Bracane Company was founded in 2002 for the unique purpose to dispel the myths about clinical research in minority communities and to increase minority participation in clinical research as study participants, professionals, and service providers.
Increasing Minority Participation in Clinical Research
Diversity doesn't start with the study participant but is the result. Diversity begins at the top of the pyramid. As we know, the top is the smallest. There are three areas of focus that can impact diversity in clinical research:
The industry must increase the participation of minority healthcare providers located in the area where minorities work and live to increase participation.
Increase the number of minorities that interact and work with minority healthcare providers (HCP).
Conduct business with minority companies in the clinical research space.
The industry must recognize that unconsciously, our biases are the limiting factors for the inclusion of minorities in clinical research. Some of the ways minorities are excluded from participation are popularity, location, convenience, and experience.
Exclusion by Popularity
We all like to do business, interact, and socialize with people that we know and like. The same premise follows in healthcare. Multiple factors impact access to healthcare and healthcare providers in the research industry, and after more than 20 years in the industry, the conversation is still the same. Minority HCPs in inner-city or rural locations are less likely to be visited or sought to conduct clinical studies. Contributing factors include their location, lack of experience conducting clinical trials, or they are not known to the CRO or pharmaceutical company conducting the clinical research.
Exclusion by Location
The continuing saga that clinical site selection results from their ability to rapidly enroll or long-standing performance history should not be the only indicator for site selection. Some pharma companies and CROs are making an effort to require sites to commit to enroll a percentage of diverse/ minority participants, but there are limits on how they recruit. As a study manager, I look at the feasibility reports. Generally, I can predict that the site will have limited success in reaching a diverse population by zip code alone despite the response provided.
Exclusion by Convenience
One example that I had an opportunity to experience was with a minority physician in a rural setting in East Texas. The HCP was new to clinical research but completed a training program and put in place the necessary tools and programs to ensure success. Participants were not an issue, as he had a sufficient number of potential participants who met the study's criteria. With much encouragement to the sponsor, the HCP was selected to patriciate and enrolled a significant number; however, the high enrollment required frequent visits to his site for monitoring and study oversight. Unfortunately, his site was not chosen again by the same sponsor for other studies, not for poor performance but because of the difficulty accessing his clinical site for the study team.
Exclusion by Perceived Risk
As an advocate for HCPs and potential study participants, clinical trial participation can reduce healthcare disparities by bringing emerging therapies and technologies to diverse communities. We need to continue to push for breaking the barriers for HCPs in community settings in inner cities and rural communities to be clinical investigators for clinical trials. Education and awareness are not the answer. The solution includes support after the training program and actual selection to participate in a clinical study. There is an expectation that the newbie investigator will have challenges and pose risks to clinical research. However, is that risk any greater than the site that is chosen repeatedly and performs poorly, does not complete the work in time, poses problems because the PI is not engaged, has high staff turnover?
Check out this segment on ACRPTV: https://youtu.be/bnPgGzq3X4I
I welcome the opportunity to discuss the observations listed.
Bracane Company is a minority, woman-owned Clinical Research Organization providing functional clinical research services, specializing in study rescue, inspection readiness, and vendor oversight solutions for small to mid-size biopharma, the insurance industry, and government agencies.
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