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29 Mar 2023 | 02:45 PM GMT

Masterclass: Design and Control Conditions for Clinical Trials of Digital Health Solutions

Anchored by:

David Hohenschurz-Schmidt
Research Associate
IMPERIAL COLLEGE LONDON

Participants:

David Hohenschurz-Schmidt Research AssociateImperial College London
David Hohenschurz-Schmidt
Research AssociateImperial College London
Maggie O'Donovan Senior Consultant, Advisory and InsightsHLTH Inc
Maggie O'Donovan
Senior Consultant, Advisory and InsightsHLTH Inc
Arshia Gratiot Founder and CEOEupnoos
Arshia Gratiot
Founder and CEOEupnoos
Benoit Tyl Medical Advisor, Integrated Care CardiologyBayer AG
Benoit Tyl
Medical Advisor, Integrated Care CardiologyBayer AG
Gazal Vakili Director, Digital Health InnovationDainippon Sumitomo Pharma
Gazal Vakili
Director, Digital Health InnovationDainippon Sumitomo Pharma
Jordan Silberman Dir of Clinical Analytics & ResearchElevance Health
Jordan Silberman
Dir of Clinical Analytics & ResearchElevance Health
Jorge Juan Fernández García Chief Innovation OfficerHospital Clínic Barcelona
Jorge Juan Fernández García
Chief Innovation OfficerHospital Clínic Barcelona
Lochlann McCabe Account Manager - BiopharmaVWR, part of Avantor
Lochlann McCabe
Account Manager - BiopharmaVWR, part of Avantor
Louise O'Mahony Head of Customer SuccessEXi
Louise O'Mahony
Head of Customer SuccessEXi
Renae Beaumont Associate Professor of PsychologyWeill Cornell Medicine
Renae Beaumont
Associate Professor of PsychologyWeill Cornell Medicine
Tracy Lahey Strategy & Business Development ManagerAmgen
Tracy Lahey
Strategy & Business Development ManagerAmgen

About this Meeting

Each Masterclass is led by an expert anchor in their field as they dive into their specialty topic in front of a small intimate audience of 8-12 participants. Masterclasses also have an interactive element, allowing you a safe space to share your thoughts and experiences as well as pose questions to the expert anchors.

Clinical efficacy is a crucial factor for the commercial success of Digital Health solutions. In order to demonstrate their value to stakeholders such as payers, healthcare professionals, investors, and others, it's essential to have a well-designed clinical trial that accurately captures the impact of the DTx solution.

Join this masterclass led by David Hohenschurz-Schmidt (researcher, therapist and DTx consultant, Imperial College London), where we will dive into the process of designing clinical trials for Digital Health solutions and how to select the right control conditions for every digital health solution: 

  • Types of studies that can be used for digital health solutions
  • Representativeness in the trial. How to wisely pick the participants of the study? Are there any tools to enrich the population (e.g. predicting who will be responders vs. non-compliers)?
  • Selecting the appropriate control conditions for Digital Health clinical trials: what are the different approaches for control conditions in RCTs for digital health? How can you determine the ideal comparators for your solution? Is the use of sham apps a viable option? What are the control arms accepted by regulators? 
  • Matching control arms and endpoints with commercial and regulatory strategies. How to select control arms and endpoints that will support your commercial claims and regulatory requirements to convince key stakeholders like payers, providers, and others?
We would like to remind you that our meetings are small and intimate sessions with a limited number of seats available, therefore we rely on your attendance and participation to ensure a high quality and valuable meeting for all. If you are confirmed for this meeting we ask if you can please ensure your attendance on the day.