Uncovering the Exclusivity of Diversity in Clinical Trial Participation

Abstract

INTRODUCTION: Over the past several years, grant funding opportunities and clinical trial recruitment efforts have increasingly focused on enhancing the inclusion of diverse patient populations. Many define diversity as the inclusivity of people of different races, ethnicities, ages, genders, and socioeconomic backgrounds, while few studies have examined religious inclusivity in clinical trial participation. Our research sought to determine if religious exclusivity poses a barrier to clinical trial participation for Jehovah's Witnesses, whose core beliefs prohibit them from receiving certain blood products. The barriers for this group include provider misconceptions and unconscious bias about their ability to participate in research and investigators' concerns related to skewed data for patients unable to be transfused. METHOD: A clinical trial between November 2015 and April 2016 aimed to evaluate a blood substitute for adults with profound anemia unable to be transfused due to personal reasons or alloimmunization was analyzed to determine the percentage of eligible patients enrolled compared to the national average of 5%. The second aspect of our research was to determine how many patients with myeloid malignancies require transfusion support in general, as we believe this is a significant barrier that may be an unjustified inclusion criterion in many trials. This was conducted through an electronic search of our Electronic Medical Record (EMR) system to identify patients with primary myeloid malignancy diagnoses who were treated within our hematology oncology practice within the last seven years and required a blood transfusion. RESULTS: In the first analysis to determine the willingness of Jehovah's Witnesses to participate in a clinical research trial, 100% of the patients who were approached for participation (N=26) signed informed consent and were enrolled in the trial. Many of these patients were amenable to traveling long distances for this opportunity. Throughout these informed consent discussions, it was evident to the consenting physician that none of these patients were ever approached to participate in clinical trials. In the second portion of our research, from August 2017 through August 2022, 184 patients were identified as being treated for myeloid malignancies. Diagnoses included myelodysplastic disorders, chronic lymphocytic leukemia, chronic myelocytic leukemia, and acute myeloid leukemia. Only 37.5% of these patients required a blood transfusion of red cells or platelets, and 16% enrolled in therapeutic interventional clinical trials throughout that timeframe. CONCLUSION: Religion is an unacknowledged aspect of diversity by the medical community and poses an unnecessary barrier to clinical trial participation for certain religious groups. Our results identify a significant disparity in access to clinical trials for patients with myeloid malignancies where the inability to transfuse due to religious convictions is a common concern. Our pilot study's high clinical trial enrollment highlights that Jehovah's Witnesses are motivated to seek and receive the best medical care available when provided the opportunity. Inability to transfuse may not impact clinical trial results, especially as treatment options move away from cytotoxic agents to less myelosuppressive targeted therapies. Strategies to increase religious diversity should include better education of providers regarding religious restrictions and efforts made to accommodate patients by removing unnecessary eligibility criteria within trial designs. Potential religious barriers to clinical trial participation are not exclusive to Jehovah's Witnesses; practitioners of Hinduism, Judaism, and Islam should also be considered, especially given religious beliefs related to the use of animal products. Other barriers include strict clinical research scheduling, which may need to adapt to accommodate religious holidays and prayer times. We believe future clinical trial participation and efficacy will drastically increase by implementing the above strategies. Future research should examine providers' unconscious bias in approaching patients with known religious backgrounds about clinical trial opportunities. These actions are necessary to allow providers to successfully resolve the religious exclusivity of diversity initiatives in clinical trial participation.