Quintiles, the world’s largest provider of biopharmaceutical services, has introduced a new patient enrollment offering designed to accelerate study startup and reduce costs for oncology clinical trials by opening investigative sites for studies only after they have identified a qualified patient.
With the model, called Precision Enrollment, Quintiles has built a network of 80 oncology sites across the U.S. that can pre-identify patients based on study and biomarker criteria using electronic health records (EHRs) and other secondary data sources. Once a study volunteer has been identified, Quintiles can activate the site in less than 21 days, compared to the 155 days it typically takes to start up a site for a standard oncology clinical trial. This is because master service agreements are negotiated in advance and the sites have central Institutional Review Board (IRB) capabilities that streamline study startup.
“By opening a site only after a patient is identified, we’re able to expedite startup and reduce zero-enrolling sites and associated time and costs,” said Jeanne Hecht, senior vice president and global head, Site & Patient Networks at Quintiles. She noted that Tufts Center for the Study of Drug Development (CSDD) research has found that 11% of sites in multicenter studies fail to recruit a single patient and the cost of initiating each site has been estimated at $20,000 to $30,000.
Quintiles decided to focus its new rapid enrollment program on oncology studies because of significant challenges that have been faced when recruiting patients for cancer trials in the U.S. An increasing number of oncology drugs in clinical trials are targeted therapies, which are intended to treat niche patient populations, which makes finding participants that meet narrow eligibility requirements difficult. Conventional models for targeting these sub-populations and pre-screening patients are time- and cost-intensive, which makes it difficult for oncologists to match patients and studies.
“The goal is to shift the paradigm. The current model is somewhat broken and leads to cost overruns at sites and for pharmaceutical company customers,” said Hecht. “We’ve chosen oncology for a strategic reason based upon the importance of identifying the right patient at the right site and just how difficult of an indication it can be in relation to the protraction of recruitment rates.”
The Quintiles Precision Enrollment model represents a move from traditional enrollment methods that rely on opening a fixed number of investigative sites and then waiting until they can find patients that meet protocol requirements. Instead, the process gives sponsors access to patients across a large network, which can result in faster enrollment, without the cost and effort of opening each site.
“We are expanding our patient population for customers without adding any burden to the sites,” said Jeff Ventimiglia, a senior director in Quintiles’ Site & Patient Networks group and head of Precision Enrollment. “We are taking away a lot of the administrative work that goes into finding new patients. We want to create a much easier approach.”
Matthew B. Wiener, Pharm.D., president of Pharmatech, which offers both CRO and site management services, sees the potential for a wider industry adoption of the rapid site startup and enrollment model in indications that have small patient populations, such as neurology areas or rare diseases.
Wiener developed the Just-In-Time delivery model for oncology trials about 10 years ago, with support from the National Cancer Institute, which similarly requires research sites to pre-identify a patient, either through pre-screening or a patient registry, before they can be activated for a study. About 120 of the 250 sites Pharmatech manages in its network are capable of conducting Just-In-Time trials, with another 100 sites in development. Pharmatech has employed the model in about 50 clinical trials, where it has been shown to reduce costs and increase patient enrollment rates.
Although drug sponsors initially were reluctant to move away from the traditional site-centered enrollment model, Wiener said acceptance for Just-In-Time’s patient-centered approach, which brings clinical trials to treatment centers close to qualified patients, has grown in recent years as sponsor companies and CROs look for more effective ways to identify study volunteers and implement clinical trials.
“I have people from pharmaceutical companies coming to us now saying, ‘This is the way we have to do it,’” said Wiener.
Wiener said the rapid start-up process offers the highest value in indications that investigative sites typically have difficulty enrolling, such as clinical trials in rare disease areas or those that require genetic screening. On the other hand, in indications where there are large numbers of prospective patients and sites that can consistently enroll patients, such as asthma or diabetes, the Just-In-Time methodology offers less value. In addition, the model won’t work for a disease that needs to be treated immediately or when large numbers of potential study volunteers already can be identified through an established “center of excellence” for the indication.
The Just-In-Time or rapid start-up model works best, Wiener said, in community-based settings that can use a central IRB. Pharmatech’s Just-In-Time system, which pre-qualifies sites and has master contracts in place, can receive IRB approvalwithin 24 hours and activate sites in less than 10 days since the protocol, consent form and any other forward-facing materials have been approved by a central IRB in advance. By contrast, it can often take up to six months for academic research centers to get a project started because of the contracting, budgeting and IRB approval processes required.
Meanwhile, Quintiles, which has one project underway with its new model, plans to expand its Precision Enrollment program into new areas.
“We are focusing on the oncology studies because of how hard they are to recruit in the U.S., and looking at those rare, hard-to-find niche oncology patient populations. But we are going to look at ways and opportunities to apply this rapid enrollment program to other therapies and geographies in the future,” said Hecht. “It’s about disrupting the industry and shifting how we engage sites.”
This article was reprinted from Volume 20, Issue 22, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »