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It is the first statistical software package to incorporate a majority of the requirements in the FDA “Draft Guidance on Adaptive Design for Clinical Trials for Drugs and Biologics”.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.
What’s New in ADDPLAN?
ADDPLAN 6.1, released in March 2014, enables the use of surrogate endpoints to expedite interim analysis decisions in adaptive clinical trials. Trials utilizing surrogate endpoint analysis to select treatment arms require a different statistical method than those using the clinical endpoint. With this release, ADDPLAN is the first software to include the appropriate statistical methods for the use of surrogates in interim analysis decisions. It is a powerful tool for implementing innovative designs for survival based trials, such as those in oncology or cardiovascular disease, to improve drug development decision-making.
ADDPLAN 6.1 utilizes a variant of the p-value combination method in a closed test procedure to account for repetition of patients in the exploratory and confirmatory phases. The approach enables the use of surrogates in survival (or time-to-event) designs in both the multiple comparison and the population enrichment settings. As a unique feature, ADDPLAN 6.1 simulates how the use of surrogate versus primary endpoints impacts trial outcomes and operational requirements.
ADDPLAN is available in the following modules:
- ADDPLAN BASE: Adaptive group sequential designs and sample size re‐estimation
- ADDPLAN MC: Adaptive multiple comparison procedures
- ADDPLAN PE: Adaptive population enrichment designs
- ADDPLAN DF: Adaptive dose finding designs (including MCP-Mod)