“2021 will be the year of the global decentralized clinical trial,” declared John Reites, president technology and service provider THREAD, which specializes in enabling decentralized clinical research. “2021 is shaping up to be a transformative year for sponsors and CROs. Decentralized clinical trial (DCT) approaches, which have proven to be more sustainable in times of uncertainty, will take priority over traditional designs in 2021. Rather than adopting midway through the trial, as many did throughout the pandemic, studies will embrace DCT as their design of choice at the start of the planning process. As the industry aims to improve recruitment, retention, and data collection, there will be an increasingly heightened focus on trial flexibility and participant inclusivity. This focus will catalyze the industry’s inevitable shift to more global studies, powered by hybrid DCTs. 2021 will be a pivotal year for the expansion of global studies as the viability of traditional trials continues to dissipate.”
Reites was one of several executives who told us they expect a seismic shift in the conduct of clinical trials.
“2020 will be known as the year the biopharmaceutical industry (re)designed health care – and it will have enduring implications on the way we do business in 2021 and beyond,” said Rick Winningham, chair and CEO of Theravance Biopharma Inc., a member of the COVID R&D Alliance (which brings together more than 20 companies including most of the biggest global pharmaceutical companies). “Future innovations resulting from today’s vaccine and therapeutics, and also the application of digital solutions to advance non-coronavirus-related programs, will have impact across all stages of business from research and development to commercial products."
Winningham continued: “For example, we worked collaboratively with regulators to decentralize one of our clinical trials, balancing in-person and remote health care to improve safety for patients and health care professionals. This allowed participation from patients at home while ensuring data integrity in a clinical trial program we are conducting in a fragile patient population. This change was embraced by the community and will hopefully have a lasting imprint on how clinical trials are conducted far into the future.”
Peyton Howell is executive vice president and chief commercial and strategy officer of contract research organization Parexel. “Looking ahead to 2021, Parexel and other CROs will apply the lessons learned with a #NoGoingBack mentality,” she said. “We expect to see an increased adoption of decentralized clinical trials, also known as virtual clinical trials, a heightened focus on diversity and access to
clinical trials, along with a continued focus on the heart of everything we do – patients.”
Stuart Peltz, CEO of PTC Therapeutics, Inc., agreed. “The pandemic stimulated a plethora of new ideas on how to do clinical trials. These changes have specifically impacted clinical trials and patient care, as we all began working remotely. This included remote patient assessments, telehealth evaluations, and remote monitoring devices. This trend will continue, and despite the new virtual format, we have not jeopardized the quality of care for the patients. In fact, my view is this new format can actually accelerate trial enrollment in 2021 – particularly for patients living with rare diseases who are often geographically far from the appropriate study center(s) or can’t travel."
Peltz added: “With the evolution of virtual and remote trials, patients no longer need to be put at increased risk by traveling into hospitals or trial sites, and with telehealth we’ll be better suited to provide faster and more frequent therapy interventions – all of which can help evolve our standard model of care. So, while the pandemic has made us find new ways to work, we’ve actually uncovered many improvements. From challenges comes opportunities to evolve and become more efficient, and I believe 2021 will allow for continued changes to the way trials are conducted, for the better of patients and their families.”
For more predictive content, visit our Outlook 2021 pages: invivo.pharmaintelligence. informa.com/outlook