Through this program, Dr. Buie and colleagues have found that adapting the Lupus Conversations model proved effective in increasing knowledge among nurses. They also found that nurse-led interventions and patient follow-up are key to understanding the overall effectiveness of such educational programs as IMPACT+.
Big Pharma
The session’s final panel discussion focused on the role of the pharmaceutical industry in supporting the diversification of clinical trials. The first speaker was Sergio Arce, MD, PhD, medical director, global clinical development, autoimmune diseases, RemeGen Biosciences, San Francisco.
Dr. Arce noted that racially and ethnically distinct subgroups of the U.S. population often respond differently to medical products. These differences are likely due to such factors as genetics, metabolism, drug elimination, diet, environmental exposure and socioeconomic variables—among other things. This underscores why minority participation in clinical trials is important—to properly understand treatment efficacy and safety in different patient populations.
With this in mind, Dr. Arce discussed a clinical trial of telitacicept and the plan to focus on minority recruitment in the trial.3 As part of the plan, researchers are using a patient-centric approach and outreach to the minority community, ensuring patient education materials are easily accessible and the website is patient-oriented, as well as including involvement of church and religious leaders in the community. From a global perspective, the focus is on enrolling subjects from varying geographic regions, such as Central and South America and Asia.
For this clinical trial, a stratified block randomization method will be used, with stratification factors that include region. Additionally, researchers will do a subgroup analysis for pharmacokinetics, pharmacodynamics, efficacy and safety end points across patients of different races, ethnicities, sex and ages.
Next, Coby Hobar, MD, clinical development lead, Bristol-Myers Squibb, Tampa, Fla., discussed several barriers to clinical trial participation for under-represented patients. From the standpoint of clinical trial sponsors, their understanding of the effect of trials on a patient’s daily life may vary. They may also have limited interest in involving inexperienced sites and investigators in a trial, even if it increases the diversity of participants. They may also lack direct communication with sites about the needs and importance of diversity in a clinical trial.
For research sites, expensive start-up costs, lack of diversity among investigators and clinical staff, bias in which patients are referred to clinical trials, and lack of community engagement may all play a role in contributing to the problem. Thus, Dr. Hobar noted the biopharmaceutical industry has promised to commit to working with patients, advocacy groups, regulatory authorities, healthcare providers, academics and policymakers to define systematic and impactful approaches to enhance the diversity of clinical trial participants and help reduce healthcare disparities.
