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ADDPLAN 6.1 for Surrogate Endpoint-Based Adaptive Clinical Trials

By CIOReview | Wednesday, March 26, 2014

RESTON, VA: Aptiv Solutions, a biopharmaceutical and medical device development services company focused on enhancing clinical trial decision-making, has released ADDPLAN 6.1. This is the first statistical software to enable the use of surrogate endpoints to hasten the interim analysis decisions in adaptive clinical trials, according to the company.

ADDPLAN 6.1 comes as the latest enhancement to the ADDPLAN family of software for design, simulation and analysis of adaptive clinical trials. It is a 21 CFR Part 11 compliant software that combines the key features of planning and conducting a sequential clinical trial with a user friendly interface. The application incorporates the use of multiple comparison procedures for multi-armed adaptive trials, including treatment selection and patient enrichment designs, as well as a flexible combination of clinical research phases.

This tool can be made use of to implement innovative plans for survival based trials, similar to the ones in oncology or cardiovascular disease, to improve drug development decision-making. Surrogate endpoints can also be used for interim selection of treatment arms or subgroup selection in population enrichment designs.

As a unique feature, ADDPLAN 6.1 simulates the usage of surrogate versus primary endpoints’ impact on trial outcomes and operational requirements.