Written by Amy Neuer, Applied Clinical Trials
Clinical trial stakeholders weigh in on the major shifts unfolding in the era of COVID-19, as efforts move away from the traditional site-based model.
In 2000, Malcolm Gladwell’s The Tipping Point became a runaway bestseller by describing the factors that fuel an epidemic, and how the world suddenly becomes a different place as it reaches the inflection point. He discusses epidemics as spreading quickly like a virus, causing people to start behaving differently, triggering contagiousness, whether it applies to fashion trends, the uptake of cell phones, or the spread of disease. Gladwell’s explanation of how epidemics occur bears an uncanny resemblance to what is happening in the clinical trials sector as stakeholders are abruptly changing entrenched study behaviors due to the impact of the COVID-19 pandemic, raising questions as to whether these changes will persist once it subsides.
This article takes a look at an industry in flux, with the pandemic driving a long-awaited trend away from the traditional site-based study model toward one that is more patient-centric, meaning that decentralized and hybrid approaches may finally be taking hold. These newer methods, which include home study visits, telemedicine, and remote monitoring, have been happening over the past few years, but uptake has been slow, reflecting the clinical trials industry’s renowned conservative view of change, often citing regulatory concerns, and clinging to an “if it ain’t broke, don’t fix it” attitude. This resistance has stubbornly persisted despite sobering statistics. A recent study from the Tufts Center for the Study of Drug Development (CSDD) found no significant differences in the mean number of patients enrolled per site or by therapeutic area in 2019 versus 2012.1 The study also showed that late development studies had a higher average drop-out rate in 2019 (19.1%) than in 2012 (15.3%).
This may all be about to change, and fast, due to the COVID-19 pandemic. Suddenly, with participants unable to get to the site, or unwilling to travel for fear of contracting the virus, sponsors and contract research organizations (CROs) are anxious to embrace patient-friendly decentralized practices in a big way, hoping to curb the number of studies that are shutting down or not starting at all. Darcy Forman, vice president of clinical operations for Science 37, a provider of virtual clinical trials, comments, “We have been unbelievably busy with this pandemic as sponsors are wanting to transition to a virtual model. It’s really accelerating, and they are finally pushing through their hesitancy.”
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