Special issue of Therapeutic Innovation and Regulatory Science 2014

Special issue of Therapeutic Innovation and Regulatory Science (TIRS) on advances in clinical trial statistics (January 2014). For more information about this special issue, visit the TIRS web site.

Guest editors

Dr. Alex Dmitrienko (Quintiles) and Dr. Olga Marchenko (Quintiles).


J. Rick Turner. Statistics in Therapeutic Innovation and Regulatory Decision Making.

Lisa M. LaVange. The Role of Statistics in Regulatory Decision Making.

Olga Marchenko, Valerii Fedorov, J. Jack Lee, Christy Nolan, José Pinheiro. Adaptive Clinical Trials: Overview of Early-Phase Designs and Challenges.

Jeff Maca, Vladimir Dragalin, Paul Gallo. Adaptive Clinical Trials: Overview of Phase III Designs and Challenges.

Tom Parke, Vladimir Dragalin, Ibrahim Turkoz, Olga Marchenko, Virginia Haynes. Adaptive Design Applied to Identification of the Minimum Effective Dose in Schizophrenia: Simulations of Scientific and Commercial Value.

Sue-Jane Wang, H.M. James Hung. A Conditional Adaptive Weighted Test Method for Confirmatory Trials.

Fei Chen, José Pinheiro. Dose-Response Determination in Multistage Endpoint Clinical Trials.

Steven Snapinn, Qi Jiang. Remaining Challenges in Assessing Non-Inferiority.

C. Mallinckrodt, J. Roger, C. Chuang-Stein, G. Molenberghs, M. O’Kelly, B. Ratitch, M. Janssens, P. Bunouf. Recent Developments in the Prevention and Treatment of Missing Data.

Anastasia Ivanova, Gary L. Rosner, Olga Marchenko, Tom Parke, Inna Perevozskaya, Yanping Wang. Advances in Statistical Approaches to Oncology Drug Development.

Brian L. Wiens, Theodore C. Lystig, Scott M. Berry. Recent Statistical Contributions to Medical Device Development.

Lan Huang, Ted Guo, Jyoti N. Zalkikar, Ram C. Tiwari. A Review of Statistical Methods for Safety Surveillance.

H. Amy Xia, Qi Jiang. Statistical Evaluation of Drug Safety Data.