Updated on 1 June 2016
Quintiles, the world's largest provider of product development and integrated healthcare services, has announced its Precision Enrollment offering.
The new enrollment model is designed to significantly accelerate site start-up and patient recruitment in oncology clinical trials working with the company's network of investigative sites across the US and leveraging secondary data (e.g. electronic health records-EHRs.) In this new model, the traditional site start-up pathway is realigned so a site is only opened after a patient is identified.
"The rise of precision medicine, scarcity of patients and investigators, combined with increasingly complex trial protocols, requires innovative approaches to clinical trial implementation," said Cynthia Verst, PharmD, President, Clinical Operations at Quintiles. "This solution harnesses Quintiles' deep therapeutic expertise in oncology, robust oncology investigator relationships and our demonstrated operational excellence to identify and recruit the right patient, from the right investigator, for the right oncology trial at the right time."
Today, three out of five oncology treatments are targeted therapies, with efficacy in niche patient subpopulations.1 These factors can contribute to higher screen failure rates and pose critical challenges for recruiting patients that fit a particular trial profile. Conventional models for targeting these sub-populations and pre-screening of these patients are time- and cost-intensive, making it difficult for oncologists to find the study that fits the individual patient.
With Precision Enrollment, Quintiles has built a network of oncology sites with master contracts as well as centralized IRB capabilities to streamline patient identification and start-up. The program will enable pre-identification of patients based on study and biomarker criteria, across broad geographic areas, using EHRs and other secondary data sources before a site joins a study.