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Co-conveners of the newly formed Decentralized Trials & Research Alliance, Amir Kalali, MD and Craig Lipset discuss the alliance as well as how COVID-19 has impacted the industry.
The COVID-19 pandemic has severely impacted the conduct of clinical trials back years due to restrictions on in-person visits to investigator sites. Over the past 11 months, the industry has responded with an accelerated adaptation to decentralized trial methodologies.
In December 2020, Decentralized Trials & Research Alliance (DTRA) was launched to unite trial stakeholders with a mission of to make trial participation more accessible by advancing policies and best practices. In this interview, co-conveners of DTRA, Amir Kalali, MD and Craig Lipset discuss the new alliance as well as how COVID-19 has impacted the industry.
Andy Studna: How did the idea for starting DTRA first come about?
Amir Kalali: Craig has been actively leading and advocating for decentralized research for more than a decade now, while I have been supporting convening and knowledge-sharing on decentralized trials for years through the CNS Summit. These conversations have been thoughtful and productive, but barriers to meaningful adoption have remained. We founded DTRA to go beyond the conversation by creating a neutral and sustaining space for collaboration to address the barriers to decentralized research. As a result, the organization and our approach draw on my experience in global clinical development, and creating non-profit and neutral collaborations, Craig’s experience in decentralized trials and leading consortia in clinical research, and both of our trusted networks of leaders that seek to go farther together.
AS: Would you have come up with the idea for DTRA if COVID-19 had never happened?
Craig Lipset: Actually, like it has done in so many cases, COVID-19 complicated the effort. Planning for DTRA preceded the pandemic, COVID-19 delayed the DTRA in several ways as leaders in the field were heavily focused on executing study continuity strategies across the biopharmaceutical industry relying upon decentralized research tools. By mid-year, however, the urgent need for the benefits that could result from DTRA’s collaborative effort was clear, and leaders were ready to step forward.
AS: How do you anticipate achieving maximum collaboration between stakeholders involved in clinical trials?
Kalali: I think that our ‘big tent’ approach is an accelerator for collaboration. While some collaborations convene a single stakeholder group in order to address their specific challenges, DTRA is a multi-stakeholder initiative, which includes regulators, pharma sponsors, service providers, technology companies, site networks and patient organizations. Among our first needs as an organization was to establish our priority areas, a process which could have been challenged by our stakeholders potentially having highly divergent needs. But the priorities for decentralized research across stakeholders proved to have a remarkable degree of consistency, which provided DTRA with a shared vision and strong focus moving forward.
AS: What problems within clinical trials do you think COVID-19 has amplified and how can they be solved?
Lipset: Well, it’s clear that COVID-19 has underscored how fragile the clinical research enterprise can become–and it has contributed to that fragility. Despite the degree of shared resources and infrastructure across the sector, no single stakeholder owns or controls all of the components necessary for a successful drug development program. And, when pandemic-related lockdowns took hold across the globe, many study sites were unable to remain open and research participants were unable to leave their homes for study visits. But the research community was able to maintain continuity by drawing on other stakeholders that stepped forward, and embracing decentralized research solutions that had been available, but had struggled for adoption. We think this experience demonstrates how collaboration makes our shared ecosystem stronger, reduces risk, and drives progress.
AS: What are your goals for DTRA moving forward?
Kalali: DTRA goals include progressing shared solutions to common challenges while creating a community among the leaders in decentralized research, and to that end, the membership of DTRA has identified four priority areas. These include definitions, removing the ‘Tower of Babel’ created through sector—or organization-specific jargon by commonly endorsed archetypes of decentralized research, as well as key performance indicators. We must also use our collective experience to understand and share best practices that reduce risk and improve decentralized trial execution.
Lipset: They also include gathering data and information from across the community to promote knowledge sharing/education by providing educational resources for all stakeholders to improve awareness and appreciation for the impact of decentralized research; and identifying and removing remaining barriers to the global conduct of decentralized research, charting pathways to resolution. It’s truly exciting to see the dedicated support for these priorities and the collaborative effort needed to move forward from a group that now includes more than 100 committed stakeholders.
Andy Studna is an Assistant Editor for Applied Clinical Trials. He can be reached at firstname.lastname@example.org.