In this episode, Craig Lipset demystifies the meaning of patient centricity in clinical research.
Craig and I had a rich conversation around what it means to design a patient centric protocol, challenges with “direct to patient” approaches, tools and models to engage treating physicians and encourage them to share research opportunities with their patients and much more.
Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development.
He is an advisor to technology and biopharmaceutical companies, leading universities, and the venture community, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement.
Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics).
During that time, Craig designed and launched multiple industry firsts — from the first fully remote/virtual clinical trial for a new medicine to the first returning of results and data to research participants.
He currently serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, and, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Craig is an Adjunct Assistant Professor in Health Informatics at Rutgers University.
Please join me in welcoming Craig to the Clinical Trial Podcast
YouTube: Clinical Innovation Partners
[2:20] Health 2.0 and Quantified Self meets clinical trials and personalized medicine
[4:39] Lack of full transparency with the patients on the use real world data and real world evidence
[8:34] Informed consents are anything but transparent. We could do better with patient engagement when it comes to use of data
[12:55] What does patient centricity mean?
[15:48] Patient involvement in trial design and how patients opinions can help protocol design
[20:46] Patient centric approach doesn’t mean more time and budget
[12:45] Downside of “direct to patient” approach to raise awareness and importance of find smart, engaging and inclusive ways that help treating physicians to engage and share research opportunities with patients
[25:09] Tools and models for treating physicians to engage, participate, and say “Yes”
[28:30] Patient focused drug development and endpoints that are meaningful to patients
[30:29] FDA’s patient focused drug development sessions and playbooks for drug developers for working with patient advocacy groups in different disease areas
[32:06] Getting alignment on endpoints
[34:14] Sharing study results with patients via patient friendly summaries
[36:42] Sharing patient’s personal data that was acquired during a clinical trial and possibility of feeding the patient’s data back into their electronic medical record (EMR)
[40:16] Clinical research as a care option
[43:40] Patient portals, open data and APIs attached to the data
[47:24] Craig stays current with the help of his LinkedIn community
[56:02] Craig’s morning routine
People, resources and organizations mentioned
Ciitizen collects, summarizes, and provides digital access to full medical records from everywhere a patient has received care
Department of Health and Human Services – The access right, health apps, & APIs
Circuit Clinical was born from the experiences of a physician conducting clinical research in his busy private practice. From the core belief that patients prefer to learn about clinical research from healthcare providers they trust, came the vision for Circuit Clinical, one of the largest Integrated Research Organizations (IRO) in the US
Javara is an Integrated Research Organization (IRO) changing the clinical research experience and expanding access to research for patients and providers.
Elligo Health Research brings clinical research to physician practices and accelerates the development of medical devices and therapies.
Robert Wood Johnson Foundation
Freakonomics: A Rogue Economist Explores the Hidden Side of Everything (P.S.) by Steven D. Levitt (Author), Stephen J. Dubner (Contributor)
The Patient Will See You Now: The Future of Medicine Is in Your Hands by Eric Topol MD
The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care by Eric Topol MD
Sapiens: A Brief History of Humankind by Yuval Noah Harari
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