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Adaptive by Design - Adaptive Trials for Clinical Data Management

Adaptive by Design - Adaptive Trials for Clinical Data Management

Date: October 7, 2021
Time: 08:00 AM PDT | 11:00 AM EDT | 17:00 CET | 20:30 IST

OVERVIEW 

This webinar will discuss adaptive clinical trials from the point of view of the clinical data manager. This presentation will be based on the 2019 FDA Guidance entitled, "Adaptive Designs for Clinical Trials of Drugs and Biologics". First, basic statistical and clinical trial concepts will be reviewed. These concepts are important for understanding adaptive trial design and implementation. The benefits and liabilities of adaptive clinical trials will be presented. The principles of adaptive clinical trials will be identified. Several types of
adaptive clinical trials will be described from the perspective of the clinical data manager. Finally, the importance of maintaining trial integrity will discussed.

The clinical research professional will leave this webinar with an understanding
of adaptive trial design as well as practical knowledge of the implementation of
adaptive clinical trials.

WHAT YOU'LL LEARN 

  • Understand basic statistical concepts underlying adaptive designs
  • Identify the benefits and liabilities of using adaptive designs
  • Understand the principles of adaptive clinical trials
  • Describe the different types of adaptive clinical trials
  • Understand the importance trial integrity in adaptive clinical trials

WHO SHOULD ATTEND

This webinar was created for the intermediate to advanced clinical research
professional, but also has some basic concepts for beginners.

WHAT ARE THE BENEFITS 

Attendees will gain an understanding of the basic concepts of adaptive clinical
trial design and implementation. In addition, an understanding of the role of
clinical data management in adaptive clinical trials will be presented.

MEET THE PRESENTER

Tim Breen, former Director of Clinical Research Informatics, Hoosier Cancer Research Network
Tim was the Director of Clinical Research Informatics for the Hoosier Cancer Research Network for over nine years and retired in 2019. He has been involved in clinical research for more than 20 years. His interests are in the quality of data and the development of methods to efficiently maintain quality data. He has been the Chair of the SCDM Webinar Committee since 2009.

WEBINAR REGISTRATION

Group Registration Policy: Any group registration allows up to 10 people to attend the webinar and to complete the webinar assessment. Credits will be granted on an individual basis upon successful completion of the assessment by the registered participants.

Refund Policy: Participants will receive a full refund if notice is provided in writing via post or email one week prior to the webinar date. If cancellation occurs within the week prior the webinar, participants will be allowed to apply 50% of the webinar fee to the next offering of the same webinar. No refunds will be offered after that time.

Need Support?
Technical support:
Click on the help button on the bottom right, select contact support and email the BlueSky team with any technical issues.
Otherwise e-mail directly to support@blueskyelearn.com or call +1-888-705-6002 for immediate help.
General support:
The SCDM Learning team is here to help. Contact us at learning@scdm.org or call +32 232 024 87