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A top-down analysis of the decentralized trial model’s benefits and impact on the industry.
There is arguably not one industry that has not been touched by COVID-19 in some way, with clinical trials—and the professionals responsible for their success—faced with constantly changing operations and patient enrollment. When not managed correctly, these rapid changes can have an adverse effect on the timeline of a trial, which can be critical for those who may rely on the not-yet-released drug for life-saving care.
These conditions will continue to be uncertain for the foreseeable future, so sponsors have little option other than to take an agile approach. Likewise, the work of talented and skilled clinical research associates (CRAs) is perhaps more vital than ever, as they are on the front lines navigating how the evolving clinical landscape impacts them and patients alike—including how to safely travel to and from study sites.
This article will present a top-down analysis of the decentralized trial model’s benefits and impact on the industry, as well as its narrow impact on the CRAs responsible for monitoring clinical sites to ensure testing and data integrity.
The first step in successfully adjusting clinical trial operations during COVID-19, or any pandemic event, is to think differently across all aspects of trial operations, including site visits and data collection, among others. Most importantly, these considerations should place patient safety and centricity, as well as employee safety, among its top priorities.
Decentralized solutions1 arguably provide the most value in addressing the questions at the center of sponsors’ minds during this time. From improving patient experience to increasing patient retention and data quality, the different levels of decentralization offered allows for a personalized and streamlined solution based on the specific needs of trials and programs.
It is important to note that a Risk-based Quality Management (RBQM)2 foundation is required, as it focuses on identifying the critical data, processes, and potential risks unique to each trial. Once identified, sponsors can then determine the appropriate monitoring strategy, choosing virtual or hybrid model for their trial, as well as implementing strategic plans for remote and central monitoring, technology, integration, IP management, and site and patient engagement.
Patient centricity and study logistics are essential components of a clinical trial, neither of which could be operated successfully without the expertise and time offered by dedicated CRAs and other study staff. From project initiation through site selection and activation, clinical operations teams ensure first patient first visit (FPFV) goals are met by conducting a thorough feasibility process and onsite qualification visits. Likewise, they keep a close eye on recruitment and retention, data quality, protocol deviations, and more to make sure that database lock happens promptly following last patient last visit (LPLV).
When COVID-19 hit, the traditional clinical trial site was turned on its head, both for study staff and patients alike. Perhaps the most significant roadblock staff have faced thus far in the pandemic is the lack of resources available. Due to the confidential nature of clinical information and the need for procedures, these resources were not available for sites that had closed and transitioned to remote work. For these trials, the lack of resources would bring about slight delays in getting certain tasks completed, such as IP accountability which must be captured on site.
Whether sponsors choose a hybrid or virtual model, CRAs and other management staff take the brunt of following through on these operational changes, especially as they relate to clinical monitoring. In a quality-driven, risk-based approach, the schedule of visits relies on the judgement of the study team and access to the risk control measurements. This streamlined approach to the clinical trial monitoring process can reduce the burden of on-site visits for the sites, as well as the overall monitoring budget, while not sacrificing the quality of the data.
Likewise, each site will have its own set of procedures that must be followed. For example, a CRA may have to request an on-site visit two weeks in advance and can only proceed after receiving approval. On the other end of the spectrum, the clinical monitoring process may more heavily rely on remote/electronic approaches, such as the use of an electronic data capture system (EDC).
Regardless of which COVID-19-related procedures are implemented, study management staff must also make sure they document these changes by updating study plans and protocols throughout the trial or program (i.e., project management plan, clinical monitoring plan, etc.). This is crucial for ensuring compliance and generating reliable data to support study endpoints.
From sponsors to study staff and patients, every stakeholder in a clinical trial has been and will continue to be impacted by the operational changes brought about by COVID-19. It is important to note that the possibility of more on-site visits will likely be delayed as we continue to adapt and recover over time. However, even before the pandemic, the clinical research industry was constantly evolving and innovating to meet the needs of—so it is well-equipped to master the management of any roadblocks they may encounter now and into the future. Perhaps the greatest lesson we can learn from these changes is the importance of communication and cohesion among sponsors and study management staff to ensure success and confidence amidst pandemic-era operations.
Sharon Duffy is the Associate Director of Clinical Monitoring at Rho