Despite robust product development efforts, there is still a considerable gap between patients and physicians needed in clinical research and those actually participating. The recent shift and re-prioritization of improving minority representation in clinical trials only accentuates this challenging reality.
As noted in FDA’s recent draft guidance centered on enrolling more diverse populations, “clinical trials provide a crucial base of evidence for evaluating whether a medical product is safe and effective; therefore, enrollment in clinical trials should reflect the diversity of the population that is ultimately going to use the treatment.” Even though racial and ethnic minorities continue to be disproportionately impacted by certain diseases, the participation of these populations continues to be underrepresented in biomedical research. Although distrust is a significant barrier to diversity in clinical trials, it is often overlooked that engaging and empowering physicians in these communities can increase trust, which is essential.
To do so, clinical research partners must intentionally expand their reach to include investigators serving the people within these diverse and often underserved communities. This should be non-negotiable and integral to every research project plan.
Within racially and ethnically diverse communities, there is a longstanding mistrust surrounding clinical research and experimental medical advancements due to the historical abuse of nonconsensual patients in clinical studies. One of the fundamental ways we can help address this mistrust is through close partnerships with community-based physicians. Physicians often need the training, support, and resources necessary for conducting clinical trials. By providing them with the tools they need, investigators are more likely to further their clinical reach and engage in research, knowing they will have less burden and more time with their patients. In turn, we also gain access to more patients, resulting in greater diversity in clinical trials and improved healthcare options for those in underserved communities.
In traditionally marginalized communities, the rapport and connection of local physicians are invaluable. These providers might be a patient’s neighbor, belong to the same church, or have children in the same school. Frequently, these providers have deep roots in the community and have a better understanding of their unique needs, available resources, as well as social and economic challenges. Providers in underserved communities of this nature play a unique – and vital – role in enabling access to clinical research for their patients. By leveraging the existing trust and connectivity, providers can help patients understand the value and improved care options that clinical trials offer. Clinical research partnerships bring value to community physicians by allowing them to use research to achieve population-based health goals. At the same time, research interaction with patients is a high-touch, concierge type of care. Physicians can spend more time with patients one-on-one, and patients feel well cared for with added attention.
Physicians and patients involved in clinical research often discover a common bond in the shared goal of contributing to the advancement of science. As an investigator, physicians provide support and guidance to their patients. Having the opportunity to contribute to the advancement of healthcare while improving patient care through clinical research can lead to added meaning and an elevated sense of gratification for physicians.
By engaging in clinical research, investigators also invest in themselves by developing a new skill set for their day-to-day practice. It can help them achieve professional goals and open new doors, expanding their options as they progress along their career path. Successful trial delivery requires integrated approaches to research and right-fit trials. This means ensuring that investigators are matched with study opportunities that fit their interests and objectives and the needs of the patients they serve.
Maintaining relationships with investigators
Communication is key to ensuring investigators get involved in clinical research and stay involved. For example, the study requirements must make it as easy as possible for providers to fit clinical trials into their daily routines. To maintain physician engagement, it is crucial to solicit regular feedback and respond as soon as possible. Staying abreast of their needs supports engagement and strengthens relationships. Using surveys can help evaluate investigators’ capacity and desire to be involved in new trial opportunities, as well as help increase their contribution to clinical research by providing insight into additional areas of interest and opportunity.
Recognition is also a huge part of maintaining positive relationships and retaining investigators. It is essential for investigators to feel appreciated, acknowledged, and valued by their research partners. For example, I like to send a note or a small thank-you gift to our investigators when they enroll their first patient or meet or exceed trial enrollment. Additionally, as part of an anniversary recognition program, we make a donation to a nonprofit in their honor. We also recognize an Investigator of the Year to celebrate an outstanding partner who excels in delivering clinical research as a care option and who has demonstrated their commitment to exceptional patient care.
Physician engagement and empowerment are vital to addressing the current unmet needs in the clinical trial pipeline for investigators and patients. Providing investigators with a strong infrastructure, top-notch support with day-to-day boots on the ground, and powerful, continuous training makes for solid and successful relationships. When we bring physicians from underserved communities into research through a reimagined model, we can impact better health outcomes rooted in quality data that allows us to thrive from more diversity and better representation while providing patients with greater access to new care options.
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