Background The prevalence of systemic lupus erythematosus (SLE) is substantially greater among racial and ethnic minorities. However, marked gaps exist between populations affected by SLE and those enrolled in clinical trials, even large-scale multicenter and multinational trials.1, 2 A lack of diverse populations in lupus clinical trials results in an evidence base that is less generalizable to underrepresented patients who may be more severely impacted by this disease, further exacerbating existing health disparities.2, 3 In order to cultivate a culture to integrate clinical trials in clinical care settings, we must strive to equip clinicians with the motivation, skills, and proficiency to inform and encourage effective conversations with diverse patients about lupus clinical trial participation. We aimed to explore available evidence on the importance of and approaches for patient-clinician communication around clinical trials and outline opportunities for future research to advance clinician communication around lupus clinical trials.
Methods Based on a review of the available evidence, we provide an overview of: 1) the state of diversity and representation in lupus clinical trials; 2) the critical role, responsibility, and potential clinicians have in integrating lupus clinical trials into lupus clinical care; and 3) expert-informed guidance and opportunities for future research to improve diversity and representation in lupus clinical trials.
Results There has been limited attention given specifically to clinical trials discussions in communication programs developed for providers,4-7 and to our knowledge, none specifically tailored to improving clinicians’ communication skills to improve conversations with racially and ethnically diverse patients with lupus about participation in clinical trials. In order to cultivate a culture of research in clinical practice, early exposure and training for clinicians is critical to impart understanding and a sense of importance of the potential opportunities for patients to benefit from clinical research.8 Clinician communication with patients has been identified as one of the most effective approaches to increase enrollment in clinical trials and healthcare research,9 and many patients expect and prefer their treating physicians to inform them about clinical trial opportunities.10, 11 As there is no formal training pathway for trainees or clinicians who want to become more involved in clinical trials, or wish to pursue a career as a clinical trialist, there is a clear need to provide such opportunities. Academic medical settings present multiple advantages to care and research (e.g., subspecialty expertise and training, clinical trial infrastructure).12 Thus it is critical that trainees and clinicians are provided with education, training, and practical experiences such as apprenticeships with experienced investigators to learn about clinical investigation. Clinicians can adopt a ‘universal precautions’ approach to lupus clinical trial discussions in the context of clinical care.13 Such an approach can address clinician implicit biases and ensure that all potentially eligible patients are provided the opportunity to make informed decisions about participation in a lupus clinical trial. Additional education, training, and support are needed to equip clinicians with the skills to carry out effective clinical-trial discussions with patients, such as verbal and nonverbal skills training, cultural competence, and implicit bias training (table 1).4, 14-18 Improved patient-clinician communication can in turn increase trust in the clinician, build rapport, and improve patients’ consideration of participation in lupus clinical trials.5, 19, 20
Conclusions Improving equity in patients’ opportunities to participate in lupus clinical trials is essential to address disparities in clinical trial participation, and ultimately improve health outcomes. In order to cultivate a culture of research in clinical practice and improve diversity and representation in lupus clinical trials, it is critical that we integrate formal training and learning opportunities for trainees and clinicians who will care for patients with lupus. Research is needed to understand and identify best practices to support effective patient-clinician communication to facilitate patient engagement and participation in lupus clinical trials.
Acknowledgments Abstract presented on behalf of the Chapel Hill Alliance Promoting Excellence in Lupus (CHAPEL) group of investigators. We would like to acknowledge individuals living with lupus for their courage and determination, and clinical trial participants for their contributions to science and efforts in advancing health and healing for all.
Lay Summary There is an urgent need to improve the participation of racially and ethnically diverse participants in lupus clinical trials to ensure that the products from clinical trials are safe and effective for all patients. Clinician communication with patients has been identified as one of the most effective approaches to increase enrollment in clinical trials and healthcare research.
However, there is no formal training for trainees or clinicians who want to become trial investigators or more involved in clinical trials. There is a clear need to provide such opportunities for both practicing clinicians and trainees to build knowledge and skills around having effective conversations with patients about lupus clinical trials and provide all eligible patients with the opportunity to make decisions about participation in a clinical trial.
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