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04 May 2022 | 02:45 PM GMT

Masterclass: How to design a Clinical Trial for your Digital Health product?

Participants:

Tessy Huss Director of Strategy , HLTH CommunityHLTH Community
Tessy Huss
Director of Strategy , HLTH CommunityHLTH Community
Adam Samson President, National Center Clinical TrialsAdvocate Health
Adam Samson
President, National Center Clinical TrialsAdvocate Health
AH
Ainslie Hatch Senior Director, Development TeamOtsuka Pharmaceutical Companies (U.S.)
AH
Ainslie Hatch
Senior Director, Development TeamOtsuka Pharmaceutical Companies (U.S.)
Brendan Staunton CEOAmara Therapeutics
Brendan Staunton
CEOAmara Therapeutics
Cathy Zaremba Director, Product MarketingBrightInsight
Cathy Zaremba
Director, Product MarketingBrightInsight
Chris Bergstrom PresidentAmalgamRx
Chris Bergstrom
PresidentAmalgamRx
Frank ONeill Director Systems EngineeringBioIntelliSense, Inc
Frank ONeill
Director Systems EngineeringBioIntelliSense, Inc
Gareth Jones VP, Strategic Business Dev & InvestmentZepp Health
Gareth Jones
VP, Strategic Business Dev & InvestmentZepp Health
Jordan Silberman Dir of Clinical Analytics & ResearchElevance Health
Jordan Silberman
Dir of Clinical Analytics & ResearchElevance Health
Klaudia Grechuta MedTech Coordinator at BI's Digital LabBoehringer Ingelheim
Klaudia Grechuta
MedTech Coordinator at BI's Digital LabBoehringer Ingelheim
Laura Lang Medical Science ManagerKaiku Health
Laura Lang
Medical Science ManagerKaiku Health
Marie Noel Achkar Digital Care Transformation Project LeadUCB
Marie Noel Achkar
Digital Care Transformation Project LeadUCB
Maxime Champain Search & Evaluation lead, External InnovationBiogen
Maxime Champain
Search & Evaluation lead, External InnovationBiogen
Randy Horton VP of Solutions and PartnershipsOrthogonal
Randy Horton
VP of Solutions and PartnershipsOrthogonal
Shwen Gwee Member of the Advisory BoardNew Enterprise Ventures
Shwen Gwee
Member of the Advisory BoardNew Enterprise Ventures
SE
Stephen Egan DirectorRediCare
SE
Stephen Egan
DirectorRediCare
Suzanne Clough Chief Medical OfficerAmalgamRx
Suzanne Clough
Chief Medical OfficerAmalgamRx
Thyago Ohana Digital Strategy & Capabilities LeadUCB Pharma
Thyago Ohana
Digital Strategy & Capabilities LeadUCB Pharma

About this Meeting

Are you struggling with trial design for your digital health products? Asking questions such as what are the right comparators or how to deal with product iterations? Keep reading, this masterclass is for you!   

Proving clinical efficacy is one of the biggest challenges for digital health companies. However, it is key to getting buy-in from stakeholders. How can we design trials for digital health tools so they are rigorously validated and regulated? Why shouldn’t we design clinical trials for digital health products using the same approach we have for drug trials? Join us in this masterclass led by Suzanne Clough (Chief Medical Officer, AmalgamRx) to learn more about:   

  • Study design and control arm: what types of studies can you use for digital health products? How can you select the right comparators?  
  • Study participants and recruitment: inclusion/exclusion criteria, sample size, socio-demographic groups, recruitment strategies, operational strategies, etc. 
  • Outcomes and endpoints 
  • How to approach the iterative nature of digital health products? Role of RWE and RWD?