Key Multiplicity Issues in Clinical Trials I (Second Edition)


Dr. Alex Dmitrienko (Mediana Inc).

Full-day course

This Instant Short Course was released in July 2017.

Total duration: 7 hours 51 minutes.

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$1199.00 (U.S. dollars)
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Related courses

See also Key Multiplicity Issues in Clinical Trials II.


This Instant Short Course gives a comprehensive overview of traditional multiplicity problems with a single source of multiplicity in clinical trials (advanced multiplicity problems are discussed in Part II). This setting includes clinical trials with multiple endpoints, multiple dose-control comparisons and multiple patient populations. The course provides a detailed coverage of multiple testing procedures used in confirmatory Phase III trials with emphasis on recent developments in this area. The course offers a well-balanced mix of theory and applications with case studies based on real clinical trials in neuroscience, oncology, diabetes and other therapeutic areas. Practical advice from experts is presented and relevant regulatory considerations, including the recently released FDA and EMA multiplicity guidance documents, are discussed. Software implementation of multiple testing procedures introduced in the course based on SAS and R packages is also discussed.

What is new in the Second Edition?

This Instant Short Course was updated in June 2017.

  • New topics. Multiple updates throughout the modules included in the course and a new module on power calculations in clinical trials with multiple objectives. Updated case studies to provide examples of all common types of multiplicity problems in clinical trials.
  • New guidance documents. Detailed discussion of FDA and EMA multiplicity guidance documents released in 2017.
  • New software tools. Updated software implementation sections to introduce a new R package for implementing popular multiple testing procedures (Mediana package).


Topics covered in this Instant Short Course:

  • Introduction. Duration: 28 minutes.
  • Module A. Clinical trial examples (Phase III trials with multiple primary and co-primary endpoints, multiple dose-control comparisons, multiple patient populations). Duration: 19 minutes.
  • Module B. Key concepts: Inferential goals (at-least-one, all-or-none and global procedures), Error rate definitions, Classification of multiple testing procedures (single-step and stepwise procedures, nonparametric, semiparametric and parametric procedures). Duration: 1 hour 10 minutes.
  • Module C. Nonparametric and semiparametric multiple testing procedures I: Data-driven hypothesis ordering (Bonferroni, Holm, Hochberg and Hommel procedures). Duration: 1 hour 45 minutes.
  • Module D. Nonparametric multiple testing procedures II: Pre-specified hypothesis ordering (fixed-sequence, fallback and chain/graphical procedures). Duration: 1 hour 21 minutes.
  • Module E. Parametric multiple testing procedures (regular Dunnett and step-down Dunnett procedures). Duration: 44 minutes.
  • Module F. Simultaneous confidence intervals for commonly used multiple testing procedures (single-step and stepwise procedures). Duration: 58 minutes.
  • Module G. Power calculations in clinical trials with multiple objectives. Duration: 1 hour 6 minutes.

Supplementary material

Download the handouts for this Instant Short Course (PDF document).

Download the list of references used in this Instant Short Course (PDF document).

Download the SAS and R code used in this Instant Short Course (ZIP archive).


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

Analysis of Clinical Trials Using SAS (Second Edition) (Edited by Alex Dmitrienko and Gary Koch). SAS Press, 2017.

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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