Insights from Craig Lipset, Co-Founder of the Decentralized Trials & Research Alliance

Insights from Craig Lipset, Co-Founder of the Decentralized Trials & Research Alliance

Logo of the DTRA and photo of Craig Lipset courtesy of the Decentralized Trials & Research Alliance.

In this interview, Craig Lipset, Co-Founder of the Decentralized Trials & Research Alliance, discusses the Alliance’s new glossary for industry and more.

The global virtual clinical trials market is valued at $8.3 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 5.7 percent to reach $12.9 billion by 2030. The COVID-19 pandemic has significantly impacted the market and many clinical research organizations (CROs) were quick to embrace decentralization capabilities.

The Decentralized Trials & Research Alliance (DTRA) was launched near the end of 2020 with a mission to “enable collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials (DCTs) and research within life sciences and healthcare through education and research.”

DTRA organizational members include life sciences and research companies, technology and service providers, patient advocacy organizations, regulatory agencies and site networks.

The DTRA is currently working on twelve initiatives to help develop strategic solutions for DCTs through collaboration. At the end of August, the DTRA released the first initiative, the DTRA Glossary, to ensure that consistent terminology is used within and between organizations and to provide a lexicon to describe different archetypes of DCTs.

Xtalks learned more about the DTRA and its first initiative through an email interview with Craig Lipset, Co-Founder and Co-Chairman of the DTRA. Read on to learn more!

What led you and Dr. Kalali to jointly start the DTRA? Was the DTRA founded before the start of the pandemic?

Craig Lipset: In the years prior to the pandemic, leaders advancing decentralized trials would convene in conference panels to discuss shared challenges. The DTRA was born from those conversations, as opportunities for collaboration to address these challenges needed a space to progress.

Planning for the DTRA preceded the pandemic, but the launch was delayed until late 2020 as the leaders in decentralized research were called to rapidly introduce DCT-based countermeasures as lockdowns placed medicine development pipelines in jeopardy.

What are some specific improvements you have seen with DCT technologies and the way DCTs are conducted since the start of the pandemic?

Craig Lipset: At the start of the pandemic organizations needed to aggressively introduce decentralized tools and methods in order to sustain portfolios. Temporary measures such as SOP waivers and protocol deviations were needed, and study-specific tools were found from technology and CRO partners wherever feasible.

Today organizations have been stabilizing their approaches for decentralized research. SOPs, training and protocol templates have been updated, and large organizations from pharma to CROs have increasingly implemented enterprise-level approaches and strategies. These are key steps toward the sustainable future of decentralized research.

What benefits does an organization have from being a DTRA member?

Craig Lipset: DTRA Member Organizations are defining and leading the initiatives that will ease the global adoption of decentralized research and drive the next transformation in medicine development at scale. They are establishing the priorities and initiatives, and driving the delivery of high quality solutions meant for all. Members are also able to learn and connect from across the DTRA community, from the DTRA membership platform to the Annual Meeting.

Congratulations to the DTRA for releasing the DTRA glossary! In your opinion, were there any terms that the DCT community should pay particular attention to?

Craig Lipset: The DTRA Glossary is an important first initiative toward easing adoption by removing the noise and confusion associated with not understanding one another. Central to this is simply to define “decentralized clinical trials” as an expansive term meant to include a range of archetypes as well as the use of both novel technologies and services. It is then critical to define the decentralized research methods themselves, so that study teams, investigators and partners can remove ambiguity and support adoption.

What comes next for the DTRA? What is the next initiative the DTRA plans to release?

Craig Lipset: DTRA members are advancing a portfolio of initiatives meant to ease the global adoption of decentralized research. We will have a steady stream of initiative releases in the coming weeks and months following the DTRA Annual Meeting taking place November 6th to 9th in Boston.

In addition to his work at the DTRA, Craig also currently serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute. He is also an Adjunct Assistant Professor in Health Informatics at Rutgers University, and an Adjunct Instructor at the University of Rochester Center for Health & Technology. Craig was the Head of Clinical Innovation and Venture Partner at Pfizer and on the founding Operations Committee for TransCelerate Biopharma.