University of Alabama Research Studies Whether Bias is Impacting Cancer Clinical Trials’ Participation

Mar 11, 2020 | Bias, Ethnicity and Race, Minority Participation in Clinical Trials, Patient Recruitment, Trust, Underrepresented Minorities

University of Alabama Research Studies Whether Bias is Impacting Cancer Clinical Trials’ Participation

The University of Alabama at Birmingham recently completed a study raising questions about racial bias in cancer research trials. Apparently, a subtle, or in some case not-so-subtle, bias against racial minorities—especially Blacks and Latinos—could, in some cases, adversely impact cancer research participation.

The Problem: Lack of Engagement, Trust, Need for Diversification

That clinical trials are frequently delayed—perhaps 80% plus of the time—because of patient recruitment and retention issues is well known to the clinical research industry. Out of the entire pool of patient population, 5% or less actually participate in clinical research—regardless of race or ethnicity. However, participation rates are even less in Black and Latino (Hispanic) communities. Well-known issues among “underrepresented” minority groups are understood by those that study the matter. In some cases, Black and Latinos face higher rates of certain diseases yet their participation in clinical trials that could extend or even save a life are known to be less than Whites.

A growing patient engagement movement centered on patient-centricity will evolve as the current way of doing clinical trials isn’t sustainable anymore. But this movement must not leave ethnic minorities behind—after all Black and Latinos make up nearly 100 million people—a vast population grossly underrepresented in clinical research. 

Research as a Care Option

This vast population also faces higher rates of poverty and economic and social hardship—including in many cases residual racial bias in the culture. Often this can manifest in less employment in high paying sectors not to mention less access to health care options.   Clinical research, if part of a holistic, people-centric care coordination-focused paradigm, represents an opportunity to connect those in the population in need of care with high quality health-related services. 

Personalized Therapies requires Diversity: FDA gets into the Act

With the evolution of drug development toward precision-based therapies, problematic disparities between clinical populations and the patients receiving new drugs represents challenges to overcome. While the research community drives form of scientific revolution in medicine—opening up the path to precision and even personalized medicine—the studies that lead to the approval of new drugs are often not demographically reflective of the patients of the real world.  With the rise of the precision medicine movement (e.g. targeted drugs, gene therapies) the lack of diversity in clinical trials can very well make it more of an obstacle for medical professionals to understand the complete picture of a drug’s safety-efficacy profile for example.

Even the FDA is calling for more diverse participation in clinical trials introducing “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry.” 

Trust is Earned

Some of TrialSite News’ principals have many years of experience working in and or near the patient recruitment efforts in clinical research. Frankly, the same problems tossed about in professional circles two decades ago are still discussed today. TrialSite News conducted a survey in Southeast Texas of African Americans for an interesting perspective on why there is mistrust, at least among this sample population. Albeit it wasn’t a scientific survey but nonetheless, for those open, it contributes to one’s thinking on the challenges of patient engagement in underrepresented minority groups. Trust is of paramount importance and it isn’t shared with government, healthcare systems or pharma easily.

All of this to convey the relevance and importance of this University of Alabama study. After all, shouldn’t researchers be interested in why their studies aren’t as representative as they should or need to be?

The Study

Published in CANCER, a peer-reviewed journal of the American Cancer Society, the University of Alabama (UAB) investigation involved a set of 91 interviews with research and health care professionals at five different academic centers concerning the recruitment of participants to cancer research studies. According to the researchers, bias against Blacks and Latinos was exhibited concerning that demographic suitability for participation in cancer research studies.

A novel study in that researchers haven’t focused much on actual clinical investigator bias (from a socio-demographic perspective), the research follows a more studied subject of clinical care. But the bias is in fact present among white clinical investigators when planning and conducting clinical trials. For example, the UAB study found that investigators expressed perceptions that African Americans were less knowledgeable about cancer research studies and moreover, for whatever reason, were considered less likely to participate in research out of altruism. Moreover, concerns of study completion seem to be associated with Blacks—e.g. they will drop out of the study at higher rates. Other bias emerges when dealing with English as second language populations—first and foremost applying to the large Latino population that may speak English as a second language.

Five Themes Emerge

The study produced five themes that should be noted, understood and dealt with by research institutions. They include:

·       Language barriers and other factors make community with minority potential clinical trial participants difficult

·       In some cases, researchers believe minority candidates are not ideal study candidates after they were screened for cancer clinical trials

·       Clinicians’ time constraints and negative perceptions of minority study participants as challenges

·       Respondents seek to address common perceptions to build trust

·       Some respondents find race irrelevant when screening potentially minority participants for clinical trials

Move away from Bias towards Inclusion

Stereotype-driven bias can drive multiple adverse outcomes. It is well known that more patients need to be involved with clinical trials. Bias against certain racial or ethnic groups doesn’t help contribute to the positive side of the ledger here. Moreover, in new cutting-edge cancer trials, where literally lives can be extended and even saved, Black and Latino patients may not be afforded the same opportunity if there was bias on the part of the research sponsor in how they went about designing and recruiting for the study in the first place. Hence, the potential for bias and stereotyping among clinical research professionals responsible for recruiting cancer clinical trials must be considered when formulating strategies to increase minority enrollment, reported the University of Alabama researchers.

Lead Research/Investigator

Soumya J. Niranjan, PhD, assistant professor, Health Services Administration, UAB

Call to Action: Clinical researchers: consider the FDA guidance for the agency’s perspective on the importance of this topic.