Living Textbook Update Kevin Weinfurt Coordinating Center - - PowerPoint PPT Presentation

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Living Textbook Update Kevin Weinfurt Coordinating Center - - PowerPoint PPT Presentation

Living Textbook Update Kevin Weinfurt Coordinating Center Communications staff Proposed Organization Introduction Design Conduct Reporting/Dissemination Introduction What is a Pragmatic Clinical Trial? Engaging


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SLIDE 1

Living Textbook Update

Kevin Weinfurt Coordinating Center Communications staff

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SLIDE 2
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SLIDE 3

Proposed Organization

  • Introduction
  • Design
  • Conduct
  • Reporting/Dissemination
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SLIDE 4

Introduction

  • What is a Pragmatic Clinical Trial?
  • Engaging Stakeholders and Building

Partnerships to Ensure a Successful Trial

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SLIDE 5

Design

  • Sample Selection
  • Intervention and Comparison Groups
  • Randomization Schemes: Choosing Between Individual and

Cluster Designs

  • Choosing and Specifying Endpoints
  • Statistical Considerations/Analysis Plan
  • Ethics & Regulatory Considerations in Identifying and Enrolling

Participants

  • Data Access and Collection
  • Planning for Data Safety and Monitoring
  • Registration With ClinicalTrials.gov
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SLIDE 6

Conduct

  • Startup
  • Recruitment
  • Data Collection
  • Potential Changes That Might Occur
  • Data Safety and Monitoring
  • Monitoring for Stability of Intervention and

Comparison Groups

  • Data Analysis
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SLIDE 7

Reporting/Dissemination

  • Reporting Findings From PCTs
  • Special Considerations for Reporting PCTs
  • The PCT Reporting Template
  • Examples
  • Data Sharing and Promoting Transparency
  • Dissemination Strategies for Different

Stakeholders