By Phyllis Kaplan and Joan Chambers, CISCRP
While the clinical trials industry has made incredible strides raising awareness among the broader general population, as we’ve witnessed firsthand amid the ongoing COVID-19 pandemic, there remains a persistent lack of representation in clinical research among diverse communities.
For decades, people of color have largely chosen not to participate in clinical trials. Stemming from a disturbing history with clinical research that resulted in a deep distrust in the healthcare system, these hesitations and concerns have only recently begun to be addressed by the clinical trials industry.
In addition to acknowledging the lack of representation, three key aspects of patient recruitment need to be addressed to make sure all patients are accounted for and considered. Otherwise, both clinical research and patient communities will ultimately suffer.
1. Identifying The Importance Of Representation Across All Clinical Trials
It is clear that diverse participants have been significantly underrepresented in clinical trials; however, making sure clinical research reflects a representative group of patients is integral in providing solutions and alternative treatments. If not, seemingly groundbreaking discoveries pertaining to specific health conditions will be proven to be effective for only a fraction of patients.
For example, the FDA’s 2018 Drug Trials Snapshots showed that of the more than 5,000 patients who participated in oncology trials, only 4% were Black. Yet, collectively, the Black population has the highest death rate and shortest survival of any racial or ethnic group in the United States for most cancers.
The COVID-19 pandemic brought this disconnect to light again. For example, early in the pandemic, researchers discovered that the COVID-19 virus was disproportionately affecting communities of racial and ethnic minorities, with Black COVID-19 patients nearly three times as likely to be hospitalized as compared to non-Hispanic white patients. With this massive disparity emerging, it became even more crucial to include people of color in ongoing COVID-19 research to not only understand why this was happening but also ensure the vaccines in development were just as effective for Black patients as the rest of the population.
Ultimately, clinical trials and the results yielded from years of research suffer without fair representation. To address this issue specifically, continuing to broaden eligibility criteria in clinical trials through inclusive trial practices and designs will be crucial in ensuring representative population splits within the patient pool, along with new initiatives to impose mandatory patient population totals or percentages across all types of trials.
2. Boosting Retention By Eliminating Barriers
Patient retention in clinical trials has long been an issue. In fact, more than 30% of drugs entering Phase 2 studies fail to progress because of patient dropout. This could be due to a number of reasons, often involving inconvenient logistics (like transportation) and overall health and safety concerns, especially in the face of COVID-19.
When speaking about areas of health concerns, Black patients report more hesitations when considering participation in clinical trials and a greater desire for safety precautions if they were to participate compared to white patients. Overall, 77% of patients of color report that concierge services are important in easing COVID-19 concerns in a clinical trial as compared to 61% of white patients. And 80% of patients of color identify the ability to communicate with a study doctor remotely as important, compared to 72% of white patients.
Therefore, to make sure patients – particularly diverse patients – are on board from start to finish, research sites need to adopt more patient-centric practices to provide comfort and accessibility for participants. For example, if a research site is off the beaten path or not near a transportation hub, the site should implement transportation services to help with appointment logistics. Or if the patient is concerned about in-person visits due to possible COVID-19 exposure, site staff should reevaluate whether a visit is essential or if it can be completed virtually through telehealth services.
It is also important that researchers engage in effective communication and remain as transparent as possible throughout a clinical trial. This can be done by way of weekly newsletters, frequent phone calls, and personal emails to ease any hesitations and to provide a patient with the latest updates on how those expectations are consistently being met. Ultimately, sites should be in constant contact with patients to ensure their needs are addressed and in case they experience any conflicts in treatment.
3. Engaging In Widespread Education And Awareness
While distrust and barriers to participation are issues for prospective participants who are aware of clinical research, many individuals might not even be familiar with the clinical trial process in general. What’s more, in today's media environment and the constant COVID-19 news cycle, misinformation on clinical research and the current vaccine trials makes it difficult for patients to distinguish between what is reliable information and what is not – oftentimes being presented with news that could potentially curtail future involvement in research.
To help dispel misconceptions and potentially ease some of the existing distrust in the healthcare system as a whole, broad-based educational efforts should be implemented to increase awareness of clinical trials across diverse communities.
This means that efforts like live or virtual events can be created to invite community members across the country to learn and become more informed about clinical trials, detailing how clinical trials work, what trials are available nearby, and how they can get involved. And although COVID-19 has provided an obstacle for in-person events, we’ve learned that virtual participation can be just as strong and effective.
As an example, CISCRP’s 2021 AWARE for All virtual event series, which runs until November 2021, focuses on informing the general public about the clinical trial process while incorporating conversations by real-life participants and local medical professionals. The series, which is segmented into five separate events across all U.S. regions with AWARE for All – Northwest happening next on May 20, is expanded to reach local community members and engage diverse communities. By engaging in this form of broad-based education while targeting regions to ensure that all areas, especially diverse communities, are being covered, the industry can work to transform the sentiment toward clinical research while providing helpful resources.
The Industry’s Efforts Moving Forward
As we’re seeing a significant increase in interest around clinical trials throughout the pandemic, we’re also seeing a rise in hesitation and concern, specifically among communities of color. It is the healthcare industry’s responsibility to ensure everyone is represented in clinical research and that any misconceptions continue to be addressed among the general population. Though it will require combined and concerted efforts from organizations across the clinical research industry, we’re far from short on tools and initiatives to drive real change.
About the Authors:
Phyllis Kaplan, senior manager, events and community engagement, CISCRP, brings more than 12 years of project and program management experience spanning across several industries, including consumer electronics and educational publishing. She currently oversees the development and operations for CISCRP’s community engagement programs, including the AWARE for All event series.
Joan Chambers, senior director, marketing and outreach, CISCRP, has more than 20 years of experience in the healthcare and life sciences industry, providing marketing counsel to a wide range of industry professionals in addition to frequently speaking at national events and conferences focused on health care. She currently develops and executes strategic marketing, promotions, and outreach for CISCRP, along with helping launch new initiatives for continued growth opportunities.