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Embarking on a journey through the ever-evolving landscape of clinical patient recruitment, it is important to understand the intricacies of patient recruitment strategies, placing a spotlight on the transformative waves of diversity, equity, and inclusion (DEI) within the clinical space. Inclusivity in clinical trials is an ongoing pursuit, so as an industry, it is crucial to understand the challenges and triumphs of DEI in the clinical space.
While initiatives during the COVID-19 pandemic brought short-term visibility to clinical research with vaccine development and deployment across a broad and diverse spectrum of people globally, some of the positive efforts seem to have dissipated since then. This emphasizes the ongoing need for education and community engagement. However, some of the positive impacts of decentralized clinical trials remain, as they are still used today to help improve patient accessibility.
One of the biggest challenges are barriers in early patient recruitment for Phase I and II studies. Sponsors often deal with budget constraints and lack of understanding of patient epidemiology and behaviors, while healthcare providers face time constraints, potential biases against recommending clinical trials, and lack of resources to enable staff to learn and understand any new treatments on the horizon.
This all does harm when it comes to successfully recruiting diverse patients for these types of trials early on, which is why intentional planning is key. A recent FDA guidance is encouraging that submitted studies have a plan to ensure diverse participation in clinical trials. The guidance emphasizes the need for a comprehensive approach that encompasses various dimensions of diversity, including race, age, sexual orientation, and addressing the needs of those with disabilities—all of which should be considered early on.
There is an interconnection between time and budget constraints, as the industry pushes to meet deadlines more quickly. These two factors can negatively impact the ability to recruit accurate and diverse patient populations. For example, even during the COVID-19 pandemic, Moderna took a rare pause in enrollment to ensure minority representation, emphasizing the importance of taking time to do things right.
Improving the Patient Experience
According to a recent survey finding conducted by Advanced Clinical, more than 70% of patients are either unsure how to participate in, or unaware of, clinical trials. This underscores the need for strategic approaches to raise patient awareness, ranging from more educational online content and social media posts to radio and TV advertisements to reach more potential patients. An example from Advanced Clinical is their partnership with an AI-powered health crowdsourcing company to directly connect with patients in specific health-focused communities, bringing clinical trial awareness to the forefront.
During the clinical trial, it is important the patients have a “frictionless journey,” which can be done with integrating technology and implementing patient-centric approaches. Streamlining the clinical trial process, making it easier, simpler and quicker for patients from identification through participation and completion, is the ultimate goal.
Building a Single Source of Truth for All
In the future, a single source of truth for healthcare providers and patients could significantly simplify the search for clinical trials. From the Advanced Clinical survey previously mentioned, among rare disease respondents, they expressed the need for a centralized platform, providing reliable and easily accessible information in a user-friendly manner.
This also needs to be publicized amongst the public and especially with medical professionals to help raise better awareness for clinical trials and tools that may help patients find the right trials. Having this single source of truth could immensely help recruit and engage more diverse patients in clinical studies, but until then the clinical trial industry is making progress slowly but surely in the face of many challenges to still overcome.
About the Authors
Tracy Parker, VP of Biometrics, Advanced Clinical, Advanced Clinical.
Rebecca Starkie, Senior Global Patient Engagement Director, Advanced Clinical.
