Clinical trial professionals are keenly aware that there is a serious need to improve the representation of racial and ethnic minorities in their studies. Doing a better job of reaching underserved populations in studies can lead to a number of benefits, including faster study startup, more efficacious therapies, and improved outcomes for patients in these groups.
Outsourcing-Pharma connected with David Coman, CEO of decentralized clinical trial specialist Science 37, about issues surrounding underrepresentation, as well as solutions that could reduce the gap.
OSP: Inclusivity continues to be a concern in clinical trials—could you talk about some of the ways in which clinical research professionals have tried to narrow the gap, and maybe what has worked and what’s been less successful?
DC: Now, more than ever, we are seeing an openness and willingness by the clinical research industry to shift the paradigm and take meaningful action to reach patients who need it most. For us to properly address this challenge, we must implement a multi-faceted approach to drive transformation.
From our experience, we’ve observed success when a holistic lens of the patient journey is incorporated into the clinical research process. It’s imperative for clinical research professionals to ask the tough questions regarding how underserved populations access healthcare – and unite this understanding with a commitment from all key stakeholders to implement the requisite changes to foster success.
For example, we’ve observed a meaningful impact on improving real-world patient representation in studies where sponsors begin with inclusivity top of mind, commencing with study design. Protocols that support meaningful clinical endpoints—and are also written to improve representation and support the patient experience—tend to do best.
We’ve seen greater representation in studies and accelerated enrollment from diverse communities when trials are designed in such a way that can help meet patients where they are. Moreover, when we’ve been able to connect and invest in trusted providers in the underrepresented communities we wish to serve, deploy technology to properly educate and activate diverse patient populations—and, more importantly, meet patients where they are via our specialized networks—we’ve seen tremendous success.
Conversely, we've observed that health equity initiatives flounder when stakeholders aren’t aligned on the aspects of change management that are imperative for success, i.e. when studies are designed in such a way that only a select few can participate or due to the rigor of procedures required in inconvenient locations. We appreciate that it is a significant undertaking to deploy inclusivity initiatives. However, whenever possible, we believe it’s imperative to avoid undertaking haphazard transactional initiatives—when deployed in these communities, they can cause undue harm and oftentimes stymy hard-won progress.
OSP: The disparities in inclusivity, as you know, are not the same across all conditions. Could you please talk a bit about the gaps between Black and white patients when it comes to breast cancer?
DC: The prevalence of breast cancer, and the mortality rates of patients, differ between ethnic groups. While new cases of breast cancer are about the same for both Black women and white women, incidence before age 45 is higher among Black women, while between ages 60 and 84, it’s much higher for white women. Yet, Black women are more likely to die from breast cancer in every age group.
Poverty is a critical factor and is associated with poorer breast cancer outcomes for all Americans, but because a greater proportion of Black women live in poverty, they are more likely to have a higher mortality rate from breast cancer. A major barrier is the lack of access to a primary care physician, as women with a regular provider are more than twice as likely to undergo mammography screening.
Geographical barriers also play a role, of course, with screening, diagnosis, and treatment becoming difficult when primary care clinics are not easily accessible, especially in economically deprived areas. And so, women in underserved communities may be required to travel long distances and put up with long waiting times. Moreover, it is often difficult for disadvantaged women to prioritize prevention and screening activities ahead of pressing needs like food, shelter, and security.
OSP: You mention that improving inclusivity benefits more than just the patients from minority groups who are seeing their representation increase. Could you please share your thoughts on how increasing representation leads to benefits for sites, sponsors, and other stakeholders?
DC: At a basic level, increasing diverse representation in clinical trials is the right thing to do, and whenever you do the right thing, all stakeholders tend to benefit. From a clinical perspective, there is a greater urgency from sponsors and even regulators to enroll study participant groups that more closely represent real-world patient populations.
Therefore, by increasing accessibility and thereby diversity, trials are able to meet the requirements of sponsors and the FDA. And, of course, we are helping to bring treatments to market that have been tested on a more representative population and are, therefore, more effective to more patients in the real world.
While the rest of the industry has struggled to enroll people of color, who are represented at about one-third of what should be scientifically accepted, Science 37 is enabling universal access to clinical research and is achieving three times the participation rates. Not only are we enrolling a more representative sample of patients in our studies, but we’ve also been asked to be highly targeted at engaging many of the underserved patient populations.
As an example, we recently conducted a blood assay study for cancer screening that is aimed at detecting all cancers. We offered a flexible approach to quickly access a more representative patient population through the Science 37 patient and provider communities, resulting in faster enrollment and increased diversity. We exceeded the enrollment forecast by 275% over eight weeks, and crucially, we surpassed the study’s diversity goals with 56% Hispanic samples. So, we were able to accelerate the development of less-invasive diagnostics to help detect cancers sooner—and every stakeholder benefits from that!
OSP: Please talk about how Science 37 has helped its partners improve representation for trials in general, but also for studies specifically aimed at breast cancer treatments.
DC: Earlier this year, Science 37 created a dedicated business unit focused on working with sponsors and other partners to empower diversity in clinical trials. In addition, we are continuing to build out our Diversity Therapeutic Network, where we are identifying and recruiting physicians as study investigators and offering them a platform into clinical research, which in turn enables us to enroll more diverse patients into studies through them. We have also launched the industry’s first Diversity in Clinical Research Foundation to divert funding towards increasing representation in clinical trials.
In terms of a case study in breast cancer, we ran a COVID-mitigation trial for a subcutaneous formulation extension, where we were able to help patients stay on treatment by bringing the trial to their homes during the pandemic. We were able to get the study up and running four times quicker than the sponsor had experienced previously. A mobile nurse would visit their home to administer the treatments, and we also deployed electronic outcomes assessments and telemedicine follow-ups.
This study got great feedback from both the sponsor and patients, who were excited to be able to stay on therapy. We literally had patients dancing with our nurses in their living rooms.
OSP: Do you have any additional advice for trial teams looking to increase representation for their studies—for cancers and other conditions?
DC: I would advise clinical research sponsors to think beyond traditional clinical trial designs to improve access for patients. Via our operating system, we have been able to enroll three times the percent participation among people of color – simply because we aren’t reliant on traditional sites that exclude populations due to geographic proximity. The Science 37 model enables universal patient participation—anyone, anywhere.
If you’re more comfortable with a traditional approach to clinical trial design, I would also advise evolving to an agile approach to start taking advantage of the benefits of decentralization. An easy way to get started is to establish a Metasite, or virtual site, to supplement your traditional site network. This not only provides the benefit of familiarity but also can accelerate enrollment across the board while ensuring inclusion among underserved patient populations.