As part of our Crystal Ball series, we asked BBK Worldwide President Matt Kibby to share his predictions for 2021, which include engaging underrepresented populations in clinical research.
Matt Kibby, Principal, President
Is there a particular trend that you expect to have a significant impact on the industry in the coming year?
With COVID-19 dominating the headlines for much of 2020, one might expect that a key development for clinical R&D in 2021 will be the continued integration and expansion of services that support the hybridization / decentralization of clinical trials. Keeping trial participants – who tend to be older and at greater risk for complications from COVID-19 – away from clinical trial sites not only reduces the risk of SARS-COV-2 infection, but also offers the possibility of enrichment of the clinical trial experience; reduces the overall visit and expense burden for patients; and, moreover, reduces the trial burden on clinical trial site healthcare professionals.
And yet . . . I feel that the positive news about vaccines from Pfizer and Moderna (while very welcome!) may inhibit some of the progress that the industry is making. The visible end of the pandemic, coupled with the cost burden of true patient centricity and a relative lack of ROI data for embryonic services, may give pharma reason to wonder whether they should pull back on the reigns before fully committing to this approach. No doubt there will be an accelerated adoption of these services above and beyond what would have occurred without the pandemic, but the unprecedented speed and success seen in advancing a vaccine may give pharma pause when green lighting fundamental and potentially expensive changes.
As such, I think that the issues surrounding inclusiveness, social and racial injustice, diversity in medicine, and the underrepresentation of certain populations in clinical research may just bubble up as the strongest drivers of change in our industry in 2021.
Indeed, in November 2020, the FDA published “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry” which brings to the fore our need to do more to recruit and retain patients from traditionally underrepresented trial populations.
The document is not only meant to address the inclusion of minority populations such as Black, Native, and Asian Americans, but also to advocate for other populations that have been overlooked historically, such as women, older adult populations, clinically relevant populations, pregnant women, and participants with rare diseases. Additionally, the guidance document specifically addresses the need for broadening the eligibility criteria in study protocols to increase diversity and include a more representative sample of patients for whom the study drug would be ultimately intended; reducing the burden of participation in clinical trials; and adopting recruitment practices that enhance inclusiveness.
As if to amplify this signal for inclusiveness, an article just released in the scholarly journal Cell Systems reveals that Massachusetts Institute of Technology (MIT) used machine learning to discover gaps in genetic diversity coverage for the Pfizer, Moderna and other COVID-19 vaccines. In fact, in a press release issued by MIT, David K. Gifford of the Computer Science and Artificial Intelligence Laboratory said “our preliminary results suggest that, on average, people of Black or Asian ancestry could have a slightly increased risk of vaccine ineffectiveness.”
A stinging fact that I can personally validate is that when it comes to recruitment and retention for clinical trials, pharmaceutical companies are still largely driven by the question of return on investment. How can they maximize recruitment into the study for the lowest possible recruitment investment? Can they force recruitment companies into being reimbursed not for overall efforts or work performed, but for patients randomized into the trials? Sometimes this will mean that the specific recruitment of underrepresented populations will be further depressed because why would a recruitment company go after harder to recruit patients if they were only being reimbursed per patient randomized? Or, at a bare minimum, place upward pressure on overall recruitment costs and consequently lower the ROI? Big pharma needs to come to terms with this truth before it can properly address the imbalance of recruitment in trials.
In our clinical trial work for the past 20 plus years, BBK Worldwide has always been at the forefront of promoting broader inclusiveness in clinical trials. This is particularly true when it comes to understanding the patient population that will most clearly benefit from participation and offering consultative feedback to the industry on protocol eligibility criteria that offer more chances for inclusion.
I hold great hopes that 2021 and beyond can begin to see real change in the right direction.
Please see part two of this post for predictions from more of our industry experts.