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17 Nov 2021 | 02:30 PM GMT

Digital measures in Clinical Trials: Selection & Validation assessment

Anchored by:

Kris Karson
SVP, Corporate Development
ATROPOS HEALTH
George Platings
Director of Business Development
UMOTIF

Participants:

George Platings Director of Business DevelopmentuMotif
George Platings
Director of Business DevelopmentuMotif
Kris Karson SVP, Corporate DevelopmentAtropos Health
Kris Karson
SVP, Corporate DevelopmentAtropos Health
Chandana Fitzgerald President, CommunityHLTH
Chandana Fitzgerald
President, CommunityHLTH
Conor Hayes Co-Founder Techvie SoftwareMunster Technological University
Conor Hayes
Co-Founder Techvie SoftwareMunster Technological University
Hiromasa Mori CNS Solution OwnerKoneksa
Hiromasa Mori
CNS Solution OwnerKoneksa
Julia Lakeland Chief Product OfficeruMotif
Julia Lakeland
Chief Product OfficeruMotif
Kim Soltmann Executive Director Sales DevelopmentWorldwide Clinical Trials
Kim Soltmann
Executive Director Sales DevelopmentWorldwide Clinical Trials
Samantha Reed Independent ConsultantSPR Advisory LLC
Samantha Reed
Independent ConsultantSPR Advisory LLC
Tim Ruckh Digital Health Clinical Data Collection LeadAstraZeneca
Tim Ruckh
Digital Health Clinical Data Collection LeadAstraZeneca
Willie Muehlhausen Co-FounderSafira Clinical Research Limited
Willie Muehlhausen
Co-FounderSafira Clinical Research Limited

About this Meeting

Digital measures (both digital-enabled measures and novel digital biomarkers) have the potential to form part of clinical development programs, but there are still a lot of questions to be addressed before this becomes a reality for sponsors and CROs. Join this meeting to discuss with other thought leaders the main challenges to successfully select and validate digital measures for clinical trials:

  •  Important factors to consider when selecting the right digital measures in a clinical trial (e.g costs, regulatory requirements, patient adoption, etc) and tools that can help, like the DiMe’s library of digital endpoints. 
  •  Challenges when selecting the right digital measures to use & how the selection process looks like (role of the sponsor vs. digital vendor) 
  •  Technical and clinical validation of digital measures: who is responsible for this validation, requirements of the different stakeholders (e.g sponsors, CROs, regulatory bodies, physicians, etc), validation of software vs. hardware, how to deal with software updates/iterations and how to improve the current validation process.
  •  Standardization of understanding/interpretation across the field: what is the role of initiatives like the DATAcc, EVIDENCE and the V3 Framework from DiMe or the Digital Biomarker Discovery Pipeline?