Digital Clinical Trials: Avoiding Pitfalls with Intelligent Study Design

Why test a medical device in-clinic when patients will have to manage its use on their own from home?

This question directed Mi-Helper, Inc. Founder and CEO, Steve Schaefer, toward a digital clinical trial design for his migraine medical device. The resulting trial journey, which he assumed would be relatively linear, was anything but that. He had to figure out how to keep his participants engaged during a long run-in period and ensure they used his device properly at home. Resolving this complexity was essential for him to feel confident he would get the pristine data needed for regulatory submissions.

This webinar will focus on the design and deployment of a remote medical device trial. The trial’s sponsor, members of the study’s clinical operations team and an expert neurologist will provide a 360° view of the challenges associated with conducting medical device clinical trials. Panelists will also reveal the ways in which collaboration and iteration helped to identify and mitigate many of the study’s risks from the outset.

The attendees will get to learn more about the fundamentals of this clinical trial’s success: i) meticulous study design, ii) a comprehensive patient training program and iii) a real-human virtual site team that supported patients and kept them on track throughout their clinical trial journey.

Register for this webinar today to gain insights into designing digital clinical trials for medical devices and related challenges.

Speakers

(Moderator) Florence Mowlem, PhD, VP of Science, ObvioHealth

Florence Mowlem, PhD, is an expert eCOA scientist who has spent her career advising and guiding clinical research organizations on the digitalization and remote capture of clinical outcome assessments (COA), as well as the use of health devices in clinical trials. Dr. Mowlem holds a PhD in Social, Genetic, and Developmental Psychiatry from Kings College, which has informed her work on the scientific practice of digital endpoint capture. In her pivotal role at ObvioHealth, Dr. Mowlem works with both clinical and technology teams to optimize the implementation of eCOAs according to industry, regulatory and scientific best practices.

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Steve Schaefer, Chief Executive Officer, Mi-Helper, Inc.

Steve Schaefer has been transforming companies into global leaders in the healthcare, technology and life sciences industries for over 30 years. He has overseen the development of novel therapeutic medical devices, along with the clinical trials necessary for regulatory compliance, payer acceptance and market adoption. A former CPA, Steve has been responsible for seven successful exits representing over a billion dollars in transactions.

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Matty Lynch, Chief Operations Officer, ObvioHealth

Matty Lynch has over 30 years of experience in clinical research and has been stewarding ObvioHealth’s clinical operations team since 2017 through 60+ studies across 34 countries. In her previous roles, Matty developed and implemented clinical research programs for multi-therapeutic-area practices and hospitals across the country. A registered nurse, Matty has managed advanced research programs specializing in Phases I through IV device, post-approval, observational and decentralized clinical trials.

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Larry Charleston IV, MD MSc FAHS, Professor, Department of Neurology, Michigan State University; Co-Founder, Chief Consultant, and CEO, Charleston Health Neurology & Head Pain Consultants, PLLC

Dr. Larry Charleston IV, MD MSc FAHS, is an expert Neurologist specializing in headache medicine. After graduating from the Wayne State University School of Medicine, Dr. Charleston completed his neurology residency at Baylor College of Medicine, followed by a Headache and Facial Pain Fellowship at the Thomas Jefferson Headache Center. He is certified in Adult Neurology by the American Board of Psychiatry and Neurology (ABPN) and Headache Medicine by the United Council of Neurological Subspecialties (UCNS). Since 2017, Dr. Charleston has served as Chief Consultant for the Charleston Health Neurology & Head Pain Consultants, PLLC, which he also co-founded. He joined the Department of Neurology at Michigan State University in March 2021.

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Katelyn Landry, Migraine Clinical Trial Participant

Katelyn Landry is a wife, mother, school bus driver, and clinical trial participant who suffers with migraine disease. As part of her treatment journey, Katelyn has explored many different avenues to discover what works best for her and her migraine attacks—including, most recently, a fully remote medical device migraine clinical trial. She was drawn to participate in this trial because its digital study design made it convenient to do so—but, most importantly, to support research that helps individuals like her access therapeutics that work for them.

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