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Virtual

Nov 29, 2022 2:00 PM - Nov 30, 2022 6:30 PM

(Central Europe Standard Time)

Adaptive Design in Clinical Trials

This course will help participants better understand statistical concepts in clinical trial design, data analysis and reporting in clinical development.

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Overview

Adaptive designs in clinical trials are by now a well-established tool to efficiently design clinical trials. In some scenarios they offer the flexibility of modifying trials during the trial, after one or more interim analyses, i.e., once partial data are collected.

Using real-world examples from the pharmaceutical industry, this virtual course provides a comprehensive review of the concepts and methods underpinning adaptive clinical designs and examines their application in drug development. It will also provide an overview of data monitoring and regulatory guidance relevant to adaptive designs.

 

Featured topics

  • Basic statistical concepts and principles
  • Randomization and clinical trial design
  • Adaptive clinical trials
  • Regulatory guidance
  • Interim analysis and Data Monitoring Committee (DMC)
  • Master protocols in drug development

 

Who should attend?

This course is for pharmaceutical industry professionals working in:

  • Medical affairs
  • Regulatory affairs
  • Clinical development
  • Clinical study project management
  • Biopharmaceutical development
  • Biostatistics
  • Statistical programming

 

Learning objectives

  • This course will help participants better understand statistical concepts in clinical trial design (such as e.g. randomization or adaptive designs), data analysis and reporting in clinical development
  • Participants will also gain insights into the regulatory guidance when applying adaptive designs in clinical development
  • This course provides input on how to assess if an adaptive design is appropriate to implement for given research questions and context
  • Participants will learn how to communicate to higher management to convince them to switch to the adaptive design
  • This course explains what potential statistical and non-statistical resources should participants have available to help plan, run, and report an adaptive clinical trial

 

TECHNICAL REQUIREMENTS

To test your system compatibility, please click on the link: https://diaglobal.zoom.us/test

Operating Systems

  • Windows: XP 32-bit (SP3), 2003, Vista 32-bit/64-bit, Windows 7 32-bit/64-bit
  • Mac OS X: 10.5, 10.6, 10.7
  • Linux: 32-bit Ubuntu 10.x,11.x 32-bit Fedora 15/16, 32-bit Red Hat 5/6, 32-bit OpenSuSE 11.4

Minimum System Requirement

  • Windows: Processor – Requires Sun Java 5 or higher, Recommend ActiveX be enabled for Internet Explorer
  • Mac OS X: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access
  • Linux: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access

Browsers

  • Windows: Internet Explorer 6, 7, 8, 9, (Win7 Only), Firefox latest (32-bit), Chrome latest
  • Mac OS X: Safari 4-Mar; Firefox 2/3/3.5
  • Linux: Mozilla 1.7, Firefox 2/3/3.5

Internet Connection Speed

  • Windows: Intel or AMD processor (1GHz or faster), At least 512 MB RAM (at least 2 GB RAM for Vista)
  • Mac OS X: Intel processor, At least 512 MB RAM
  • Linux: At least 512 MB RAM

Display

  • 800x600 pixel resolution or greater (1024x768 pixels recommended)

 

Digital Learning Catalog

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