Jiang Li, Ph.D., is the founder and CEO of Vivalink, Inc.
Politicians love the adage “Never let a good crisis go to waste” – a rallying cry for finding a silver lining in turbulent times. In a post-pandemic world, healthcare may be missing out on this very opportunity, failing to realize the full potential of decentralized clinical trials (DCTs). DCTs provided a lifeline for disease treatment and drug development when many clinical settings were so riddled with Covid-19 that it was unsafe to continue in-person activities.
Learn more about DCTs
DCTs — studies of treatments or medications conducted with participants who are not in a single location and may never set foot in a hospital — have been used for many years, but the pandemic has made them an important part of ongoing care and drug development . Providing access to clinical trial participation for a more diverse population has already been a goal of many medical clinicians, but the pandemic has highlighted both the need and possibility for trials of this format.
Circumstances made DCTs a necessity, but an examination of their effectiveness during the pandemic laid the groundwork for refinements and improvements – if used to their full potential. To move forward and get the most out of DCT techniques requires investment in technology, data quality and potential applications. Lessons learned from the pandemic and earlier should be put into practice to develop more refined, more effective studies in the future. Pursuing these goals could reduce the burden on participants and give researchers more insight into potential clinical applications.
When should a DCT be used?
As with traditional clinical trials, DCTs vary widely and are not appropriate solutions for every scenario. When it makes clinical, logistical, and financial sense, a DCT can provide real-world data that reflects how a patient is affected beyond a specific clinical endpoint. This discussion focuses on drug development studies and the post-pandemic potential for even more effective evaluation of new drugs.
Because fully decentralized trials are not feasible for every case, it may be worth finding situations where the benefits include greater patient diversity, convenience, and compliance. Some researchers point to the potential benefits of new study designs, such that by reviewing study endpoints for safety and efficacy, it may be easier to look for functional outcomes rather than just objective academic outcomes. In other words, study design can take into account how patients are doing in the home rather than clinical setting, and each participant can be individually assessed and tracked as to how their results impact a study endpoint.
DCTs facilitate a convenient, patient-centric set of endpoints to provide a longitudinal cross-sectional view of the patient’s condition. Instead of regular glimpses, we are able to see a complete picture through the continuous transmission of data from the remote monitoring technology used to pull a study out of a hospital setting. For example, rather than receiving sporadic data points on Arthritis Patient A during visits to a clinical study site, it is possible to know that he is walking up and down stairs more frequently after starting a test drug, and examine his progress over time.
A close examination of the remote monitoring data can provide a more accurate analysis of the patient’s condition. For example, a study can compare the patient to their own data points. Researchers’ access to continuous data may allow them to more easily follow individual and study-wide trends.
This approach represents a sea change for an industry that has traditionally relied on conventional clinical research and trials—methods dating back in some cases to the 1940s. Although the rationale for a study can vary widely depending on the intent and stage of development, there are reasons to support the decentralization of the process.
Shifting the paradigm
Expanding thinking about what Remote Patient Monitoring (RPM) and DCTs can achieve in terms of ambulatory data collection requires innovations in interpretation and collaboration that could better serve both participants and industry. The entire industry needs to embrace the idea of the paradigm shift – if only for some studies – from clinical experience to real world experience and from a hard and fast objective biomarker to a more functional biomarker.
Addressing the cost is obviously a consideration. Research shows that in traditional clinical trials, patient recruitment and retention are two key issues that can delay development. These delays, in turn, increase overall costs. The number of patients needed to establish treatment effects is another important influence on the estimated cost, followed by the number of clinic visits required for screening, treatment, and evaluation.
Given this cost, we can conclude that DCTs are inherently less expensive and certainly less expensive. While the decentralized option is not an all-or-nothing approach, combining some traditional elements with some decentralized aspects offers an opportunity to get high-quality, continuous data. This then provides the necessary information to change our approach to some studies to a more workable model.
What is the next step? As an industry, we must use the best infrastructure to achieve our ultimate goal, including making fit for purpose remote sensors and strategically aligning their locations. We must be careful how we collect, analyze, handle and present data. By expanding thinking about what RPMs and DCTs can do in ambulatory data collection and innovating in interpretation and collaboration, we can better serve both study participants and industry.
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