RESTON, Va. -- (BUSINESS WIRE) -- 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:
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.