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15 Feb 2023 | 03:45 PM GMT

Masterclass: Endpoints and Control Arms in Trials for DTx

Anchored by:

Acacia Parks
VP Regulatory Compliance and Engineering
AVANIA

Participants:

Acacia Parks VP Regulatory Compliance and EngineeringAvania
Acacia Parks
VP Regulatory Compliance and EngineeringAvania
Chandana Fitzgerald President, CommunityHLTH
Chandana Fitzgerald
President, CommunityHLTH
AP
Acacia Parks Fractional Chief Science OfficerFound
AP
Acacia Parks
Fractional Chief Science OfficerFound
Emanuela Offidani Director of Clinical Science Lumos Labs
Emanuela Offidani
Director of Clinical Science Lumos Labs
Francesca Wuttke Founder & CEOnen Health
Francesca Wuttke
Founder & CEOnen Health
Jessica Lake Director of Medical AffairsBig Health
Jessica Lake
Director of Medical AffairsBig Health
Jordan Silberman Dir of Clinical Analytics & ResearchElevance Health
Jordan Silberman
Dir of Clinical Analytics & ResearchElevance Health
Renae Beaumont Associate Professor of PsychologyWeill Cornell Medicine
Renae Beaumont
Associate Professor of PsychologyWeill Cornell Medicine
Richelle Flanagan Co-FounderMy Moves Matter
Richelle Flanagan
Co-FounderMy Moves Matter
Simon Bock Market Access ManagerTiefenbacher Pharmaceuticals
Simon Bock
Market Access ManagerTiefenbacher Pharmaceuticals
Tarolyn Carlton Senior DirectorOtsuka Pharmaceutical Companies (U.S.)
Tarolyn Carlton
Senior DirectorOtsuka Pharmaceutical Companies (U.S.)

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.

Proving clinical efficacy is one of the biggest challenges for DTx companies. However, it is key to getting buy-in from stakeholders. When designing a clinical trial for a DTx solution, selecting the right endpoints and control arms is very important to be commercially successful. What endpoints and control arms will help show the value to the different stakeholders (e.g. payers, healthcare professionals, investors, etc.)? 

Join this masterclass led by the expert in evidence generation for DTx and Digital Health, Acacia Parks (Fractional Chief Science Officer, Found), who will walk us through:

  • Control arms in RCTs for DTx: what are the different approaches to control conditions in RCTs evaluating DTx?  How can you select the right comparators for your solution? Are sham apps a good option? What control arms are accepted by regulators for DTx? 
  • Differences between objective/subjective, primary/secondary/exploratory, and health economics endpoints 
  • How do I know what are the best endpoints for my solution? How can digital health companies select and measure the right endpoints for their clinical trials? 
  • Aligning the selection of control arms and endpoints with the commercial (e.g. claims) and regulatory strategies. What are the right control arms and endpoints that will help you convince: 1) payers, 2) regulators, 3) physicians.
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.