Introduction: Diversity Challenges in Clinical Trials
According to one estimate, 50% of US clinical trial participants come from 1-2% of all ZIP codes. Members of Black, Latino and Asian communities are massively underrepresented in clinical trials. Furthermore, patients from all communities are impacted by an awareness gap when it comes to clinical trials. According to the latest National Cancer Institute Health Information National Trends survey, only 11.3% of respondents indicated that they knew “a lot” about clinical trials. This awareness and access gap comes with consequences. Without a sufficiently diverse pool of trial participants, there is a perennial risk that new drugs and therapies might underperform for underrepresented populations.
In an effort to address these continuing disparities in drug and device trials, the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act—which the US Congress folded into the January 2023 omnibus spending bill—mandates a diversity plan from clinical trial sponsors. Furthermore, when sponsors fail to meet diversity enrollment targets, the FDA will have the authority to mandate post-market studies that would impose additional work and costs on trial sponsors. In the coming year, companies that sponsor drug or device trials will be seeking new practices and technologies to improve the diversity metrics of their clinical trials.
Connected Clinical Trials: Bridging Distances to Reach Diverse Populations
Digital healthcare technologies, strategies and solutions are impacting patients across the healthcare landscape, and the impact of digital and cloud-based approaches is being felt in clinical trials as well.
Historically, an implicit but powerful predictor of clinical trial participation has been simply proximity to clinical research facilities. Recently, the advent of wearables and digital biomarkers has enabled researchers to look further afield for trial participants. New connected, digital-first approaches to clinical trials will allow trial sponsors to complement this growing wealth of digital patient data with a mechanism to meet distant patients face to face.
Connectivity tools and strategies enabled by the metaverse and the cloud are poised to revolutionize clinical trials. By making clinical trials more accessible to physically dispersed candidates and more engaging for trial participants, a truly connected clinical trial ecosystem will provide the building blocks for more diverse and equitable clinical trials.
Clinical Trial Recruitment Pods: A Connected Care Prototype
To visualize how a connected clinical trial ecosystem could solve both awareness and access challenges, imagine how interactive VR-enabled pods might connect pharmacy visitors around the country with experiential yet data-rich exposure to relevant clinical trials.
Figure 1: A Diversity-Enabling Prototype for Clinical Trial Recruitment and Education
Stationed near drug store pharmacy counters in diverse communities across the country, interactive HoloLens-equipped pods could allow drug and device companies to connect with a vast array of individuals, many of whom would have no other mechanism for encountering or learning about these trials. In some cases, thanks to regular foot traffic, the pods would attract individuals who have only tenuous contact with the healthcare system—an important factor given that many patients find out about clinical trials through doctors and healthcare providers. (In our recent multi-industry metaverse study, most respondents expressed concern about potential disparities in access to metaverse technology and hardware; providing public access to metaverse hardware could be a powerful tactic to combat those disparities.) Pharmacists would be able to refer patients to the pods based on their prescriptions, and educational materials available on or near the pods would describe the clinical trial experience and its benefits.
For many individuals, clinical trials can seem intimidating and highly technical, and the companies that run them appear to be faceless entities. The immersive intimacy of a VR experience would provide a more human entry point to the clinical trial funnel. The VR experience would transport the patient to the lobby of the trial site, and walk them to the clinical trial check-in desk, where they would be greeted by a virtual receptionist or clinical research coordinator and provided with clinical trial education and information about clinical trial matching. A virtual exam might even facilitate trial matching in real time.
Such a solution would reach not only clinical trial candidates themselves, but also caregivers of potential clinical trial candidates. For patients who require high levels of caregiver support, including patients struggling with stigma around their condition, caregiver buy-in and support is essential. Providing caregivers with relevant information about clinical trials in a convenient location, and making them comfortable with the clinical trial process, is crucial when it comes to recruiting individuals who may not be able or inclined to independently enroll in a clinical trial.
Building a Connected Ecosystem to Support Diverse Clinical Trials
While few clinical trials themselves are likely to be 100% virtual, a connected care ecosystem will leverage a hybrid approach to clinical trials that will be more accessible to diverse populations of trial participants. Digital connectivity will increasingly play a role through the entire clinical trial funnel, from initial education and awareness through clinical trial execution. In particular, a connected clinical trial ecosystem will bring new approaches to:
Conclusion: Diversity Through Connection
To attract a diverse clinical trial population and achieve DEPICT Act compliance, trial sponsors will need to think outside the box and expand channels of outreach, taking into account the day-to-day experiences of prospective patients and creating opportunities to meet diverse patients in their own communities. Metaverse-enabled clinical trial pods demonstrate how the current clinical trial funnel could be substantially broadened by technology innovation, reaching diverse communities throughout the country.
More broadly, there is an opportunity to fundamentally reshape the clinical trial experience by leveraging the cloud to engage, educate and empower all communities of patients, encouraging them to stay the course and complete clinical trials. Hybrid trial design will reduce the need for travel and cumbersome protocols. A collaborative approach, particularly via a collaborative care platform that engages both HSAs and clinical trial sponsors, can turn the clinical trial process into an opportunity to empower patients with wearables, health apps, disease awareness tools, and other digital care devices that allow them to play a proactive role in their medical decision-making.
Digital healthcare solutions have raised the bar: Patients now expect a frictionless healthcare experience with more control and access to an integrated and holistic data flow that takes into account all stakeholders involved in their continuum of care. Clinical trial sponsors can achieve significant advantages by learning from and collaborating with this cloud-driven digital healthcare ecosystem while simultaneously introducing that collaborative ecosystem to a more diverse set of potential clinical trial patients.
Vice President and Global Leader, Life Sciences
Gaurica is a proven industry leader with more than 20 years of experience in management consulting and life sciences, primarily focusing on business and digital transformation, cloud development, health equity, and clinical and commercial strategy. Gaurica specializes in connecting with clients and partners to find innovative solutions to complex business problems.
Luke Sykora - Content Writer, iDEAS