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U062 - Does the Drug Really Work? Interpreting Clinical Trial Data

Sunday, February 18; 4:30 PM - 5:30 PM

Learning Objectives

Following this course, the attendee should be able to:

  • Discuss the basic design of conducting clinical trials, the advantages and disadvantages of clinical trials, and to more accurately interpret the data from clinical trials when presented in publications or at conferences.
  • Differentiate the various data analysis of clinical trial endpoints (intent to treat, last observation carried forward, etc) and the basic terminology to assess safety parameters in clinical trials.
  • Assess the impact and clinical relevance of clinical trial data into clinical practice. A hypothetical clinical trial will be presented to serve as an example of analyzing the various endpoints from the data.

Description

Many phase 2 and 3 clinical trial data are published and presented every year for a drug under investigation. The rigidity of the data is dependent on the type of statistical analysis used (intent-to-treat, last-observation-carried-forward, as-observed, etc). It is important for the clinician to understand how conservative the data was analyzed in order to formulate a meaningful clinical assessment. The clinician should also be able to define the various terminology used to assess safety (odds-ratio, hazard-ratio, relative-risk, etc). A hypothetical clinical trial will be presented as an example of analyzing the various endpoints from the data.

Disclosures

  • Yamauchi, Paul Steven, MD, PhD: AbbVie – C(H), SP(H); Amgen – A(H), C(H), I(Grants/Research Funding), SP(H); Celgene Corporation – C(H), I(Grants/Research Funding), SP(H); Dermira – A(H), I(Grants/Research Funding); Galderma USA – I(Grants/Research Funding), SP(H); Janssen-Ortho Inc. – C(H), I(Grants/Research Funding), SP(H); Leo Pharma Inc – I(Grants/Research Funding), SP(H); LEO Pharma, US – C(H); Lilly ICOS LLC – A(H), I(Grants/Research Funding); Medimmune – I(Grants/Research Funding); Novartis Pharmaceuticals Corp. – C(H), I(Grants/Research Funding), SP(H); Pfizer Inc. – C(H), I(Grants/Research Funding); Regeneron – C(H), I(Grants/Research Funding); Sandoz, a Novartis company – I(Grants/Research Funding);
Event Details
  • Date
    Sunday, February 18
  • Time
    4:30 PM - 5:30 PM
  • Location
    Room 3
  • CME Credits
    1.00
  • Type
Directors/Co-Directors
  • Paul Steven Yamauchi, MD, PhD, FAAD