The new model, “Precision enrollment,” leverages secondary data, such as electronic health records, and the company’s investigative site network.
“The rise of precision medicine, coupled with increasingly complex trial protocols, is demanding innovative approaches to clinical trials,” Jeanne Hecht, senior vice president and global head, Site & Patient Networks at Quintiles, told us.
Currently, three out of five oncology treatments are targeted therapies with efficacy in niche patient subpopulations, which Hecht explained can contribute to higher screen failure rates and pose challenges for recruiting patients.
“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,” she explained.
The standard oncology site start-up takes an average of 155 days and Quintiles hopes to reduce this time by realigning the tradition site start-up pathway so that a site is only opened after a patient is identified.
“Once a patient is identified, our process is designed to open the study at that site within 21 days,” said Hecht, who added that the model helps connect more patients with a study specifically tailored for their situation.
And connecting patients with clinical trials is a ubiquitous problem in the industry. According to a report by Tufts, nearly 11% of sites never enroll a single patient and 37% under-enroll.
“More than $2 billion is spent annually on recruiting patients for clinical trials, and the cost to initiate a site is estimated at $20,000-30,000,” added Hecht.
However, even with significant investment, most consumers are still not aware of clinical trials. As Outsourcing-Pharma.com previously reported, significant education is needed to inform the general public about the existence of clinical trials.
The company has tested the new enrollment concept and is currently in the process of implementing it on an oncology study in the US participating in the Quintiles Precision Enrollment network.