Last week’s SCRS Diversity Site Solutions Summit provided a timely convening of clinical research stakeholders for important discussions on sustainable practices to expand the engagement, recruitment, and retention of diverse patient populations in clinical trials. Improving diversity in clinical research is our purpose at Alcanza Clinical Research, and a public health imperative, to ensure safe and effective medicines for all.
At the second annual event, I was pleased to see increased attendance from 2022, particularly from sponsors. Having the privilege of joining distinguished speakers and participating in the panel discussion How are YOU Defining Diversity with Angel Akinbinu of Syneos Health, Dr. Lovie Negrin of Randomize Now Research Centers, Betsy Wagner of IQVIA, and David Windsor of Pfizer, I’m encouraged by the energy and collaboration, but also recognize where we need to accelerate our efforts to make a meaningful impact:
- The research community must align on global definitions for diverse trial populations, and how trial diversity can be measured. There’s a need for broader ethnic categories and more work into how participants want to report their race and ethnicity, especially with the rising prevalence of multiple ethnicities.
- Diversity initiatives are still mainly focused on race and ethnicity. This is a clear regulatory priority, but inclusive clinical trial participation has far-reaching implications, including age and gender inclusion, elderly populations, disability, and socio-economic status, among other considerations.
- We are only scratching the surface when it comes to reducing barriers to participation. This is a complex issue of education, awareness, motivation, and convenience. Consistent implementation of access initiatives and community outreach engagement will likely remain for decades to come. Today, sponsors are beginning to rethink traditional standard – and medically unnecessary– exclusion criteria, such as body mass index (BMI) or restrictive lab values. Adhering to outdated practices can inadvertently exclude large demographic groups.
- As an industry, we focus on patients, but diversity initiatives need to start in the workplace. Expanding the diversity of trial participation requires having diverse investigators. It also requires building diverse workforces and organizational cultures.
- Fair compensation for patients is an overlooked issue, especially with global inflationary pressures. Potential participants who take the time to attend a screening visit should be adequately compensated for their time even if he/she does not qualify for a study, with compensation that matches minimum wage. Trial stipends need to be adjusted by 30% or more for inflation.
- Decentralized trials (DCT) have a lot of promise, but the configuration and execution are still maturing and need to be carefully considered on a study-by-study basis. DCT components should be presented to sites and patients as optional. Broad preference for telehealth and home health remains to be seen. Without patient-level support, DCT technology adds to the current site burden.
Collaboration among sites, CROs, sponsors, technology vendors, and patients everywhere is a critical theme for the future, especially as the industry prepares for final guidance and additional reporting expectations from FDA and other regulatory agencies. Events like the Site Solutions Summit reinforce why knowledge-sharing, transparency, and innovation are so critical to advance inclusive research and, ultimately, health equity.
Carlos E. Orantes
CEO, Alcanza Clinical Research