Quintiles to Support I-SPY 2 Breast Cancer Clinical Trial with $2.6 Million Donation
Quintiles announced today that it will contribute a total of $2.6 million over four years to support I-SPY 2, an adaptive clinical trial designed to develop breast cancer therapies twice as quickly and at one-fifth the cost of current methods. Current development costs typically exceed $1 billion and take 12 to 15 years to bring a single drug to market.
The I-SPY 2 clinical trial involves 800 patients with advanced breast cancer at time of primary diagnosis. It employs adaptive trial design and genetic and biological markers from individual patients’ tumors to screen multiple investigational therapies simultaneously. The evaluation of multiple drugs concurrently allows investigators to quickly measure effectiveness.
The design of the I-SPY 2 trial represents a major advance in breast cancer research with promising implications for other cancers and other diseases. Quintiles will make its grant in support of I-SPY 2 through QuantumLeap Healthcare Collaborative, a 501(c)(3) non-profit foundation and a co-project manager of the trial.
“Quintiles’ $2.6 million grant and our joining the I-SPY 2 management consortium reflect the company’s unwavering commitment to patients,” said Dennis Gillings, CBE, Quintiles Chairman and Chief Executive Officer. “Multi-party collaboration, adaptive trial design, biomarker use, and point-of-care data access are major steps in the right direction. Quintiles is proud to be part of this revolutionary effort.”
The Foundation for the National Institutes of Health is the sponsor of I-SPY 2 while the U.S. FDA, National Cancer Institute and 20 leading academic cancer centers are collaborators in the effort. Quintiles joins The Safeway Foundation, QuantumLeap Healthcare Collaborative, several biopharmaceutical companies, and individual donors as supporters.
FDA Finalizes Decentralized Clinical Trial Guidance
November 25th 2024The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Patient Engagement Platform Checklist
November 22nd 2024Modern clinical trials are more complex than ever, and one significant reason is the increased focus on patient engagement. Incorporating a patient engagement platform into your clinical trial enhances the patient experience and can lead to more successful trials with stronger, more reliable outcomes. We put together this helpful checklist of key features to look out for when choosing a platform for your study.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.
