Reston, Virginia, February 28, 2013 – Aptiv Solutions, a biopharmaceutical and medical device development services company, and the leader in adaptive clinical trial design, simulation and execution, reports on the key findings arising from an Executive Roundtable, facilitated by the Tufts Center for the Study of Drug Development (CSDD) on ‘Leveraging Adaptive Trial Designs to Do Better Science and Reduce Development Cost and Time’.
The full day meeting, sponsored by an unrestricted grant from Aptiv Solutions, was attended by senior executives from over 20 companies, including 11 of the top 15 pharmaceutical companies. Also in attendance was a representative from the FDA and a former EMA regulator, both of whom are well-versed in adaptive clinical trial methodologies. The key objective of the roundtable was to identify how adaptive design can impact modern day product development. The findings indicate that adaptive design has a critical role to play in delivering development efficiency and productivity, and that pharmaceutical company executives need to unite to drive wider adoption across the industry. The key findings are:
Adaptive design has a critical role to play in modern protocol planning and needs to be even more widely adopted across industry. Central to this concept is scenario planning through trial simulation which acts as a critical ‘stress test’ for protocol design and a key tool to demonstrate value of adaptive design to multiple stakeholders.
Simple adaptive designs should be considered part of ‘Good Clinical Practice’ and routinely applied in both exploratory and late phase trials as an insurance policy to either stop early for futility or re-assess the sample size to save the trial. Evidence from leading companies shows that futility stopping saves upwards of $100 million per annum when applied at the portfolio level.
Different types of adaptive design must be deployed in exploratory phase trials where key decisions on dose, endpoint and patient population have to be made before pivotal trials can start. Futility stopping in phase III indicates product failure of which one of the root causes is poor dose selection at phase II.
Phase II adaptive dose-finding trials must be implemented widely to ensure that late phase attrition is addressed robustly across industry. Both FDA and EMA are urging pharmaceutical companies to use these techniques more widely and are ready to provide support.
These newer designs will require re-appraisal of the technology and operational processes used to deliver such trials. Integrated technologies are now readily-available, but their adoption will need the support of pharmaceutical executives to drive the necessary change within their companies to ensure success.
It is important to note that adaptive design is not a replacement for other industry change programs looking at clinical trial efficiency such as risk-based monitoring or the better use of investigator networks. Rather, it is complementary, and coupled with these initiatives it will dramatically change the product development paradigm.
“The decade of protocol optimization is upon us”, said Ken Getz, Senior Research Fellow, and Director of Sponsored Programs at Tufts CSDD. “Adaptive design is a critical component of protocol optimization and the biopharmaceutical industry needs to understand how to assess the utility of adaptive design methodology very early in the development process.”
Pat Donnelly, Chairman and Chief Executive Officer of Aptiv Solutions commented: “The impact of adaptive design on the efficiency and productivity of drug, diagnostic and medical device development is very significant. We are excited to be working alongside the Tufts CSDD, regulatory authorities and other industry colleagues to help deliver the value that adaptive design will bring to our industry.”
About Aptiv Solutions
Aptiv Solutions is a global development services company that is focused on enhancing clinical trial decision-making, efficiency and productivity in the pharmaceutical, biotech and medical device markets. 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, Eastern & Western Europe, Israel, and Japan. Visit the website at www.aptivsolutions.com.