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Planning and Implementing Large Cardiovascular Outcomes Studies: Opportunities & Challenges

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Overview 

 

 



This Solution Provider Archive Webinar is brought to you by DIA in cooperation with Cytel.

Background

International regulators are calling sponsors to increasingly conduct CV outcomes studies. The costs necessitated by the additional trials will be measured in the $100’s of millions of dollars per program.  The full impact to be felt by every sponsor, of any size engaged in therapeutic areas where cardio-related events are a concern.

Add Increased Complexity to Increased Costs

Implementation and support complexity levels typically go up across the board, beginning with effectively managing the hurdles of combining data from multiple studies and then supporting the need for thoroughly integrated analysis and reports.

The greatest costs and resource strains will apply to (naturally) the biggest, most important trials - CV outcome trials (CVOT).  Assessing necessity, design, and timing of CVOT trials is of critical strategic importance. 

With some sponsors the experienced resources exist but they’re already stretched across multiple programs.  Other developers don’t have the capabilities, resources and tools in the first place.

Background Info: Relevant FDA Guidance

Diabetes trials in particular heavily employ cardiovascular outcomes studies.  Click here for a link to relevant FDA Guidances.

Relevant FDA Guidance: Evaluating  Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes

Featured Topics 

  • Designing non-inferiority trials for CV outcome studies
  • Including adaptations: sample size re-estimation, population enrichment, superiority switch
  • Event modeling, interim analysis and study end forecasting, interim simulations, predicitive interval plots
  • Describe strategies to address pre and post-marketing requirements

Special Offers 

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Contact Information 

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Archived Webinar Details
Carolyn Callahan
DIA North America
Phone +1.215.442.6194
Fax +1.215.442.6199
Carolyn.Callahan@diahome.org

Technical Requirements 

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Presenter(s) 

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Agenda  

Day 1 Tuesday, Oct 22, 2013

  • 11:00AM - 11:59PM

    Planning and Implementing Large Cardiovascular Outcomes Studies: Opportunities & Challenges

    Speaker(s):

    • Planning and Implementing Large Cardiovascular Trials - Paul Strumph and Zoran Antonijevic
      Paul Strumph, MD
      Vice President, Clinical Development
      Lexicon Pharmaceuticals, United States
    • Zoran Antonijevic, MSc
      Senior Director, Strategic Consulting
      Cytel, Inc., United States

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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.

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