RESTON, Va.--(BUSINESS WIRE)-- Aptiv Solutions, a biopharmaceutical and medical device development services company, and leader in adaptive clinical trial design, simulation and execution, announced today the latest release in its proprietary suite of adaptive trial software: ADDPLAN® 6.0 PE. This groundbreaking software was specifically developed to support adaptive design & simulation for population enrichment trials.
“It is well recognized that innovation in clinical trial design is a critical component of modern day product development,” said Pat Donnelly, Chairman and Chief Executive Officer at Aptiv Solutions. “ADDPLAN® is a cornerstone of our differentiation and the launch of this specific adaptive design software for population enrichment is a significant advance in the design and execution of adaptive trials. With this latest release, Aptiv Solutions further advances its leadership in the design and execution of adaptive trials. We are the market leader and the only service provider capable of offering comprehensive adaptive clinical trial services.”
There is a growing interest among regulators and sponsors in using personalized medicine approaches that allow for targeted patients to receive maximum benefit from the correct dose of a specific drug. Previously, this was largely a trial-and-error approach, but with ADDPLAN® 6.0 PE, this approach can be better modeled and implemented. The specific interest is in the development of targeted therapies directed to biomarker-guided patient subgroups in order to detect a superior treatment effect or a differential safety profile. Population enrichment designs offer a specific adaptive trial methodology to study the effect of experimental treatments in various sub-populations of patients under investigation, and in the wider population. If at the interim analysis a population sub-group is shown to more likely benefit from a specific treatment, a pre-planned adaptation to enrollment can be implemented to study the sub-population of interest.
Reinhard Eisebitt, Executive Vice President of the Innovation Centre at Aptiv Solutions commented, “The launch of ADDPLAN® 6.0 PE will bring significant value to both sponsor companies and payer/providers and is another key indicator of the innovation that Aptiv Solutions is bringing to the market.”
ADDPLAN® 6.0 PE provides the statistical methodology, simulation and analysis tools for adaptive clinical trials that include an enrichment design and is the first fully validated adaptive design software with this functionality to be made available to the market. It has significant application in helping define the true health economic benefit of novel and existing therapies.
Importantly, the US Food and Drug Administration is reported to be working on a Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products. The availability of ADDPLAN® 6.0 PE will be of significant interest to companies developing targeted therapies for specific sub-populations of patients, whether they are defined by predictive biomarkers, specific pathologies, genomics or demographic factors.
About Aptiv Solutions
Aptiv Solutions is a global biopharmaceutical and medical device development services company focused on recognizing, understanding and enabling clients to capitalize on rapid and fundamental changes facing companies developing products in the pharmaceutical, biotech and medical device market. The company offers clients an extensive portfolio of innovative services including adaptive clinical trials, translational research services, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization. Aptiv Solutions has over 850 professionals in North America, Europe, the Middle East, Japan, and Australia. Visit the website at www.aptivsolutions.com.
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Aptiv Solutions
Gillian DellaCioppa, +1 508-597-6000
Director of Marketing
[email protected]
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