ENAR Webinar:
Regulatory Perspective on Subgroup Analysis in Clinical Trials
Friday, December 4, 2015
10:00 am - 12:00 pm Eastern (9:00-11:00 am central)
Register
Presenters:
Dr. Mohamed Alosh & Dr. Kathleen Fritsch
Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA
Description:
For a confirmatory clinical trial that established treatment efficacy in the overall population, subgroup analysis aims to investigate the extent of benefits from the therapy for the major subgroups. Consequently, findings from the subgroup analysis play a major role in interpreting the trial results. This presentation focuses on two areas related to subgroup analysis in a confirmatory clinical trial: (i) investigating consistency of treatment effect across subgroups, and (ii) designing a clinical trial with the objective of establishing treatment efficacy in a targeted subgroup in addition to the overall population. The presentation also outlines the regulatory guidelines for subgroup analysis in such trials and provides examples of clinical trials where subgroup analysis played a role in determining the population for treatment use.
Registration Fee Per Login:
The Webinar Committee of the ENAR Regional Advisory Board (RAB) is coordinating this ongoing series of 1- to 2-hour webinars given by renowned experts. The webinars are planned to be broadly available and we encourage groups at your institution or workplace to participate together. WebENARs provide excellent learning opportunities for students and professionals alike.Registration fees are determined by membership category of the individual who registers. Please note as a benefit of ENAR membership you may participate in one webinar per year at no charge.
- ENAR Student Member: $25
- ENAR Regular Member: $45
- Non-Member: $65
Webinar connection instructions will be emailed to you after registration. Look for an email with “WebENAR Access Instructions” as part of the subject line; it may have been filtered to your Spam or Trash folder. If you do not receive this email, please email ENAR directly: enar@enar.org.
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Lynn Eberly
University of Minnesota
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