Title:
FDA Guidance on Adaptive Design for Clinical Trials
Date(s) And Time(s):
Mar 26 2010 8:00AM - Mar 26 2010 5:00PM
Location:
National Labor College
10000 New Hampshire Avenue
Silver Spring, MD 20903
Interest Area(s):
Clinical Data Management/ eClinical,Clinical Safety/Pharmacovigilance,Clinical Research,Professional Education, Training & Development,Quality Assurance/Quality Control,Regulatory Affairs,Statistics
Overview:
Build a Solid Foundation in the Regulatory Aspects of Adaptive Designs.
There has been increasing interest in applying adaptive clinical trials throughout the various stages of clinical development. This conference will provide an overview of the FDA draft guidance on the topic of adaptive designs, and an opportunity for discussion of some topics involved with the implementation of adaptive clinical trial design in drug development and approval. The FDA will summarize the guidance content and highlight areas where they feel comments to the official Docket would be most helpful. There will be opportunities to seek clarifications of issues raised in the guidance. Study sponsors will discuss practical examples of designing and conducting clinical trials using adaptive designs for regulatory approval and focus on how to address potential concerns about adaptive designs.
Due to their complexity, adaptive design development programs require more (and earlier) planning and documentation. The conference will present how this planning should be summarized and discussed with the FDA prior to implementing an adaptive trial.
Conference Objectives
• Transmit a general understanding of the content of the draft guidance
• Ensure attendees understand how to formally submit comments on the draft guidance to the FDA Docket
• Provide solid understanding of adaptive design issues and the contexts for their use that are of greater or lesser concern to FDA. Potential issues include operational bias, design induced bias, necessary multiplicity adjustments,difficulties in result interpretation, and the potential effectsof eliminating the time to thoughtfully evaluate data during a drug development program. The FDA will outline types of adaptive methods and stages of drug development where adaptive clinical trials may be advantageous in the drug development process
• Present practical issues about conduct of adaptive trials by those who had experiences in performing adaptive trials, with particular emphasis on maintaining the integrity of adaptive trials
Learning Objectives:
At the conclusion of this meeting, participants should be able to:
• Transmit a general understanding of the content of the draft guidance;
• Explain how to formally submit comments on the draft guidance to the FDA Docket; and
• Discuss adaptive design issues and the contexts for their use that are of greater or lesser concern to FDA.
Target Audience:
Potential stakeholders interested in this guidance include the pharmaceutical industry, academic clinical investigators, contract research organizations, and other regulatory agencies. The conference will present perspectives from each of these groups.
Professionals involved in:
• Biostatistics
• Clinical research
• Compliance
• Data analysis
• Quality assurance/Quality control
• Regulatory affairs
Event Code:
10020
Contact Information:
Event Information: Contact JoAnn Boileau at the DIA office by telephone
+1.215.442.6175, fax +1.215.293.5940 or email JoAnn.Boileau@diahome.org.
Venue: Contact Lauren Samet, +1.301.628.5606
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