Key Multiplicity Issues in Clinical Trials II

Instructor

Dr. Alex Dmitrienko (Mediana Inc).

Information

This Instant Short Course will be released in the summer of 2017.

Full-day course

Total duration: NA.

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$999.00 (U.S. dollars)
7-day access for up to 25 attendees

Related courses

See also Key Multiplicity Issues in Clinical Trials I.

Outline

The course gives a review of more advanced multiplicity problems arising in clinical trials with multiple objectives, e.g., primary and secondary objectives based on multiple endpoints, dose-control tests and patient populations. It introduces a class of multiple testing procedures developed for addressing these problems known as gatekeeping procedures. The course offers a well-balanced mix of theory and applications with case studies based on real clinical trials. It also discusses regulatory considerations and software implementation of multiplicity adjustment methods using SAS and R software.

Textbook

Multiple Testing Problems in Pharmaceutical Statistics (Edited by Alex Dmitrienko, Ajit Tamhane and Frank Bretz). Chapman and Hall/CRC Press, 2009.

Live courses

This Instant Short Course is based on single-day or two-day live courses that have been offered at the following meetings:

  • U.S. Food and Drug Administration, Rockville, Maryland, 2008.
  • International Multiple Comparison conference, Tokyo, Japan, 2009.
  • Deming Conference, Atlantic City, NJ, 2010.
  • FDA/Industry Statistics Workshop, Washington, DC, 2011.
  • FDA/DIA Statistics Forum, Washington, DC, 2012.
  • ENAR Spring Meeting, Orlando, FL, 2013.
  • IBS German Region Meeting, Berlin, Germany, 2013.

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