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Spire

Nov 08, 2018 12:45 PM - Nov 09, 2018 4:00 PM

750 First Street NE, Washington, DC 20002

Master Protocol Workshop

Overview

NEW Workshop!

The modernization of clinical trials is driven by the need to address important clinical questions more efficiently while decreasing costs. Master protocols (MAPs), including basket, umbrella, and platform trials, provide a method to answer multiple questions in one overall trial structure. Although MAPs require increased planning efforts and coordination, they provide an opportunity to efficiently address a broader set of objectives than would be possible in an independent trial. DIA’s new Master Protocol Workshop will examine the common features and the advantages and limitations of different types of MAPs, along with lessons learned from recent master protocol clinical trials such as LUNG-MAP, I-SPY 2, EPAD, DIAN-TU, and others. Experts will discuss best practices for master protocol study design, collaboration - including navigating public-private partnerships and international considerations, and operationalization.


Highlights

  • An in-depth look at ISPY2 and EPAD
  • Discussions on various design features within a platform trial including randomization, blinding, treatment comparisons, and more
  • Explore best practices for operationalizing master protocols and how master protocols impact internal stakeholders’ processes
  • Networking Reception at the conclusion of day one to continue the conversation and make connections


Additional Resources


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Continuing Education

Who should attend?

Professionals involved in:

  • Clinical Research and Development
  • Study and Protocol Design
  • Biostatistics
  • Regulatory Affairs
  • Clinical Operations
  • Clinical Data Management
  • Project Management
  • Strategic Planning
  • Oncology, Immunology, CNS, Rare Disease therapeutic areas

Learning objectives

At the conclusion of this conference, participants should be able to:

  • Discuss the concepts, benefits, and efficiencies of utilizing master protocols in clinical trial design
  • Identify the collaborations needed to successfully design, fund, and execute a master protocol including incentives and challenges for each stakeholder group
  • Describe current trials utilizing master protocols and the strategic, design, and operational aspects of eachs
  • Explain key considerations in planning, coordination and regulatory compliance when adopting master protocols

Program Committee

  • Scott M Berry, PhD
    Scott M Berry, PhD President and Senior Statistical Scientist
    Berry Consultants LLC, United States
  • Abby  Bronson, MBA
    Abby Bronson, MBA Vice President, Patient Advocacy and External Innovation
    Edgewise Therapeutics, United States
  • Craig H Lipset, MPH
    Craig H Lipset, MPH Managing Partner
    Clinical Innovation Partners, United States
  • Daniel  Millar, MBA
    Daniel Millar, MBA Senior Director, Strategic Business Transformation
    Johnson & Johnson, United States
  • Lisa  LaVange, PhD
    Lisa LaVange, PhD Professor and Chair, Department of Biostatistics
    University of North Carolina At Chapel Hill, United States

Digital Learning Catalog

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