Contributed Commentary by Sondra Pepe, AiCure

Clinical research should be a viable option for everyone who wishes to participate. Sponsors know that diverse trials lead to stronger data and better drugs, yet there are many obstacles to recruiting and retaining diverse participants – from distrust, to lack of access, to financial and logistical barriers.  

The promising news is regulatory bodies are addressing these issues, evidenced by the Food and Drug Omnibus Reform Act enacted late last year, which required sponsors of any phase 3 trial to submit a diversity action plan. We’ve also seen progress in the oversight of AI-powered tools used in clinical trials to ensure they are built on diverse data and safe for all patients to use, as seen with the FDA’s latest draft guidance on submissions for AI-enabled devices.  

While these are important steps, much is still left in the hands of sponsors and sites to truly close the gap. There needs to be a human-centric approach that starts with data-driven recruitment of the right patients, publicizing research options more equitably, and reducing the burden of participation once enrolled.  

More Targeted Recruitment Through Cleaner Data 

The disparate nature of health data causes many headaches for sponsors and healthcare providers alike, but one of the consequences is a barrier to effective patient recruitment for research. Evolving how we manage patient records in traditional healthcare settings will enable an accurate, holistic picture of a patient, creating an accurate profile to compare against inclusion and exclusion criteria for trials. Today, patients get invited to studies that are irrelevant to them, wasting time and resources and potentially furthering distrust in clinical trials.  

Improving data-sharing and connecting disparate data systems across clinical research and healthcare allows us to identify the right patient at the right time. While interoperability is a decades-long work in progress, creating a fully connected healthcare ecosystem will drive personalization across the care continuum—from patient care through participant recruitment.  

Advancing Transparency and Accessibility Surrounding Research 

Beyond identifying the right patients, there is inequity in which patients are given the opportunity to participate. For many, clinical research can be a final, lifesaving option of care. When a patient and their doctor arrive at a point where there’s no other option beyond enrolling in a clinical trial, doctors can be wary to discuss clinical trials that aren’t offered through their own institution, leaving patients on their own in the hunt to seek alternative options. This approach is inequitable in itself; the clinical research landscape can be complex to navigate, and it requires education, resources, and a strong network to effectively explore trial options. 

Providers need time to share research options and clarity around their ability to speak about research options outside of their institutions. At a minimum, providers should equip patients with the tools and resources of where to look, directing them to patient advocates or clinical trial search services and technologies. 

Improving Convenience and Engagement 

The personal and financial cost of participating can also be limiting factors. Garnering interest from diverse participants requires meeting them where they are with flexible research options that allow them to fit a clinical study seamlessly into their work and family life. Especially for research studying more manageable conditions, it’s difficult for a person to justify taking time off work or paying for childcare when it isn’t a life-saving measure. Lowering the burden can look like free childcare services, free transportation to the sites, and deploying technology so patients can participate remotely to lengthen the time between site visits. Patients can use everyday technology to record themselves taking their medication and go into the clinic every three months, rather than having to travel every month to get their blood levels checked to confirm they are adhering to their treatment. This convenience means their participation can be largely unobtrusive to their daily life and makes the study more accessible.  

Equally important to recruiting diverse patients is retaining them. Once enrolled, a convenient and accessible tool like a smartphone can act as a patient companion that offers always-on lines of communication to the site clinician, interactive assistance to make sure they’re taking medication correctly, and proactive interventions when they seem to be having trouble staying on track with their treatment. By ensuring patients have the support they need, sites enrich their relationship with patients, helping to keep them engaged and contributing to the research.  

Taking a Patient-Centered Approach to Research Diversity  

There’s a lot of work to be done to make healthcare—an industry historically riddled with disparities—more equitable. Change is on the horizon. More and more clinicians are prioritizing working with pharmaceutical companies with equitable, diverse trials, setting the bar higher. Awareness of the problem from regulatory bodies, coupled with foundational leg work and a patient-centered approach, can help advance equality in healthcare. 

Sondra Pepe, Senior Vice President, Product Management, AiCure, leads the product management and testing teams. Sondra is responsible for the product direction, definition and delivery of the company’s award-winning artificial intelligence platform. With nearly 20 years of experience in eClinical SaaS technology across a variety of companies and products, including leading roles in product management at Medidata, Veeva, Medrio and ArisGlobal, Sondra delights in serving patients and participants, improving their experience and ultimately their health. Sondra started her career in healthcare provider offices where she specialized in insurance billing to help patients access the care they needed. She can be reached at Sondra.pepe@aicure.com.