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  • Monday, Mar 10th
    11:00 AM – 12:35 PM ET
    Spotlight Session | Challenges in Clinical Trials Design [Non-CME]
    Location: Spotlight Theater
    SpotlightChallenges in Clinical Trial Design
  • Monday, Mar 10th
    11:00 AM – 11:05 AM ET
    Welcome and Introduction
    Location: Spotlight Theater
    Speaker: Donald E. Cutlip, MD, FACC – Beth Israel Deaconess Medical Center
    SpotlightChallenges in Clinical Trial Design
  • Monday, Mar 10th
    11:00 AM – 12:35 PM ET
    CHALLENGES IN CLINICAL TRIALS DESIGN
    Location: Spotlight Theater
    Moderator: Donald E. Cutlip, MD, FACC – Beth Israel Deaconess Medical Center
    Moderator: Jan Tijssen, PhD – Amsterdam University Medical Centers - University of Amsterdam
    SpotlightChallenges in Clinical Trial Design
  • Monday, Mar 10th
    11:05 AM – 11:13 AM ET
    Endpoints and Statistical Issues in Clinical Trials of Devices
    Location: Spotlight Theater
    Speaker: Jan Tijssen, PhD – Amsterdam University Medical Centers - University of Amsterdam
    SpotlightChallenges in Clinical Trial Design
  • Monday, Mar 10th
    11:13 AM – 11:21 AM ET
    Patients Perspectives in Analyses of Clinical Trial Endpoints
    Location: Spotlight Theater
    Speaker: Shelby D. Reed, PhD – Duke Clinical Research Institute
    SpotlightChallenges in Clinical Trial Design
  • Monday, Mar 10th
    11:21 AM – 11:29 AM ET
    State-of-the-Science for Observational Real World Data Comparisons
    Location: Spotlight Theater
    Speaker: Rania Hammami, MD – Military University Hospital of Sfax, Cardiology department
    SpotlightChallenges in Clinical Trial Design
  • Monday, Mar 10th
    11:29 AM – 11:37 AM ET
    What is the Win Ratio and When Should We Use It?
    Location: Spotlight Theater
    Speaker: Andrew D. Althouse, PhD – Medtronic
    SpotlightChallenges in Clinical Trial Design
  • Monday, Mar 10th
    11:37 AM – 11:45 AM ET
    Community-Based Complex Clinical Trials
    Location: Spotlight Theater
    Speaker: Jodi J. Akin, MS – Hawthorne Effect, Inc.
    SpotlightChallenges in Clinical Trial Design
  • Monday, Mar 10th
    11:45 AM – 11:53 AM ET
    Power Calculation for Non-Inferiority Studies
    Location: Spotlight Theater
    Speaker: Roseann M. White, MA – Your 3rd Opinion
    SpotlightChallenges in Clinical Trial Design
  • Monday, Mar 10th
    11:53 AM – 12:01 PM ET
    DEI in Trial Design | How We Control Enrollment
    Location: Spotlight Theater
    Speaker: Biljana Parapid, MD, PhD – Belgrade University School of Medicine
    SpotlightChallenges in Clinical Trial Design
  • Monday, Mar 10th
    12:01 PM – 12:09 PM ET
    Statistical Analytical Challenges 2025
    Location: Spotlight Theater
    Speaker: Roseann M. White, MA – Your 3rd Opinion
    SpotlightChallenges in Clinical Trial Design
  • Monday, Mar 10th
    12:09 PM – 12:17 PM ET
    Registry-Based Randomized Trials
    Location: Spotlight Theater
    SpotlightChallenges in Clinical Trial Design
  • Monday, Mar 10th
    12:17 PM – 12:25 PM ET
    Minimizing the Inferiority of Non-Inferiority Trials
    Location: Spotlight Theater
    Speaker: C. Michael Gibson, MD – Beth Israel Deaconess Medical Center
    SpotlightChallenges in Clinical Trial Design
  • Monday, Mar 10th
    12:25 PM – 12:35 PM ET
    Panel Discussion
    Location: Spotlight Theater
    Panel Moderator: Donald E. Cutlip, MD, FACC – Beth Israel Deaconess Medical Center
    Panel Discussant: Jodi J. Akin, MS – Hawthorne Effect, Inc.
    Panel Discussant: Andrew D. Althouse, PhD – Medtronic
    Panel Discussant: C. Michael Gibson, MD – Beth Israel Deaconess Medical Center
    Panel Discussant: Biljana Parapid, MD, PhD – Belgrade University School of Medicine
    Panel Discussant: Shelby D. Reed, PhD – Duke Clinical Research Institute
    Panel Discussant: Samantha Stone Barrett, MPH – IQVIA
    Panel Moderator: Jan Tijssen, PhD – Amsterdam University Medical Centers - University of Amsterdam
    Panel Discussant: William S. Weintraub, MD – MedStar Washington Hospital Center
    Panel Discussant: Roseann M. White, MA – Your 3rd Opinion
    SpotlightChallenges in Clinical Trial Design
  • Monday, Mar 10th
    12:35 PM ET
    Adjourn
    Location: Spotlight Theater
    SpotlightChallenges in Clinical Trial Design