The COVID-19 pandemic interrupted clinical trials, the research programs that test medicines and treatments for diseases and other medical problems. Participants were following stay-home recommendations and medical centers were not prepared to handle a mix of patients infected with the coronavirus and other patients coming in for routine appointments and lab work.
While many trials have resumed, the unexpected obstacles gave new urgency to the idea of “decentralized clinical trials” – research programs structured in a way that requires far fewer in-person visits. Participants skip the hassle of traveling to a medical center and instead use wearables, apps and other technology to gather data while at home or at least closer to home. And researchers would gain a bigger pool of potential participants because more people would likely be willing to participate.
In a broad sign of support for decentralized trials, more than 50 biotech and life sciences companies – including CSL Behring – have joined the newly formed Decentralized Trials and Research Alliance. The alliance says its mission is to “make clinical trial participation widely accessible by advancing policies, research practices and new technologies.”
CSL Behring is excited to join DTRA because it provides an opportunity to work with colleagues across the industry, said CSL Behring Vice President of Clinical Development Operations Craig Coffman. Alliance members will share experiences and best practices to better design and execute clinical trials.
“Increasing participation in clinical trials benefits our industry immensely, bringing new treatments to those in need,” Coffman said. “It is heartening that through the combined efforts of pharma, technology and regulators we can have a profound effect on the patients we serve.”
Some of the other participants include Pfizer, AstraZeneca, Biogen and Bristol Myers Squibb. Craig Lipset, a pioneer in decentralized trials, is also part of the effort. Lipset, who was previously at Pfizer and a founding manager of several startups, designed and launched the first fully remote clinical trial.
"Now is the time to share ideas and insights that will chart the future course of clinical trials, accelerating drug development and saving lives," Lipset said in a release announcing the alliance. “We have a responsibility to advance the health of people with unmet medical needs, and by convening stakeholders we can remove remaining barriers to adopting new policies and practices that can impact patients today.”
A 2018 study in Switzerland compared a traditional and decentralized approach in a trial for people who had serious back pain. They found some delays and obstacles, such as having to ship wearable sensors to patients’ homes, but also noted the potential of a decentralized approach.
“This pilot study showed that designing clinical trials in a patient-centric manner using a decentralized study setting is operationally feasible and well-accepted by the patients,” according to the research published in Contemporary Clinical Trials Communications.
COVID-19, which derailed an estimated 900 clinical trials, forced organizations to use decentralized methods and inspire new approaches, said Amir Kalali, MD, life science executive, founder of several collaborative life science communities, and co-convenor of DTRA.
“The benefits of decentralized research methodologies have been apparent for some time, but adoption has been slow due to many factors including culture and the lack of a forum for stakeholders to collaborate,” Kalali said.
