Aptiv Solutions has announced the release of ADDPLAN® DF, an innovative software that designs, simulates, and analyzes Phase 2 dose finding studies to make them more efficient and effective.
ADDPLAN® DF is the latest product in the ADDPLAN® family that includes a series of products for adaptive confirmatory trials.
ADDPLAN® DF is a fully-validated design and analysis tool based on MCP-Mod methodology (a combination of Multiple Comparison Procedures and Modeling) and covers dose finding designs for establishing Proof of Concept and determining the optimum target dose to select for Phase 3 trials.
This tool will enable drug developers to remove a number of the uncertainties inherent in Phase 2 dose finding trials and improve critical decisions on dose-selection, which will directly impact the probability of success in Phase 3.
Currently half of Phase 3 trials fail, in part because of poor dose selection in Phase 2. Regulators, pharmaceutical companies and industry groups recognize that more robust Phase 2 studies are required to improve dose selection and this is the stimulus driving the development of ADDPLAN® DF.
“The consequences of improving dose selection should be measured in terms of the success rates of subsequent Phase 3 trials,” says Professor Andy Grieve, Senior Vice President, Clinical Trial Methodology for Aptiv Solutions and co-author, with Tobias Mielke and Parvin Fardipour, of a new white paper on the critical importance of dose finding trials.
Professor Grieve continued, “The business value of improving dose selection can amount to billions of dollars across a product portfolio and importantly deliver an increased number of novel medicines to patients.”
There has been a recent increase in the adoption of innovative designs in exploratory phase trials stimulated by vocal support from the FDA and EMA. “Getting it right at Phase 2” has been a rallying call from both regulators and industry for some time and the availability of ADDPLAN® DF will significantly help to achieve this objective.
In July, ADDPLAN® DF was pre-released in beta version to a top 5 pharma company that served as the prime development partner for the software. Two additional large pharma customers have also received the software as founding members of the ADDPLAN® DF Consortium announced earlier this year. The software will be available for purchase by other interested stakeholders in mid-October.
“Among the many advantages we see with ADDPLAN® DF,” says Professor Grieve, “is its adaptive analysis and modeling capability. Using the design engine, the optimal allocation rates for a robust dose-estimation can be calculated. The simulation engine allows the verification of characteristics of the chosen design, and the analysis engine enables data analysis using different multiple comparison procedures, modeling approaches and the combined MCP-Mod approach. This creates the optimum method to select the dose for confirmatory Phase 3 studies.”
The benefits of ADDPLAN® DF are applicable to mid-size and large pharmaceutical companies taking novel products through Phase 3, as well as biotech companies looking to increase the value of their early stage assets and to partner at Phase 2.
A further application is in medical device development where different strengths of a specific stimulus need to be evaluated.
This release of ADDPLAN® DF is the first in a series of novel methodologies for use in Phase 2 clinical trials. Subsequent versions will be released that deliver additional benefits to this critical phase of exploratory development.
The white paper titled ‘ADDPLAN® DF - An Advanced Tool for Optimizing Dose Selection in Exploratory Drug Development’ is available at http://www.aptivsolutions.com/addplan-df-landing-page/.