Front Range Chapter: Hybrid/Decentralized Trials

When:  Mar 20, 2023 from 05:00 PM to 06:30 PM (MT)
Associated with  ACRP Front Range Chapter

Front Range Chapter: Hybrid/Decentralized Trials: Operationalizing for Success Today and Planning for the Future (ACRP 2022 Replay)

This presentation is a webinar replay from the ACRP Conference Library

March 20, 2023 | 5:00 p.m. - 6:30 p.m., MT

Program Description:

Opportunities for robust data collection in decentralized clinical trials have increased as the landscape has become more digitized. Studies collecting endpoints in the home via electronic Clinical Outcome Assessments (eCOA) have evolved beyond self-reported Patient Reported Outcome (PRO) assessments, to include an expanding list of Performance Outcome (PerfO) assessments and connected device technologies. In addition to offering a more convenient patient experience, these developments may yield more comprehensive and representative data because it represents a broader window of data capture than endpoints collected during a traditional clinical visit (e.g., 1 week of experience vs. 1 hour of a clinic visit). Our experience operationalizing decentralized trials with multiple clinical outcome endpoints has provided important lessons that will benefit clinical research professionals across disciplines and roles. A unified experience for patients and clinical staff is vital to a trial’s success, and all scientific and regulatory priorities must be balanced with time demands associated with study conduct and site and patient burden. This presentation will start with case examples of hybrid/decentralized trial visit schedules and move to a discussion of what will be required by sites and patients to operationalize the study during start-up and for ongoing study support (e.g., device registration, training, helpdesk). Finally, the session will discuss the future of clinical trials, including the path to regulatory approval of digital endpoints, overall, and potentially in support of patient-focused drug development.

Learning Objectives:

  1. Understand the landscape and components of simple and complex hybrid/decentralized trials
  2. Prepare for operation of decentralized trials in start-up and on-going support
  3. Recognize the future evolution towards regulatory approval of digital endpoints and patient-focused drug development

Speakers: Lindsay Hughes, PhD, MS
                  Principal Scientific Advisor

                  Matthew Johnson, MSE
  Vice President, Wearables/Digital Biomarkers


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Laurie Burnside