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?
CL: DTRA was launched to ease the global adoption of appropriate research methods. Since our launch, the number of participating member organizations has swelled from 50 to over 130 representing research sponsors, regulators, service providers, technology companies, site networks, advocacy groups, and more from around the world. These organizations comprised the Leadership Council for DTRA and served as the launchpad for collaboration.
DTRA members worked quickly to establish our four Priority Areas for work together, including improving definitions, sharing best practices, expanding through education, and removing remaining barriers to adoption. Members then defined 12 initiatives supporting these priorities and launched 12 Initiative Teams with key leaders from across the community. In parallel, a Regulatory Forum was created to ensure consistency in our engagement with regulatory authorities around the world.
Today roughly 350 leaders in decentralized research are sharing their time across DTRA councils and initiatives, working together to achieve our shared goal of global access to decentralized methods.
In addition to our initiatives, DTRA has created a community of leaders to support and share experiences. This community came together at the first DTRA Annual Meeting in November, a hybrid in-person and online event. Together the community shared updates on initiatives, as well as the connections to other collaborations, insights from patients and investors, and capabilities emerging to support adoption.
OSP: Anything to add?
CL: As competing demands emerge for many research leaders and teams it is easy to become complacent about the work required to support global adoption of new approaches such as decentralized research. Now is a critical time to leverage the momentum in the community to establish internal commitments, modify processes and templates, and embed new partners.
Change management is not a quick win, and for our adoption of new approaches to outlast the pandemic, it requires us to move with urgency together.