The clinical research industry is in a phase of notable change and rapid evolution. Decentralized trials, a highly useful format before COVID-19’s arrival, are now a necessary tool thanks to the unprecedented challenges created by the pandemic.
The Decentralized Trials and Research Alliance (DTRA) is a group bringing together stakeholders from the various corners of the field to help accelerate the adoption and understanding of the decentralized format. Craig Lipset, co-chair of the DTRA, spoke with Outsourcing-Pharma about the organization’s work, and what lies ahead.
OSP: Could you please tell us what the biggest challenge has been facing professionals in your corner of the life-sciences industry?
CL: Among the greatest challenges facing professionals in life sciences clinical research has been managing change. With responsibility for participant safety along with urgency for ensuring high-quality data in clinical trials, many in life sciences have erred on the side of caution when it comes to progress and innovation.
The pace of evolution of adoption of technology is creating an inflection point where the lack of adoption may create even greater risk. New technologies today can bring the opportunity to improve safety monitoring and enable more reliable sourcing of study data. Creating a culture of adoption and thoughtful risk-taking is vital for our collective future, and among our greatest challenges. As a shared challenge, some solutions will lend themselves well for collaboration.
OSP: Decentralized trials have continued to gain ground, with COVID-19 creating both obstacles and opportunities. Could you please share your thoughts on how sites and sponsors have risen to the challenge?
CL: As the COVID-19 pandemic created lockdowns limiting participants’ willingness or ability to travel to sites along with operating constraints for many sites themselves, the collective research community embraced an unprecedented shift toward decentralized research methods. The shift was a critical countermeasure to the operating risk in our environment and was rapidly supported by regulators, sponsors, sites, and research participants.
Regulatory authorities around the world acted with urgency to create guidance documents for research sponsors making clear the acceptable use of decentralized approaches, and sponsors adapted studies with protocol amendments and deviations allowing visits to take place away from sites leveraging video, home health, and remote monitoring. Research sites rose to this challenge, with WCG CenterWatch reporting site use of telemedicine increasing from 28% prior to the pandemic up to 64% by the summer of 2020.
Meanwhile, participants and caregivers rose to the challenge, as CISCRP reported that 90% of study participants in mid-2020 had experienced a change in their participation led by the shift to telemedicine and the use of virtual visits. The next challenge for the community has been to commit to these changes within organizations, helping teams to ensure appropriate decentralized research methods remain available globally for research participants.
OSP: It has been an interesting inaugural year for DTRA—could you please share an overview of your goals, what you’ve accomplished, and what might lie ahead for your group?