DIA: Considerations for Innovative Trial Design in CNS

Considerations for Innovative Trial Design in CNS 

Join us at DIA 2021 on Sunday, June 20, 2021, at 12:00 pm ET for an insightful presentation featuring ERT’s Kristen Sowalksy, Director, Director, Clinical Science and Consulting – Wearables and Digital Biomarkers. 

It is clear that what was a slow trend towards decentralized healthcare and clinical research has recently undergone a major inflection point due to the COVID-19 pandemic and consequently, the ability to support decentralized trials and implement remote and unsupervised assessments is a high priority. Clinical outcomes assessments (COAs) may present unique challenges, but also important opportunities related to their suitability and validity for remote conduct, as well as their practical implementation. The continued and successful application of both traditional clinical evaluations and emerging digital technologies is critical to the evaluation of novel therapies and consequently, the field must identify and promote good practice in this area.

Learning Objectives

  • Review practical examples and case studies of remote and decentralized clinical trial implementation
  • Identify good practice in the validation and implementation of clinical outcome assessments (COAs) including clinician reported outcome (ClinRO), performance outcome (PerfO), and Digital Health Technology (DHT)/Passive Monitoring assessments

Speakers: 

  • Kristen Sowalsky
    Director, Clinical Science and Consulting – Wearables and Digital Biomarkers, ERT, United States
  • Daniel Debonis
    Principal, Signant Health, United States
  • Chris Reist
    Medical Director, Psychiatry and Behavioral Science, Science 37, United States
  • Christopher Edgar
    Chief Scientific Officer, Cogstate, United States