Key Multiplicity Issues in Clinical Trials I


Dr. Alex Dmitrienko (Mediana Inc).

Full-day course

Total duration: 6 hours 38 minutes.

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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 II.


The course gives a review of key multiplicity issues arising in clinical trials, including analysis of trials with multiple endpoints, dose-control comparisons and subgroups. It presents traditional multiplicity adjustment methods as well as recent advances in this area. 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.


Topics covered in this Instant Short Course:

  • Introduction. Duration: 27 minutes.
  • Module A. Clinical trial examples. Duration: 18 minutes.
  • Module B. Key concepts: Inferential goals, Error rate definitions, Classification of multiple testing procedures. Duration: 1 hour 5 minutes.
  • Module C. P-value-based multiple testing procedures I: Data-driven hypothesis ordering. Duration: 1 hour 48 minutes.
  • Module D. P-value-based multiple testing procedures II: Pre-specified hypothesis ordering. Duration: 1 hour 19 minutes.
  • Module E. Parametric multiple testing procedures. Duration: 46 minutes.
  • Module F. Simultaneous confidence intervals. Duration: 55 minutes.

Supplementary material

Download a ZIP archive with the list of references and links.


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.
  • U.S. Food and Drug Administration, Rockville, Maryland, 2014.

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