Ethnic minorities have been adversely impacted by the COVID-19 pandemic and associated public health crisis. TrialSite News has reported that in some regions African Americans die at up to three times the rates of others, for example. But our experience with the social determinants of health informs our knowledge on this topic. In the United States, not only one’s education and income levels but also ethnic and racial composition, may in fact impact their healthcare risks. This is nothing new: COVID-19 exemplified and magnified the problem—and continues to do so. This health inequity applies to other so called comorbidities. Health inequality, racial injustice, and clinical research have attracted some attention during the COVID-19 crisis. For example, a prominent National Cancer Institute (NCI) supported organization that conducts clinical trials in adult cancers called SWOG (formerly the Southwest Oncology Group), recently conducted a study revealing that SWOG and other NCTN trials do a better job enrolling African American cancer patients into pivotal drug trials as compared with industry trials. But the research results also reveal that SWOG and other publicly funded studies still don’t enroll enough black people to ensure they are fully represented in potentially life-saving cancer research. Consequently, the takeaway is that black people don’t have equal access to investigational and potentially life-saving, cancer drugs. An important implication: those drugs that are reviewed and approved by the U.S. Food and Drug Administration (FDA) are not tested on a representative population. Consequently, approved drugs lack a complete and accurate understanding of not only benefits but also side effects.
Introduction to SWOG
Founded in 1956 as the Southwest Cancer Chemotherapy Study Group, this cancer clinical trials network today comprises more than 4,000 cancer researchers at over 650 institutions around the United States and Canada. One of the largest of the National Cancer Institute (NCI) cooperative groups, member institutions include 24 of the NCI-designated cancer centers, many university medical centers, private institutions and Community Clinical Oncology Programs. Headquartered at the Oregon Health & Science University in Portland, they also run operations in San Antonio, TX, and a statistical center in Seattle, WA.
The SWOG Study
Dr. Joe Unger recently led a study identifying how well African Americans were represented in cancer trials—comparing publicly funded trials (such as NCI-funded SWOG studies) to private, industry-backed trials. The results: blacks don’t have the same access to advanced, investigational medicines as do others. The study found that publicly financed initiatives, such as NCI’s National Clinical Trial’s Network (NCTN), invest more in actual outreach to community sites, thus leading to a potentially more diverse representation in the actual study.
The researchers analyzed 358 clinical trials (industry = 85; SWOG = 273) including 93,825 participating patients ( industry = 46,313; SWOG = 47,512) for 15 cancer types. Industry-led trials included a total of 2.9% black patient representation with 9% for SWOG-based trials. African Americans make up about 12.1% of the U.S. population. The findings were consistent across different types of cancer.
TrialSite News principals have considerable experience in patient diversity and recruitment endeavors. In fact, one of the founders was involved with one of the largest patient recruitment firms in the U.S. nearly two decades ago. Unfortunately, the same research and discussions occurring now occurred back then. Over twenty years have gone by and countless diversity initiatives sponsored by both public sources and industry seek to spur involvement at the community level, not to mention countless calls to engage the underrepresented and underserved. Although well intended, these public sector and industry efforts have failed if the actual numbers are reflective of the targets of these programs. What the SWOG study reveals is that at least the publicly financed studies have made some progress. Industry, with its big marketing and public relations budgets, is a big failure on this one.
The TrialSite News African American Survey
Read the TrialSite News African American Survey in Southeast Texas for an eye opener. Why? Well, we found that first and foremost African Americans, at least the group surveyed, are in fact talking a lot about health care and are certainly interested in clinical research. However, most we spoke with were not very well informed about clinical trials, which surprised us given the amount of programs both the public sector and the private sector have funded over the last couple decades. Of more interest, 85% of those surveyed would be open to learning more about clinical research—especially if the topic was of relevance to a current adverse healthcare situation in the family.
We found that an overwhelming majority of those we surveyed had access to health coverage in the form of either public insurance (Medicaid, Medicare or VA) or private insurance via employers. On to the crux of the matter and perhaps the elephant in the room: over 80% of the survey participants expressed concerns involving trust and perception of inequality and financial pain associated with health care systems (e.g. whether in the hospitals or among the clinics, insurance companies, and the companies that produce drugs). Of course, a considerable portion of this perception stems from unfortunate historical precedent but what occurs today in the health setting that may prompt ongoing fears? One telling sign was economics: that the price of health services and products were so high many we surveyed even avoid “health system interaction” out of economic-inspired fear. The attitudes toward pharmaceutical companies is not great, at least in this survey.
But there are actions that can be done to strengthen trust and improve research participation. The research-as-a-care option movement has considerable potential if designed and executed in a patient-centric, culturally-sensitive and community-grounded way. Our experience with several care coordination initiatives, including community patient navigation, indicate that the concept of permanent community clinical navigators could have a profound impact on patient participation and, therefore, overall patient health. These navigators can be hired and recruited from the African American community (or for that matter Latino or other groups). The Medicaid Waiver can be employed as an instrument to finance the next wave of engagement and minority participation in clinical research. Perhaps the waiver can be tied to matching industry funds. Some may balk at such a proposition: what does Medicaid have to do with research? Everything. As research makes its way into the community, it becomes part of a treatment spectrum. One only need read how ex-Senator Harry Reid’s life was saved by an investigational pancreatic cancer treatment. Don’t we want to save black lives as well?