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Factors in Designing & Evaluating Clinical Trials for App-Based Interventions
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Factors in Designing & Evaluating Clinical Trials for App-Based Interventions
As digital mental health interventions are becoming an integral part of our healthcare landscape, there is a need to better understand digital clinical trials and how to evaluate their outcomes to support clinical decision making. In this webinar, Dr. Sara Morimoto, PsyD will share her expertise in developing and testing app-based mental health interventions. In this context, she will discuss design aspects and other factors that may require special consideration when evaluating clinical outcomes for app-based treatments.
Objectives:
- Review the requirements for FDA Clearance of Prescription Digital Therapeutics (PDT)
- Review considerations in the evaluation of clinical trials for digital therapeutics (DTx)
- Discuss the importance of clinically meaningful data in the development and assessment of DTx and impact on patient care.
Sarah S. Morimoto, PsyD
Associate Professor – Spencer Fox Eccles School of Medicine at the University of Utah, Salt Lake City, UT
MoreSarah Shizuko Morimoto, PsyD, is Associate Professor, Population Health Sciences, Division of Health Systems Innovation and Research, as well as Director of the Neurotherapeutics Lab and Director of Cognitive Remediation in Psychiatry at the University of Utah School of Medicine in Salt Lake City. Dr Morimoto’s research encompasses the full range of digital cognitive remediation intervention development, from identifying targeted and clinically relevant cognitive deficits to developing computerized paradigms and conducting clinical trials. Dr Morimoto received her PsyD in clinical psychology from the PGSP-Stanford PsyD Consortium through Palo Alto University and Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, California. She completed a clinical internship at Beth Israel Deaconess/Massachusetts Mental Health Center/Harvard Medical School Department of Psychiatry, Boston, Massachusetts, a fellowship in clinical neuropsychiatry at New York-Presbyterian/Weill Cornell Medical Center, and a fellowship in geriatric mood disorders at Weill Cornell Institute of Geriatric Psychiatry at Weill Cornell Medical College.
Scott Schepers, PhD (OPDC)
Medical Science Liaison
Sara Morimoto is a paid consultant of Otsuka Pharmaceutical Development & Commercialization, Inc.
Scott Schepers is an employee of Otsuka Pharmaceutical Development & Commercialization, Inc.
Disclaimer: PsychU is supported by Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), Otsuka America Pharmaceutical, Inc. (OAPI), and Lundbeck, LLC – committed supporters of the mental health treatment community. The opinions expressed by PsychU’s contributors are their own and are not endorsed or recommended by PsychU or its sponsors. The information provided through PsychU is intended for the educational benefit of mental health care professionals and others who support mental health care. It is not intended as, nor is it a substitute for, medical care, advice, or professional diagnosis. Health care professionals should use their independent medical judgement when reviewing PsychU’s educational resources. Users seeking medical advice should consult with a health care professional. No CME or CEU credits are available through any of the resources provided by PsychU. Some of the contributors may be paid consultants for OPDC, OAPI, and / or Lundbeck, LLC.
August 2024 US.CORP.X.24.00250Related Events
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