ADDPLAN White Paper


Sources of Error in Adaptive Trials and Exploring FLEX ADVANTAGE White Papers

Our ICON Insights will help you understand and successfully address the complexities of adaptive trial design and execution.

Optimise Clinical Development to Reduce Costs

ADDPLAN - the most widely used vendor adaptive design tool* in the pharma industry.

High attrition rate in phase III trials, lengthy development programs, and increasing development costs all demand a smarter approach to drug development. Adaptive design, identified in FDA's critical path initiative as one way to improve trial efficiency, can add value to all phases of drug development.

In exploratory phases, adaptive designs are used to combine development phases and improve resource allocation. In confirmatory trials, they enable early stopping, change of allocation rates, and reassessment of the sample size, patient subgroups or specific treatment arms. With better data and improved decision making, adaptive designs can increase the probability of success and decrease development time.

Accurate dose selection early in drug development is critical to late-phase success. With ADDPLAN DF software from ICON, the process of designing dose-finding trials is now more accurate and more efficient. Using ADDPLAN DF, dose-finding studies can be designed, simulated and analysed under a variety of statistical methodologies, including the FDA and EMA-qualified MCP-Mod approach.


Specialist Expertise

  

Reinhard Eisebitt
Executive Vice President, ICON Adaptive Trials Innovation Centre

Reinhard oversees a team of US and EU based adaptive design experts, who work closely with clients to design and conduct adaptive trials, and with industry partners to develop new and innovative methods in drug development. Prior to joining ICON, he was managing director of ClinResearch GmbH, a full service CRO specialising in the planning, execution and reporting of adaptive clinical trials. He is also co-founder of ADDPLAN GmbH, the first commercial software package for the design, simulation, and analysis of adaptive trials.


Andy Grieve
Vice President, ICON Adaptive Trials Innovation Centre

Andy is a Biostatistician with over 35 years experience in drug discovery, pre-clinical toxicology, pharmaceutical development, clinical development phases I-IV, marketing, health economics, production. He specialises in applying Bayesian statistics with a particular interest in adaptive designs.


The benefits of Adaptive Design Trials