P205: Models for Agile/Decentralized Clinical Trials and Value Drivers Compared to At-Site Studies
Chief Product Officer
Advarra United States
To describe common delivery models for Agile / decentralized trials and drivers of value when compared to the traditional at-site model.
Models and value drivers summarized in this poster are a generalization of our company’s experience with delivery of over 125+ agile/decentralized trials.
While the concept of agile/decentralized trials existed prior to the COVID pandemic, the rate of adoption has increased substantially in the past two years and is predicted to continue to grow. This shift has been enabled by both the availability of technology (e.g., eConsent, eCOA, telemedicine) as well as the development and refinement of processes for collection of high-fidelity endpoint data outside of a clinical traditional site.
Through our experience in the delivery of over 125+ agile/decentralized clinical trials, we have seen the emergence of the following general models:
Virtual Site (Metasite): central investigator site (usually one per country), used stand alone or in combination with other decentralized elements
Virtual Site (Metasite) + Mobile Nursing/Other Home Care: metasite + home visits for hands-on patient care (e.g., blood draw)
Virtual Site (Metasite) + Community Providers: metasite + visits to community facilities (e.g., diagnostic imaging)
Virtual Site (Metasite) + Patient’s Own Investigator: Bring your own investigator (BYOI) model where patient’s own physician supports hands-on trial activities as a Sub-Investigator to the metasite
Traditional Site + Mobile Nursing/Other Home Care: blend of at site and home care activities to decrease patient burden of participation in the trial
Traditional Site + Remote Patient Follow-up: observational, long-term follow up remotely, via a combination of self-reported data, telemedicine investigators, mobile nursing/other home care, community providers, and/or real world evidence (RWE) such as EMR/EHR
Value drivers associated with use of these agile/decentralized models include: increased velocity of participant enrollment, greater participant diversity, enhanced participant retention, greater participant compliance in participant data collection, and decreased need for rescue sites. A more comprehensive benefit/cost model is currently in development for each of these models.
Agile / decentralized trials are rapidly becoming a standard part of clinical trial delivery. Discussions with both pharmaceutical companies and clinical research organizations suggest that increasingly, protocols are being written to offer the option of clinical trial designs in addition to the traditional at-site model, so as to avoid a protocol change for implementation.
While this trend towards agile / decentralized options was expedited with the pandemic, value drivers such as recruitment velocity/diversity, cost efficiencies, and increased patient compliance/retention suggest that the industry is unlikely to turn back to delivery solely through traditional brick and mortar sites.
As described in this poster, standard delivery models for agile / decentralized trials have emerged, however, the combination of models suitable for any individual trial will differ depending on the therapeutic area and protocol. Our experience suggests that certain areas have benefited greatly from these agile / decentralized designs, but for different reasons. For example, large simple trials, studies without need for at-site diagnostics in every visit, safety extensions, and observational studies, have all demonstrated significant cost efficiencies through agile / decentralized patient management. For studies in rare disease populations, the value driver has been the significant increase in enrollment velocity by bringing the clinical trial to any patient, any time, anywhere. Although the individual study value driver may differ, the greater benefit remains the same: provide greater access to clinical trials and speeding the delivery of new therapies to market.