Diversity of clinical trial participation in early-phase clinical trials at WCCT – an opportunity to translate successes to late-phase clinical trials
In 2020, there has been a heightened awareness of the need for planning and implementing strategies and tactics to ensure that there is an ethnic diversity in the participation of clinical trials. Our industry has received much scrutiny amidst the ongoing pandemic by regulators and patient advocacy groups on the design and analysis of clinical trials for COVID-19 interventions as they relate to ethnic inclusion. The reason for this heightened awareness and subsequent scrutiny is that the metrics published by industry of ethnic enrollment in Phase III COVID-19 studies showed that the sponsors needed to hone their diversity strategy midway through the studies to accelerate the rate of ethnicity enrollment, as ethnic populations targeted for commercialization were under-represented.
In response, on Nov 10, 2020, FDA announced availability of updated guidance for industry, entitled: “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices and Trial Designs.”
WCCT Global recognizes this important issue and we take ethnic inclusion very seriously when planning for recruitment activities in studies we conduct with our CRO & sponsor partners. We focus on conducting early clinical trials that generally are testing the safety, tolerability, bioavailability, and immunogenicity of investigational biopharmaceutical products.
Interestingly, the outcomes of ethnic inclusion and study enrollment we witness are in contrast with the outcomes of late-phase studies that sometime struggle to successfully meet diversity recruitment goals, and we present some of WCCT’s outcomes within this article.
A snapshot of our recruitment, screening and enrollment metrics through January 1st – December 10th, 2020 are as follow:
- Appointments: Total 6,121 appointments made
- Screenings: Total 5,555 screenings conducted
- Dosing: Total 1,715 confirmed for admission
When collecting ethnicity data during the recruitment and engagement process, WCCT generally follows the Office of Management and Budget (OMB) Directive No. 15 Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity (October 30, 1997, updated on Nov 19, 2019), available here.
We show above that WCCT’s recruitment team successfully creates interest, recruits, screens, and enrolls racially diverse populations into early clinical studies, which does help meet our Sponsors’ objectives of learning of the safety and tolerability within such populations.
We know our clinical site is located in the second largest metropolitan area within the United States, and that we have access to a large ethnic population to which other clinical sites in other areas of the country don’t have access, however, we don’t know the reason(s) why study participants are interested in participating. How we translate that interest from our study volunteers to help recruitment strategy for late-phase studies is something that needs to be explored, and WCCT endeavors to do this in 2021.
Even without such knowledge as to why someone volunteers for a clinical trial, there seems to be an opportunity for industry to leverage the ethnicity participation outcomes that WCCT and other early clinical CROs & Sites capture to help educate ethnic populations during late-phase study recruitment campaigns. Use of data collected related to intrinsic and extrinsic factors, presented in laymen’s term, may help overcome some perception in general and within specific ethnic populations about the safety risk of participation in clinical trials. Specific discussion topics presented by individuals with ethnic backgrounds (within industry) directly to targeted ethnic populations and their health care providers on the safety of the product once it reaches late-phase development and commercialization may enhance diversity in clinical trials.
Community connections are important – several sponsors have created corporate ethnic diversity initiatives and teams. WCCT welcomes members from these sponsors’ teams to participate in our ongoing community outreach to give sponsors an opportunity to help create trial participation awareness. Sponsors can witness first-hand what perspectives and sensitivities are involved in shaping the interests of ethnic populations that result in participants entering the recruitment process for early clinical trials. This insight may help in developing the strategies that can overcome lack of diversity of clinical trial participants in late-phase studies and even during commercialization to ensure that adoption of the important medicines is maximized.
WCCT Global’s recruitment team will continue to ensure that we structure our database of interested subjects with a high level of granularity of demographic and racial data for ease of creating feasibility reports. Our physician relations team and patient recruitment vendor management team will continue to prospectively work with stakeholders in the recruitment process to further ensure feasibility efforts are meeting racial enrollment requirements. We will also strive to continue our industry leadership position in creating value for sponsors through ethnobridging services and study conduct so that we can always participate in industry-led conversation about diversity in clinical trials.