Randomised clinical trials (RCTs) have long been considered the bedrock for evidence-based treatment (EBT). Thus they should be designed to be pragmatic and accumulate data representing the larger population for the disease profile. However, the research output is jeopardised severely by the limited enrollment of social, racial, and ethnic minority groups.
The FDA (US Food and Drug Administration) has reported that only 5% of patients partaking in clinical trials are Black, less than 2% are Asian, and as for Latinos, the percentage is as low as 1%.
This disparity is threatening, as it causes trials to show variance in effectiveness.
Releasing a draft guidance, the FDA has placed emphasis on enhancing diversity in industry-sponsored clinical trials (iCTs), reported Clinical Leader.
The agency urges investors and sponsors to devise and present a Race and Ethnicity Diversity Plan early in the trial process as per the framework delineated in the guideline.
Why Does Diversity in Clinical Trials Matter
Even though racial and ethnic populations in the United States have a disproportionate burden for specific ailments, they are most often underrepresented in biomedical studies, said the FDA.
With “underrepresented racial and ethnic populations,” the FDA indicates ethnic groups like “Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of colour.”
Considering the response and exposure of over 20% of drugs vary with racial differences, the FDA marks race and ethnic minority inclusion in iCT as a pressing need.
According to a study, white Americans are predicted to become a minority by 2045. The white demographic decline in the USA makes clinical trial diversification critical to confirm that newly developed drugs are safe and effective for whoever may use them across the country.
“The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” said FDA Commissioner Robert M. Califf, M.D. “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.”
Barriers to Improving Patient Participation Diversity in Clinical Trials
According to the FDA, the scepticism of the trial process stemming from several historical events deter ethnic minorities from participating in iCTs.
Other factors include limited access to healthcare for ethnic minorities, socioeconomic conditions, insufficient patient recruitment and retention efforts, time and monetary restraints, etc.
The result: gaps in clinical trial diversity that affects the trial success rate.
How to Fill the Diversity Gaps
What can help bridge the diversity gaps in iCT and accelerate effective products to market?
Decentralised Clinical Trial (DCT) Platforms
The COVID-19 outbreak has made sponsors realise the significance of DCTs in filling the diversity gaps in healthcare research and accelerating the long-overdue changes in trial design.
Let’s see how:
- DCTs and hybrid study models allow trial teams to expand their participant pools.
- DCT platforms such as ObvioHealth that include ePRO and eConsent enable patients to contribute to clinical trials from the comfort of their homes.
- By helping overcome barriers to participant recruitment, DCTs and hybrid models have encouraged a much higher enrollment rate.
The result: augmented trial outcomes that represent real-world patient populations.
Ethnically Diverse Workforce
According to research, the lack of workforce diversity in the USA has been highlighted as a leading factor impeding the inclusion of diverse populations and causing disparities in oncology trial results.
The good news? Studies found that 74% of Black and 81% of Latinx people are willing to volunteer for clinical trials if their physicians advise. With that said, engaging the workforce in clinical trials from underrepresented groups can help build trust with at-risk participants.
On top of that, the NHS recognised workforce diversity as the key factor to bring clinical trials closer to underserved folks.
Patient Expense Reimbursement
The FDA recognised patient expense reimbursement as an effective way to enhance clinical trial diversity. However, the lack of a consistent approach among CROs and regulators makes the process slow and ineffective.
The FDA sheds light on the significance of global efforts in increasing patient diversity. DCT can be a step change in helping sponsors improve the enrollment of participants from underrepresented racial and ethnic populations in clinical trials.