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Tutorial #1: Subgroup Analysis in Clinical Trials: Statistical Considerations for Interpretation of Study Findings and Design Issues

Apr 6 2014 9:00AM - Apr 6 2014 12:00PM | Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road, North Bethesda, MD 20852 USA

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Overview 

Clinical trials enroll subjects expected to benefit from the treatment under investigation, although the magnitude of their benefits, when it exits, may vary by their background characteristics. For a completed trial that demonstrates treatment efficacy in the overall population, subgroup analysis are usually carried out for checking consistency of treatment effect across subgroups for proper interpretation of study findings and for providing guidance on treatment use. However, observed heterogeneity in treatment effect across subgroups can be, partly at least, due to chance factors; furthermore, true heterogeneity, when present, may not be detected by statistical tests due to their low power. This tutorial considers these issues related to subgroup analyses for a completed trial and investigates whether subgroup findings can be supportive for those of the overall population. In addition, it discusses statistical considerations for the design and analysis of a confirmatory clinical trial with the objective of establishing efficacy claims in a targeted subgroup and the overall population.


At the conclusion of this tutorial, participants should be able to:

  • Identify the impact of chance findings on the interpretation of subgroup analysis findings
  • Describe how to critically assess findings of testing for treatment-by-subgroup interaction and their utility in determining the treatments use
  • Discuss how to handle statistical considerations, including study power and multiplicity issues, for the design and analysis of a clinical trial with claim for a targeted subgroup

Instructor(s) 

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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