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.