Decentralized Clinical Trials—Where the Industry is Now.

The widespread adoption of telemedicine ushered in by the pandemic, fueled a shift to a more flexible and patient-centric process for clinical research conduct. The shift from the traditional way of managing clinical research to a decentralized approach expands patient access for rapid and diverse recruitment. It also enables the collection of high-quality data—a product of unified processes and centralized coordination across telemedicine investigators, mobile healthcare professionals, and local providers.

From cancer diagnostic trials that incorporate biospecimen collection, imaging, and gold-standard screening modalities; to respiratory trials leveraging healthcare professionals trained to support spirometry; to CNS trials that require advanced neurological assessments in a patient’s home—the agile clinical trial approach supports patient choice in study delivery— whether it is in the comfort of their homes or at a site/local clinic when preferred or necessary.  For studies in rare disease populations, the value is seen in the breadth of access to patients, enabling enrollment regardless of their proximity to a traditional trial site. 

In the context of clinical research, agility means the ability to work multiple models of delivery for the same study, including fully decentralized, at a traditional site, and hybrid models, all within the same study.  Use of technology to coordinate the delivery of a clinical trial across stakeholders and settings is critical to successful study delivery.  Study sponsors wanting to simplify and streamline the user experience will go a step further to deploy a unified platform to both engage users and orchestrate endpoint collection across the myriad technologies needed to deliver the study schedule of assessments.  Through our experience in operating these agile trials, we would also add that building flexibility into the protocol design upfront can greatly expedite time to start-up should the hybrid or DCT method be offered as a risk mitigation strategy for slower than desired enrollment.

Agile trials have rapidly become a prominent tactic for optimized clinical trial delivery. One recent survey of trial sponsor executives found that 77% of respondents plan to conduct an agile trial within the next 12 months. (1). In addition to these metrics, discussions with both pharmaceutical companies and clinical research organizations suggest that increasingly, protocols are being developed to offer the option of decentralized or hybrid clinical trial designs, in addition to the traditional at-site model.  

Common Models of Hybrid Clinical Trials

As decentralized clinical trials continue to grow and mature, pharmaceutical and biotech leaders continue to find new ways to implement this mix of virtual and hybrid trials to deliver a truly patient-centric model. A series of models, as described below in order of decreasing decentralization, have become common in the clinical trial space, but many more exist and as new needs arise, models will adapt or develop to further evolve the agile trial.

A Virtual Site (Fully Decentralized Site) 

In this model, sponsors supplement their traditional site network with a virtual site to accelerate patient enrollment without the need for starting up additional sites. A virtual site leverages technology, telemedicine investigators, and home-based care to allow  study activities to happen at home, eliminating the friction of geography. Telehealth functions take place in the patient’s home, expanding access to potential participants that are either located too far from a traditional site or are unable to travel due to illness, work responsibilities, parental/dependent care, lack of access to transportation, or financial constraints.

Virtual Site Plus At-Home Support for Traditional Site Participants (Hybrid)

In this approach, traditional and virtual sites work on the same trial with assistance from home resources such as mobile nursing.  This model is transformative as it streamlines recruiting, onboarding, and patient monitoring, while maintaining process compliance across all trial delivery settings, enhancing data collection, speed, and quality to deliver a seamless trial experience. Researchers often opt for this model when conducting trials where sponsors need a patient-centric approach to study delivery to achieve enrollment targets with the greatest velocity while continuing to foster traditional site relationships (e.g., KOLs).

Site-Initiated With Remote Management

This model combines the traditional brick-and-mortar delivery model with home-based healthcare to allow patients to conduct a portion of their visits remotely, decreasing the burden associated with time spent on travel and at site.  This is particularly important for patients who can’t tolerate long at-site visits due to fatigue, nausea, and other side effects. Remote visits are typically conducted through visiting nurse services and telehealth tools. This flexible model is used across numerous therapeutic areas where it is advantageous to identify the patient population via a traditional site and/or only a portion of protocol visits require a site visit for procedures that are not easily delivered in the home.  

The Benefits to Hybrid and Decentralized Clinical Trials 

Agile clinical trials are rapidly becoming a standard part of clinical trial delivery. Discussions with pharmaceutical companies and clinical research organizations suggest that increasingly, protocols are being written to offer the option of hybrid and decentralized clinical trial designs to avoid the time and cost of a protocol amendment in cases where DCT conduct was not incorporated at the time of study initiation.

Science 37 has built a customizable model to quantify the hidden costs associated with the traditional delivery model and benefits associated with hybrid and decentralized designs.  Through the model, sponsors can see and quantify value drivers such as enhanced recruitment velocity and diversity, cost efficiencies, reduced human error, increased patient compliance, and higher retention rates. These significant and measurable improvements suggest that the industry is unlikely to return to delivery solely through traditional brick and mortar sites. 

To learn more about decentralized and hybrid clinical trial models and how to implement agile trials to enhance research, download Science 37’s Clinical Trial Playbook.

Source:

1. Zucker, Irving, and Brian J. Prendergast. "Sex differences in pharmacokinetics predict adverse drug reactions in women." Biology of sex differences 11.1 (2020): 1-14.