By Kenneth Buck

June 23, 2016 | As clinical trials become more complex and zero in on narrower patient populations, time spent in site start-up is increasing. To address this growing problem and identify and enroll hard-to-find patients more quickly, Quintiles recently launched its Precision Enrollment program, which is designed to activate site start-up within 21 days of patient identification. The program is being rolled out first for oncology clinical trials.

To accelerate drug development, several drivers of clinical study cost need to be addressed, according to Jeanne Hecht, Senior VP and global head of Site & Patient Networks at Quintiles.  Hecht cites increasing trial complexity driven by pressures from regulatory compliance and audit readiness, reduced clinical reimbursement rates and a trend in studies designed to answer multiple questions.

“You add all of those together, and the paperwork in starting a trial and regulatory submissions process, and you run into big issues that are leading to delays in the system,” she said.

A trigger for site start-up

Two components of Quintiles Precision Enrollment introduce new sources of efficiency. The first component is aimed at eliminating administrative costs of unused sites. Citing a Tufts study, Hecht says, “we know that 11% of clinical research sites never enroll a single patient and 37% under-enroll. And if you think about the fact that more than $2 billion is spent every year on recruiting patients for clinical trials, and the cost to start up a site is between $20,000-$30,000, you can see there is a strong financial business case for the model.”

Traditionally, sites are identified first and taken through start-up, “and then you hope they can find a patient,” said Hecht. “So that means, to the site as well as to us and our pharmaceutical company sponsors, we’re taking a gamble.” Precision Enrollment delays site start-up until the first patient is ready, reducing this risk and inefficiency.

The second component is leveraging Infosario, Quintile’s informatics-based technology to identify patients that meet the inclusion criteria. This enables start-up to be activated only after patient identification, bypassing costs associated with start-up for non-enrolling sites.

Infosario gives clinicians access to specialized query tools that allow them to search electronic medical records to identify patient-protocol matches. The platform standardizes queries, allowing Infosario to perform searches at the site level rather than the system level. Following identification of matches, standard screening procedures are employed to ensure the patient is eligible.

Development of Precision Enrollment

The start-up trigger is also made possible through Quintiles’ Master Agreements with its network of study sites that cover multiple clinical studies. Currently, 83 sites in the United States are signed to the Precision Enrollment master agreements.

Hecht says that Quintiles spent well over a year developing the Precision Enrollment model. A stage-gate review was employed to evaluate the informatics, data sharing, regulatory, and business processes. While the business model was being honed, partner sites were recruited and taken through the contracting process.  

Hecht discussed the evaluation of clinical site capabilities. “We specifically modelled sites that we believe have a strong clinical practice … that have a very good background and foundational basis in performing clinical research studies. We were looking at catchment of patients and patient reach, but most importantly is the solid ability to execute on a clinical protocol with high quality and data fidelity,” she said.

Saving Time

Precision Enrollment and Quintiles’s combination of a committed network of partnerships, EMR informatics capabilities, and centralized institutional review process is projected to accelerate recruiting and cut off three months for a clinical trial.

Of course, this is dependent on meeting the 21-day benchmark for start-up, one of the more significant tests of the system. Hecht is confident. “We want to be there to support [the sites’] training, their resource needs,” she said, adding that the 21-day startup “was designed, piloted, and proven possible on a repeatable time…. That helps us accelerate getting the drug, the product to the patient as quickly as possible.”

Hecht noted that the program would have a role in larger Phase II and III trials in addition to Phase I studies. In the rollout, Precision Enrollment will target oncology patients, but Hecht added, “we’d like to eventually look at gastrointestinal disorders like Irritable Bowel Syndrome, Ulcerative Colitis, those hard-to-find patients and so we are evaluating that as potential next therapeutic areas.”