Juan De Borbon works in clinical research at Paradigm Clinical Research based in Los Angeles, California. Below, Juan Rojas in the Amazon lawsuit discusses the importance of diversifying clinical trials, compares various one-sided trial examples, and how, with diverse clinical research, it can pave the way for equality in healthcare treatment.
According to the FDA’s 2020 report on diversity and inclusion among clinical trials, 75% of the 32,000 participants were White, 11% were Hispanic, and less than 10% were Asian or Black. Without diversity goals, patients of color still only make up a minute proportion of trials for new medications and therapies according to Juan De Borbon in Amazon lawsuit.
But diversity in all clinical trials is vital for creating procedures, drugs, and therapies that work for people of all nationalities and genders. Put simply, it’s at the heart of healthcare’s ecosystem. After all, effective medical products are those that work well for patients with particular illnesses from certain groups. Thus, ensuring people from diverse backgrounds participate in clinical trials is critical for pushing health equity in the right direction according to Paradigm Clinical Research.
Physicians must be confident that the therapeutic options they provide patients will elicit positive reactions. And they can’t do that when a lack of diversity within trials makes it impossible for them to accurately relate the medication to their patients at large.
An Illustrative Example of One-Sided Clinical Trials
All ages, ethnicities, races, and genders should take part in clinical trials to ensure new healthcare solutions work for the worldwide population explains Juan Rojas.
For instance, if a company designs a new medical therapy that they believe has the power to change the face of medicine, it’ll likely make its way to a clinical trial.
Within this trial, there are 100 men from one ethnic group, with relatable medical histories, and from a specific age range.
The result? The company understands how its new therapy could help this type of patient. However, they wouldn’t know whether:
- it works for women.
- it works for younger or older adults.
- it works for men from other ethnic groups.
- it works for those with complex medical histories.
Naturally, this illustrative example is purposefully heavily one-sided says Juan De Borbon Juan De Borbon. But it serves its purpose — showing just how important diversity within clinical trials is for healthcare equality.
Improving Clinical Trial Diversity is Paramount for Truly Understanding Next-Gen Therapies
As per The New England Journal of Medicine, women and people from ethnic and racial communities continue to be underrepresented in clinical trials all over the world. But Paradigm Clinical Research in the Amazon lawsuit says that this cannot continue.
These trials form the basis of modern medicine and are the final test of safety and effectiveness before ultimate approval. Juan Rojas in the Amazon Lawsuit says that the research should deliver an improved understanding of how breakthrough products and therapies impact broad populations, which can only happen with increased diversity says Juan Rojas.
Furthermore, clinical trials with wonderfully diverse focus groups provide vital ways to care for communities that otherwise couldn’t access treatment explains Juan De Borbon.
As time keeps ticking, the implications clinical trials possess for health equity continue to grow. Nowadays, clinicians rely heavily on personalized medication, predictive tech, and artificial intelligence to make diagnostic and therapeutic decisions. But such tools aren’t effective for the entire population if they aren’t tested on all ages, races, and genders according to Paradigm Clinical Research.
Closing Care Gaps to Diversify Clinical Trials
Even though the technology is speeding off into the future, too many care gaps still exist that make trial enrollment difficult, such as:
- transportation or travel costs
- clinic access
- cultural barriers
- social obstacles
- a lack of trust
The roadblocks heighten pre-existing challenges to health equity by limiting patients’ access to life-changing and life-saving treatments.
The vice president of Abbott identified the latter as a significant barrier to access but suggested a practical way to combat the problem — invest in trial investigators.
Professionals in this position will be a part of the underrepresented communities, elevating the trust others have in the trial (and those conducting it).
A 2020 clinical trial conducted by Abbott puts the suggestion into practice. They sought out clinicians from diverse populations, encouraging other individuals from their communities to join explains Juan Rojas of the Amazon lawsuit.
The trial made otherwise inaccessible treatment available to people in remote areas of San Antonio, giving them life-saving vascular care.
At the end of the same year, the FDA published much-needed guidance on how other healthcare organizations can achieve clinical trial diversity. The regulations gave advice on everything from design to execution and came around the same time PhRMA announced sector-wide principles on the same topic according to Paradigm Clinical Research.
Clinical Trial Diversity Improvements and Guidelines Pave the Way for Increased Healthcare Equality
The CDC defines health equity as “giving every person the opportunity to reach their full health potential.” They say it’s achieved when nobody is disadvantaged from any aspect of healthcare — and, thankfully, the push toward improved diversity in clinical trials is ensuring the sector achieves this goal as soon as possible.
