According to a recent study by the investigative staff at Tufts University in Boston, Massachusetts, there is a direct correlation between the ethnicity or race of the site personnel and the participants in a clinical trial. An article featured in the Globe Newswire presents these findings which have been causing concern throughout the world.
And herein lies the challenge.
Tufts’ online analysis surveyed 3,462 investigators, site administrators, and study coordinators. Over half of the survey participants were based in community centers, academic medical centers, and major healthcare systems. Approximately forty-three percent were in private practice, site networks, and investigative sites.
Professor Ken Getz at Tufts University directed the study. Professor Getz commented that the study identifies areas ready for improvement by appropriate investigative site management and selection.
Tufts Impact Report outlines the study findings:
- Less than half of private-sector research centers and only one-third of academic center or community hospital personnel represent minorities
- In Europe, only ten percent of site investigators represent minorities.
- Sites with a diverse investigative staff are more inclined to develop programs to encourage diversity
- The most active areas found in clinical trial drug development tend to be staffed with highly diverse personnel.
Contributions by ICG-Next and its Multicultural Team
ICF-Next, a division of the International Coaching Federation, has a strong culture. The company employs multicultural healthcare experts with the goal of increasing awareness and building trust within communities.
The leadership points out that patients who truly represent diversity should be selected for these very important clinical trials. Studies show that there are millions of people deserving higher quality healthcare and inclusion in clinical trials.
Too often a drug being developed for a specific ethnic group is not being tested on that group. Despite sincere efforts and attempts being made for decades, there are still very few clinical trials that involve patients who are most likely to benefit from some of these new drugs.
Hispanic/Latino, African, Asian, American Indians, and people from communities with low literacy have experienced inequities as they are being denied advancements in healthcare.
The CDC Declares Its Commitment
In April of 2021, the CDC declared that racism, as well as inequity in the U.S., is now considered a health threat to the public. The CDC’s declaration states that it will confront policies that cause ethnic and racial health inequities. In some areas, medical treatment has been routinely denied to the aforementioned populations. They have had higher rates of heart disease, cancer, diabetes, and death.
Nevertheless, clinicians insist that conducting appropriately diverse clinical trials would create better results.
A Fresh Start
Communities with a disproportionately high population of people of color have finally been recognized in the rush to develop treatments and vaccines for COVID-19. Trial sponsors, clinicians, and researchers are now focusing their efforts on diversity in new clinical trials. These changes represent a refreshingly new start.
For decades the FDA has stressed the need to recruit people from groups that will most likely use the product. Yet there are so many clinical trials that are critically lacking in diverse representation. In answer to the constant call for change, the FDA has issued guidelines suggesting changes in enrollment practices and eligibility criteria.
PhRMA’s Announcement
Pharmaceutical researchers and manufacturers joined the effort to address racism in U.S. clinical trials. PhRMA has asked its members to help improve diversity by observing the new commitments and principles issued by the Association. The members should consider diversity when planning clinical trials.
Looking Forward
Although the FDA and PhRMA have set new and substantially high goals, it is evident that they must be achieved. The FDA’s guidelines and PhRMA’s principles represent a substantial change for many companies. This includes government entities that sponsor the trials.
The first step is to acknowledge that there has been an undercurrent of racism in recruiting for clinical trials. Secondly, implementing multilingual and multicultural recruiting, signals a true commitment to change.
