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Many biopharma are seeking ways to make their studies more resilient and minimize future disruptions, like they experienced with COVID-19, according to E.B. McLindon, Senior Vice President, Patient, Site & Decentralized Solutions, ICON plc. “Decentralized innovations will continue to support the evolution of the overall clinical trial process, and further enhance the patient and site experience,” he believes.

ICON plc is a service provider at the marcus evans Evolution Summit 2020 and the Evolution Summit 2021.

What methods of decentralizing trials have been accelerated by the pandemic?

At the onset of the pandemic there were two key areas of focus – patient safety and access to clinical research data at the site level. In many cases, this had to be accomplished by converting traditional study conduct (i.e. monitoring source documents at the site) to a more decentralized approach with the support of the regulatory authorities. 

Many biopharma immediately engaged mobile research nurses to conduct in-home patients to follow up or wellness checks to support patient safety. Many of these visits were amended to allow for the nurse to deliver investigational products to the patient’s home. Another solution to assist with patient safety that was less widely utilized, but deployed nonetheless, was telemedicine. In some cases, this solution was coupled with mobile research nursing.

During the initial outbreak of the pandemic, many sites were open but were not permitting on-site data monitoring to occur, in other words – oversight and management of study conduct was very limited. In response, the industry implemented many remote monitoring tools and processes to support the gathering and evaluation of valuable research data. As we look to the future, we anticipate more utilization of remote monitoring with remote SDV. 

The industry awaits to see if these solutions, among others, are fully adopted to aide in reducing the site and patient burden on future studies regardless of emergency.

How have sponsors attitudes to decentralized trials changed as a result of the pandemic? 

Many biopharma are seeking ways to make their studies more resilient and minimize future disruptions as have been experienced this year. To that end, we see strong movement from a traditional site-based approach to a more hybrid trial approach – incorporating aspects of decentralized solutions (technology, process, techniques) rather than an adjusted attitude to go fully decentralized (where no physical on-site patient visits occur – all visits are conducted remotely via telemedicine or in the patient’s home).

The key factors that drive adoption are protocol-based and reside in the therapeutic endpoint, overall study design, investigational product safety profile, patient profile, and country/regional regulatory acceptance of decentralized technologies and processes. 

How has the outlook for the future of decentralized trials changed as a result of the pandemic?  

In addition to biopharma’s interest in making trials more resilient in challenging times, the industry is recognizing the importance of reducing patient burden by providing study participants with options. Prior to the pandemic, we witnessed how home-based patient visits increased patient satisfaction, compliance, and retention. We firmly believe that by offering patients options to participate in research, we increase the patient catchment area to provide more access to research for a diverse population. In short, we need to make a patient’s participation in research no different or less different than their standard of care journey – we need to be able to present clinical research as a care option that mirrors their current care options. To this end, the patient outlook is shifting as well. 

Decentralized innovations will continue to support the evolution of the overall clinical trial process, and further enhance the patient and site experience. We firmly believe that many of these solutions are here to stay and will be deployed appropriately to meet the overall goals of the individual biopharma and their protocol.