FDA Guidance on Adaptive Design for Clinical Trials

Date(s) And Time(s):
Mar 26 2010 8:00AM - Mar 26 2010 5:00PM

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.

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Transmit a general understanding of the content of the draft guidance

· Ensure attendees understand how to formally submit comments on the draft guidance to the FDA Docket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 effects of eliminating the time to thoughtfully evaluate data during a drug development program. The FDA will outline types of

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· Transmit a general understanding of the content of the draft guidance

· Explain how to formally submit comments on the draft guidance to the FDA Docket.

· Discuss adaptive design issues and the contexts for their use that are of greater or lesser concern to FDA

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 affair

Event Information: Contact Constance Burnett at the DIA office by telephone

+1.215.293.5800, fax +1.215.442.6199 or email Constance.Burnett@diahome.org.

Venue: Contact Lauren Samet, +1.301.628.56

http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?pr...