The I-SPY-2 trial, which involves 800 patients with advanced breast cancer, uses an adaptive design as well as genetic and biological marker analysis to screen multiple investigational therapies simultaneously.
The Biomarkers Consortium, the public-private partnership running the five year trial, explained that: “Evaluation of multiple drugs concurrently allows investigators to quickly measure effectiveness.”
The consortium is collaborating on I- SPY 2 with the Foundation for the National Institutes of Health (FNIH), the National Institutes of Health (NIH), the FDA, several biopharmaceutical firms and now Quintiles.
In an announcement last week the world’s largest contract research organization (CRO) said it will donate $2.6m over the next four years, which is roughly 10 per cent of the trial’s estimated overall running cost.
Quintiles will also provide management guidance for the study according to spokesman Phil Bridges, who told Outsourcing-pharma.com how the new collaboration will work.
“Quintiles executives will have the opportunity to consult directly with the co-leaders of the trial, Dr. Laura Esserman and Dr. Don Berry, and work in partnership FNIH, the FDA and NCI to advance the interests of patients.”
He went on to explain that while “there is no immediate new business offering that will result from Quintiles’ association with I-SPY 2, though many aspects of the trial overlap with initiatives we have underway.”
Bridges cited Quintiles capabilities in biomarker development, adaptive trials, and utilization of electronic health records for data capture as examples such synergies.
This echoed a press statement by Quintiles CEO Dennis Gillings who said: “Multi-party collaboration, adaptive trial design, biomarker use, and point-of-care data access are major steps in the right direction.
Anna Barker, former Deputy Director of the National Cancer Institute (NCI), an original designer of I-SPY 2 and current Board Member of other participating group, QuantumLeap, was equally upbeat about Quintiles involvement.
She said that: “Quintiles brings the best in clinical trial management practices to this effort to dramatically reduce the time and cost of bringing new therapies to market.”
The study’s co-principal investigator, Laura Essermanof the University of California, San Francisco was similarly enthusiastic, suggesting that: “Because Quintiles works with hundreds of biopharmaceutical companies and healthcare organizations around the world, it can help disseminate I-SPY 2 innovations.
“We’ve set up a system where everyone can learn more quickly. Our goal is to reduce costs and time-to-market for new drugs that can make a difference in patients’ lives, first for women with breast cancer, then for other cancers as well.”