Special issue of Journal of Biopharmaceutical Statistics 2011

Special issue of Journal of Biopharmaceutical Statistics on multiplicity and adaptive design issues in pharmaceutical statistics (June 2011). For more information about this special issue, visit the Journal of Biopharmaceutical Statistics web site.

Guest editors

Dr. Alex Dmitrienko (Eli Lilly and Company) and Prof. Martin Posch (Medical University of Vienna).


Peter Westfall, Ananda Manage. How well do multiple testing methods scale up when
both n and k increase?

Gerhard Hommel, Frank Bretz, Willi Maurer. Multiple tests based on ordered p-values: A historical survey and applications in medical research.

Mohammad Huque, Mohamed Alosh, Rafia Bhore. Addressing multiplicity issues of a composite endpoint and its components in clinical trials.

Julia Soulakova. Comparison of gatekeeping and other testing methods for identifying superior drug combinations in bi-factorial designs with isotonic parameters.

Takashi Sozu, Tomoyuki Sugimoto, Toshimitsu Hamasaki. Sample size determination in superiority clinical trials with multiple co-primary correlated endpoints.

Brian Wiens. Multiple testing procedures in two pivotal clinical trials for approval of a new pharmaceutical product.

Olivier Guilbaud, Pär Karlsson. Confidence regions for Bonferroni-based closed tests extended to more general closed tests.

Sandro Gsteiger, Frank Bretz, Wei Liu. Simultaneous confidence bands for non-linear regression models with application to population pharmacokinetic analyses.

Alex Dmitrienko, George Kordzakhia, Ajit Tamhane. Multistage and mixture parallel gatekeeping procedures in clinical trials.

Thomas Brechenmacher, Jane Xu, Alex Dmitrienko, Ajit Tamhane. A mixture gatekeeping procedure based on the Hommel test for clinical trial applications.

Alex Dmitrienko, Julia Soulakova, Brian Millen. Three methods for constructing parallel gatekeeping procedures in clinical trials.

Nigel Stallard. Group-sequential methods for adaptive seamless phase II/III clinical trials.

Gernot Wassmer. On sample size determination in multi-armed confirmatory adaptive designs.

Georg Gutjahr, Martin Posch, Werner Brannath. Familywise error control in multi-armed
response-adaptive two-stage designs.

Cyrus Mehta, Ping Gao. Population enrichment designs: Case study of a large multinational trial.

Sue-Jane Wang, James Hung, Robert O’Neill. Regulatory perspectives on multiplicity in adaptive design clinical trials throughout a drug development program.


U.S. Food and Drug Administration. Guidance for industry: Adaptive design clinical trials for drugs and biologics. February 2010.