DIAアカウントをお持ちの場合、サインインしてください。

サインイン

ユーザーIDをお忘れですか? or パスワードをお忘れですか?

Virtual Event

2023年11月21日 (火) 午前 9:00 - 2023年11月22日 (水) 午後 1:30

4051 Basel, Switzerland

Adaptive Design in Clinical Trials

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

概要

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 live training 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.

 

特集トピック

  • 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

 

参加対象

This virtual live training course is for pharmaceutical industry professionals working in:

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

 

学習目的

  • Recognize statistical concepts in clinical trial design (such as e.g. randomization or adaptive designs), data analysis and reporting in clinical development
  • Implement the regulatory guidance when applying adaptive designs in clinical development
  • Evaluate an adaptive design to determine if it is appropriate to implement for given research questions and context
  • Discuss how to communicate to higher management to convince them to switch to the adaptive design
  • Explain what potential statistical and non-statistical resources are required to plan, run, and report an adaptive clinical trial

 

Digital Learning Catalog

DIA Learning: eLearning Soultions
Download

最新情報や機会を逃さないで

DIAのメールを購読すれば、常に最新の業界情報やイベント情報を得ることができます。