Achieving Diversity and DEPICT Act Compliance in Clinical Trials

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 Wipro's 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: 

• Digitalized clinical trial recruitment
  Many clinical trials continue to recruit partly via physical flyers posted near hospitals and universities that host the trials. These hyper-localized practices introduce an understandable but increasingly avoidable demographic bias into clinical trial populations. Digitizing clinical trial entry points is the first step toward broadening the clinical trial funnel. As demonstrated in the prototype above, connected digital experiences focused on education and awareness in diverse communities around the country will engage previously unreachable trial candidates and their families/caregivers, broadening the clinical trial pipeline. New cloud-native digital experiences should also be extended to physicians. In the case of oncology, around 80% of clinical trial participants find out about the clinical trial either through their provider or directly from the study team. By reaching more physicians in more communities with information about clinical trials, trial sponsors will inevitably reach a wider array of patients.
• Fit-to-purpose hybrid trial design and engagement
  For most conditions, fully virtual drug and medical device trials will never be practical. However, the same connected approaches that will supercharge patient recruitment will also be applicable to running hybrid clinical trials that will be more convenient and less time-intensive for patients. In cases where both the patient population and the trial design seem to fit with a hybrid approach, trial sponsors will have the opportunity to truly dissect and reassemble the trial design with a digital-first mindset, reducing the need for travel and creating patient portals that are much more engaging than current telemedicine-based approaches. Continued advances in wearables, medical devices and digital biomarkers will further enable remote data collection for clinical trials, requiring frequent adjustments to clinical trial protocols as new technologies are onboarded.
• Clinical trial retention
  While diversity shortfalls are often traced to suboptimal patient acquisition practices, trial sponsors also need to consider patient retention, and create tools that enable all trial participants to effortlessly adhere to trial protocols. Drop-out rates in clinical trials can exceed 30%. In trials where there is a significant demographic disparity in that dropout rate, the overall balance of the trial will be impacted. Both hybrid and fully in-person clinical trials can now leverage connectivity tools like a collaborative care platform (see Figure 2) to better manage variables like medication adherence, ensuring that more patients complete the trial. Because this collaborative care platform would also be connected to HCPs, it would also empower patients with tools like personalized health notifications, medication cost comparisons, targeted condition-specific education, scheduling reminders, caregiver tools, and connections to advocacy communities. As patients engage with the platform to improve their health beyond clinical trials, it would feed valuable de-identified data back to the life sciences company, creating a personalized patient-HCP-life sciences loop.

• Digital twins in clinical trials 
  Since the dawn of formal clinical trials, one of the lingering ethical discomforts has involved the necessity of control groups that receive the placebo rather than the potentially life-altering therapy itself. Without a placebo group, it has simply been impossible to demonstrate proof of benefit. Yet clinical trial patients do worry about being placed in the placebo group, and the very existence of placebo groups likely disincentivizes clinical trial participation, particularly for less acute medical conditions. Digital twins can now leverage virtual and augmented reality in a metaverse environment to model how a therapy will likely impact a given patient’s biological state. Digital twins may soon reduce the reliance on placebo groups, particularly in the early stages of drug development, making clinical trials more efficient and effective for patients and reducing the percentage of patients who drop out of a clinical trial or are unable to follow lengthy trial protocols. Patient-oriented messaging about digital twins should emphasize that digital twin technology is designed to accommodate a fully diverse community of patients (including presenting examples of digital twins of diverse individuals), while also making their clinical trial experience less time-intensive. (It is worth noting that digital twins can also be used to run synthetic clinical trial scenarios and protocols to further streamline clinical trial design and reduce complexities and compliance challenges.)
• Industry collaboration
  Few clinical trial sponsors can afford ambitious engagement campaigns, and clinicaltrials.gov remains challenging for patients to navigate. In the future, an industry-wide pharmaceutical consortium may opt to create a centralized, immersive hub for clinical trials that allows patients around the world to seamlessly access information about the clinical trial landscape. Patients and providers both lack an intuitive system for identifying and comparing clinical trials, and such a platform would be a game-changer when it comes to matching diverse patients around the globe with the ideal clinical trials. 

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.