Catching up on DCTs with Craig Lipset, from Clinical Innovation Partners

We caught up with Craig Lipset to gain his unique perspectives on the importance of seizing the benefits of Decentralized Clinical Trials (DCTs) in light of the pandemic – and how the field needs to maintain momentum in their adoption for the future. Craig Lipset is involved in the industry through multiple avenues, and is a founding member of and advisor of Clinical Innovation Partners, which provides advisory services for the adoption of innovative approaches in clinical research and medical development. 

PF: It is a pleasure to have you with us, Craig Lipset. Could you give us a brief introduction about yourself?

CL: I work as an advisor, board member, educator and advocate for those looking to identify and scale innovative solutions in clinical research. As an advisor, I am working together with pharma/biotech, investors and technology organizations on strategy. I serve on the boards for both private companies as well as non-profit organizations such as the Decentralized Trials & Research Alliance, as well as the MedStar Health Research Institute. I am on the faculty as adjunct assistant professor in health informatics at Rutgers University where I teach a graduate course on clinical trial innovation. And I am a patient advocate serving as Vice President of the Foundation for Sarcoidosis Research.

PF: What is the most exciting area of clinical operations you are currently working on?

CL: Scaling pandemic-related changes, and sustaining the willingness to innovate. The community has broken through the adoption of areas such as decentralized trials, and it is exciting to embed and scale these with leaders. At the same time, the willingness to adopt and change has been remarkable during the pandemic, and our receptiveness to taking thoughtful risks needs to outlast the pandemic.

PF: What have been the notable clinical trials trends in the past year?

CL: Clear trends to-date have included our use of digital and data in trials (from design through execution) together with our momentum to bring patient-centricity from rhetoric to action (from partnering for insights in design to meaningful steps toward addressing experience, access, and representation).

PF: What has been driving these trends?

CL: Most of these opportunities have been able to show a compelling business case or have benefited from enterprise momentum within life sciences organizations. Some are leveraging cultural shifts, but here it is particularly urgent to demonstrate business value in order for the work to outlast fleeting winds of change.

PF: Where should pharma and biotech be focusing their activities on in light of these priorities?

CL: Establish sustaining commitments internally, leveraging today’s momentum to create progress that will outlast when momentum starts to fade. Establish cultures that are pro-innovation and thoughtful risk-taking so that we do not need to wait for another pandemic to drive a spike in adoption of solutions that otherwise sat untouched.

PF: Which innovations or new technology excites you right now/in the near future?

CL: As we have seen a wave of adoption in decentralized trials solutions within life sciences, we are now beginning to see “the next tier” of innovators emerge. When platforms are embedded and “core DCT offerings” are a part of the new normal, it is exciting to see “what’s next” in this field. Examples will include how we are extending “beyond the home” in new DCT models that open participation from pharmacy to retail clinic, from community health centers to local doctor’s offices, from mobile sites to pop-up sites.

PF: Without giving too much away, can you give us a brief overview of what you will be looking to explore at the Clinical Operations East Coast Strategy Meeting and why it is important for 2022?

CL: I am looking forward to sharing more about what lies ahead as “DCT version 1.0” become clear and stabilized, and we begin to see more of the next generation of DCT solutions and approaches. What will these mean for the evolution of roles in clinical research?

PF: Is there anything else you would like to add about the future of DCTs?

CL: The rate-limiter for all of these amazing opportunities today is our culture and willingness to change and adopt. Here, incremental change matters and we need not wait for “big events” to make a meaningful difference in our organizations.

Mayalee Che, Senior Producer, Proventa International

Join Proventa International’s Clinical Operations Strategy Meeting in Boston to gain further insights on the growing importance of DCTs and smart technology in navigating the future of clinical development. Meet and network with key stakeholders, and participate in closed roundtable discussions on the leading topics of the industry.