ADDPLAN® Software. ADDPLAN is fully validated, 21 CFR Part 11 compliant statistical software, for the design, simulation and analysis of adaptive clinical trials. It combines the key features of planning and conducting a sequentially planned clinical trial within a user-friendly interface. ADDPLAN is currently used by regulatory agencies, including the including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals & Medical Devices Agency (PMDA), as well as over fifty top pharmaceutical and medical device companies and numerous leading academic researchers. It is the first statistical software package to incorporate a majority of the requirements in the FDA “Draft Guidance on Adaptive Design for Clinical Trials for Drugs and Biologics”. Examples include the use of multiple comparison procedures for multi-armed adaptive trials, including treatment selection designs, flexible combination of clinical research phases, and patient enrichment designs.
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References in zbMATH (referenced in 2 articles )
Showing results 1 to 2 of 2.
- Schmidt, Rene; Faldum, Andreas; Witt, Olaf; Gerß, Joachim: Adaptive designs with arbitrary dependence structure (2014)
- Zhu, Li; Ni, Liyun; Yao, Bin: Group sequential methods and software applications (2011)