Implementing Decentralized Clinical Trials: Strategic Design Vs. “Retrofitting”

The risks and challenges of retrofitting decentralized capabilities.

Decentralized Clinical Trials (DCT) came to the fore out of necessity during the COVID 19 epidemic to provide continuity to existing clinical trials. This pivot required ‘retrofitting’ to ensure participants could access care via remote or virtual services. Reducing trial participant burden whilst simultaneously maintaining trial delivery during a global health crisis can be seen as a great success. Now that we’ve emerged from the pandemic, the risks and challenges of retrofitting decentralized capabilities are apparent. Incorporating decentralized capabilities in the design of the trial is optimal for effectiveness and efficiency.

When We Retrofit

Retrofitting results in unplanned, and sometimes significant, efforts by sponsors and sites to amend protocols and contracts, redesign and deliver new protocol-specific training, as well as consider and address resource and budget implications. As a result, the adoption of DCT capabilities has been slower than expected. To drive improved participant engagement and trial performance the industry must strategically implement decentralized trials more proactively and efficiently, with early engagement of service providers.

Sponsors should focus on designing the most practical and participant-friendly studies, incorporating decentralized capabilities as early as possible in clinical trial design, as opposed to retrofitting DCT capabilities into near-finalized trial protocols or into ongoing studies. Moving to a new model in which DCT elements are considered and designed from the start, sponsors should be prepared to define a robust strategy and operating model, clearly articulating the opportunities for participants, physicians, and sponsors to generate buy-in and encourage change in a slow-to-change industry. This can be achieved by understanding the needs of targeted participant populations at the onset and assessing the decentralized capabilities to be incorporated into the initial trial design in parallel with development of the Clinical Development Plan. As a result, DCT capabilities can be integrated seamlessly during protocol development and set-up activities with minimal disruptions during study execution, which will ultimately drive more effective and efficient trials. By strategically designing an operating model that brings decentralized trials early into clinical design, sponsors can avoid the risks associated with retrofitting DCT capabilities.

An effective decentralized operating model should be designed considering the following:

• Optimization and/or redesign of early development processes to develop early, baseline thinking on DCT capabilities that will best support a trial and its participants
• Early engagement with third-party service providers (e.g., home healthcare) and technology providers to inform study design
• Involvement of in-country experts and regulators to evaluate variabilities in laws, regulations, and operational feasibility 
• Assessment of whether traditional roles and responsibilities need to adapt and evolve, for example to support remote participant engagement and monitoring
• Change management across sponsor, site and participants and recognition of the extra burden that may be placed on study teams when shifting to this new way of working and coping with the steep learning curve this entails
• Appropriately allocated resourcing and funding models to enable the above activities and ensure neither study team burnout nor study budget are barriers to the adoption of DCT capabilities

More Widely Implementing Decentralized Solutions

Decentralized clinical trials are a significant shift from the traditional way of conducting a trial and cannot be executed effectively if the industry considers DCT services to be "add-ons" or an afterthought. If decentralized clinical trials are to become more widely implemented and accepted, decentralized elements should be designed into trials from the very beginning and considered during planning activities. The complexities of reality will, of course, make this challenging and as a result, pharmaceutical companies will need to continue to grapple with the need to "retrofit" DCT elements into their trials.

What is certain, however, is that the industry will need to recognize that innovation requires a certain level of sacrifice, and therefore more investment is needed up front to develop improved ways to implement and see the benefits of a DCT model.

Contributors

Robert Liebman, Managing Director, R&D, Consulting, Syneos Health
Nathalia Negri, Engagement Manager, Syneos Health
Jessie Tucker, Senior Consultant, Syneos Health
Michael Serratore, Senior Consultant, Syneos Health
Hailey Durham, Associate Consultant, Syneos Health
Samina Nazmun, Associate Consultant, Syneos Health
Caroline Waksmunski, Associate Consultant, Syneos Health
Lucia Canedo, Analyst, Syneos Health

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