Enhancing Diversity in Oncology Clinical Trials: Findings of a Case Study in Improving Black Patient Representation in a Multiple Myeloma Trial

Background: Black patients are underrepresented in multiple myeloma (MM) clinical trials. Despite the promise of Real-World Data (RWD), little research exists on RWD's usage to address this health disparity. In collaboration with a large pharmaceutical partner, we used RWD from commercial datasets (ConcertAI's Electronic Medical Record and claims datasets) aimed at identifying sites with a large Black patient population. We recommended including these sites in a recent clinical trial of Chimeric Antigen Receptor T cell (CAR-T) therapy for MM patients. Methods: We used the following criteria to identify promising sites: (1) high Black patient density, (2) access to a CAR-T accredited parent organization within 100 miles, (3) a hematologist/oncologist who treats MM patients, and (4) a history of treating MM patients with a Proteasome Inhibitor (PI) and Lenalidomide (Len) in the first line of therapy. For (1), sites were ranked using the lower 95% confidence interval for the percent of Black MM patients at the site. For (4), only sites with at least five MM patients who received PI and Len were included. Our data sources were: ConcertAI's Electronic Medical Record (EMR) and claims datasets to link each patient to a site, and Google maps API to identify the CAR-T center nearest each oncology site. The patients in our data sets were not identifiable, and our research was conducted in compliance with the Health Insurance Portability and Accountability Act. After having identified and filtered promising sites, we curated individual candidates in the order of Black patient density. The purpose of curation was to validate a final list of sites. Results: We identified 17 promising clinical trial sites affiliated with 16 healthcare systems in the mid-west, mid-Atlantic, southeastern, and southwestern regions of the United States (table 1). Our RWD captured an average of 141 MM patients (range: 6-791) who were treated at the 17 sites from 2015-2020. Thirty-nine percent of the patients were Black (range: 13-67%). This percentage was three times the recruitment rate of black patients in MM trials in the US (13%). On average, the sites were 44 miles driving distance (range: 0.8-96 miles) from the closest CAR-T center, had eight hematology/medical oncology specialists on staff (range: 1-17), and had previous interventional trial experience (13 sites had experience with MM trials). All of the identified sites were community-based sites, and none of the sites were previously identified by our pharmaceutical partner. Conclusions: We demonstrated that RWD can be leveraged to identify clinical trial sites with a high potential for Black patient recruitment, thereby addressing a known health disparity problem within multiple myeloma (MM) clinical trials. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

Case Report: Facial injury due to a firearm projectile in a Brazilian adolescent

Background: Deaths and injuries from firearms are significant public health problems. This article presents a case of face injury caused by a firearm projectile with atrial involvement. Case report: A 13-year-old male Black patient was admitted as an emergency victim of an accident caused by a firearm projectile. On physical examination, a hemorrhage was diagnosed in the right ear pinna region from the wound, and an increase of volume, of hardened consistency, in the right genic region, suggestive of local infection. On radiographic examination, a radiopaque, dense, foreign body was identified in the right zygomatic process region. The patient underwent surgery to remove the projectile. Conclusion: The care provided to the victim of a firearm injury depends on the systemic conditions, the available professional staff, the resources and the infrastructure of the environment. Prior to initiating therapy, it is important to stabilize the patient to ensure survival.

Study protocol for investigating physician communication behaviours that link physician implicit racial bias and patient outcomes in Black patients with type 2 diabetes using an exploratory sequential mixed methods design

IntroductionPatient-physician racial discordance is associated with Black patient reports of dissatisfaction and mistrust, which in turn are associated with poor adherence to treatment recommendations and underutilisation of healthcare. Research further has shown that patient dissatisfaction and mistrust are magnified particularly when physicians hold high levels of implicit racial bias. This suggests that physician implicit racial bias manifests in their communication behaviours during medical interactions. The overall goal of this research is to identify physician communication behaviours that link physician implicit racial bias and Black patient immediate (patient-reported satisfaction and trust) and long-term outcomes (eg, medication adherence, self-management and healthcare utilisation) as well as clinical indicators of diabetes control (eg, blood pressure, HbA1c and history of diabetes complication).Methods and analysisUsing an exploratory sequential mixed methods research design, we will collect data from approximately 30 family medicine physicians and 300 Black patients with type 2 diabetes mellitus. The data sources will include one physician survey, three patient surveys, medical interaction videos, video elicitation interviews and medical chart reviews. Physician implicit racial bias will be assessed with the physician survey, and patient outcomes will be assessed with the patient surveys and medical chart reviews. In video elicitation interviews, a subset of patients (approximately 20–40) will watch their own interactions while being monitored physiologically to identify evocative physician behaviours. Information from the interview will determine which physician communication behaviours will be coded from medical interactions videos. Coding will be done independently by two trained coders. A series of statistical analyses (zero-order correlations, partial correlations, regressions) will be conducted to identify physician behaviours that are associated significantly with both physician implicit racial bias and patient outcomes.Ethics and disseminationEthics approval was obtained from the Virginia Commonwealth University IRB. Study results will be disseminated through publications in peer-reviewed journals and presentations at conferences. A novelMedical Interaction involving Black Patients Coding Systemfrom this project will be made publicly available.