by Sam Brown, Nell Haslett-Brousse, John Theodore

Originally featured in Clinical Leader

Today’s new COVID realities mean changes in how clinical trials are administered. Here’s what to consider in adopting decentralized clinical trials. 

As the COVID-19 pandemic turned the world upside down, clinical trials have been deeply impacted, with thousands of trials either canceled or delayed – all during a time in which speed-to-market is critical in helping deliver a vaccine to the global population.  

To continue trials with as little disruption as possible, the industry is accelerating adoption of decentralized clinical trials (DCTs). While speed-to-market was already the primary challenge for pharmaceutical companies developing therapies, industry stakeholders were already exploring the idea of DCTs to improve the R&D lifecycle, and the pandemic acted as a tipping point to move full steam ahead with this initiative.  The interruption of so many traditional trials heightened the importance of DCTs in the life sciences industry, with disease advocacy groups, regulators, providers, and patients actively looking for ways to re-start existing trials or design future trials that could be managed remotely. DCTs hold great promise to operate more efficiently, increase enrollment, shorten trial duration, get products to market quicker, and reduce patient burden by limiting travel, streamlining communications, and facilitating digital data collection. 

DCTs are not a new concept, but the ability to manage them more effectively with technology is a more recent phenomenon. DCT software platforms enable sponsors to conduct trials with a cohesive set of digital tools and services, reduce patient and site burden and lessen geographical barriers, all while still providing sponsors with quality data. DCTs are part of a flexible continuum where it is possible to start with a minimum investment (e.g. eConsent only) and build to a full-fledged virtual trial where all components of a DCT technology platform are utilized (e.g. eConsent, ePRO/eCOA, Telehealth, and wearables) to gain maximum efficiencies.  The new trial design creates an innovative solution to fit the study population and, ultimately, produce effective outcomes. 

As you consider implementing DCTs as part of your clinical trials, the following are some key considerations. 

Consider the Human Side 

Be sure to first focus on the human aspect of clinical trials: the patient journey, the challenges of doctors and sites, and the sponsor stakeholders trying to implement change. 

Start with the users at the center of change and understand both the burdens and benefits the use of digital technologies will bring. These technologies should enhance the patient’s journey, not complicate it. Moreover, technology should expand the investigator site’s ability to engage and treat patients and provide study teams new pathways to conduct their protocols. Understanding these users’ needs and pain points is paramount to driving adoption and creating champions of the technologies.   

Incentivize Use of Digital Technologies in Clinical Trials 

Without concrete evidence supporting the time and cost benefits or a re-alignment of incentives, study teams may view the shift to DCTs as more of a burden than a benefit. Moreover, the adoption and implementation structures should allow for some initial friction, growing pains, or “investment” that doesn’t count against study teams’ budgets. 

If a critical mass of study teams doesn’t buy-in and use the technologies, the sponsor will be unable to achieve economies of scale or measure benefits to prove that cost, time and compliance competencies are indeed gained.  

Validate Technology Vendor Promises  

Study teams may not care about all the capabilities a platform brings if the price is too high for their budget. With the novelty of these technologies, we currently rely on taking the vendor’s word about what they can deliver. When possible, validate these promises by playing around in test environments, looking at training materials, and understanding what case studies or best practices can be shared to ensure the right DCT model is deployed. 

Design Trial Protocols as “Virtual-First” With the Patient at the Center 

Approach study startup with a decentralized trial mindset and a willingness to challenge traditional assumptions. Collaborate closely with platform suppliers to design a protocol that works seamlessly with the platform to reduce operational friction and ease patient burden. Engage with patient advocacy groups to truly understand the patient perspective so the right flexibility can be built in to accommodate different patient types. 

The Bottom Line 

Ten years from now, if we’ve been successful in shifting the industry’s status quo operating model more towards DCTs, we’ll be able to prove the benefits with supporting data. However, the only way to ensure these data are meaningful and DCTs achieve the promised outcomes is by putting the human at the center of these trials, understanding and aligning their incentives, and subsequently deploying these technologies in enough trials to drive adoption, by truly understanding the right study design and fit to patient population.