that treatment options are developed for the wider population, giving more people viable pathways for improving their health.
Vial’s Commitment to Diversity in Clinical Trials
At Vial, diversity is a top priority. Along with hiring a diverse staff, Vial uses a range of recruitment methods designed to reach a diverse group of participants. Our approach is both efficient and effective, ensuring that clinical trials focus on a diverse representation.
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