Every clinical trial aims to recruit and enroll the right participants who will stay engaged in the study from start to finish — but despite increased public awareness and interest in research participation, this is becoming more challenging than ever: More than 1 in 2 trials are canceled due to poor accrual, and 80 percent fail to enroll on time.
Very often, these problems stem from an undersized pipeline of potential participants. When site staff have to manually find patients for trials, or even when automated recruitment solutions don't deliver as promised, it puts the trial's viability at stake, with sites and sponsors in the hot seat.
If more trials made prescreening a fixed part of the study lifecycle in a way that optimized both personnel and technology, many of these problems might be avoided. But too often, comprehensive prescreening is overlooked in favor of more familiar, but also more outdated, manual tactics. Here's why that's a mistake — and why prescreening is the great missed opportunity for modern-day trial enrollment.
What is prescreening?
Prescreening activities take place at the outset of a trial, before informed consent. In this critical time, sites review the inclusion and exclusion criteria to determine a potential patient pool for the study. This information then gets reported to the sponsor so that they can assess enrollment feasibility.
Ultimately, sponsors and sites aim to start with as many prescreened patients as possible to maximize the participant pipeline. The trouble is, there are several different approaches to prescreening and no true standard.
"Typically, sites conduct prescreening manually through paper-based logs or printed spreadsheets that get emailed to sponsors," said Gillian Barron, Senior Project Manager at Advarra. "This outdated method leaves ample room for incomplete information, typos and other human errors that delay reporting and inevitably, delay enrollment."
As Barron adds, such manual workflows place too much expectation on overworked site staff with minimal optics for sponsors. But on the other hand, automated solutions place too much expectation on technology — without considering human capacity and strengths.
"You can't overlook the important role that site staff play in finding potential participants," Barron said. "They're the ones seeing patients, speaking to them on the phone and will be the first point of contact for patients who find the study through social media and/or recruitment websites. What they need isn't for their role to be replaced, but a solution that helps make that role easier and less cumbersome."
Finding the right balance between human and technology
Given the coexisting barriers and opportunities of prescreening, the optimal approach is to engage a platform that gives sites the tools they need for a more efficient process while also providing more transparency to sponsors.
Solutions like the prescreen navigator within Advarra's Longboat Platform is one example of a solution that does just that with a cloud-based, multi-device platform. Built to standardize the complexities of prescreening questionnaires, the Longboat Platform provides easy yes/no toggles for the most important eligibility criteria.
"Site staff can quickly go through the criteria, move the toggle to a yes or no, and submit the form," Barron said.
The completed form then gets presented in real-time to sponsors, who can see prescreening activity on a global, regional and site basis. Study teams can see where the patients are being found across each country and gain early insights into which of the inclusion or exclusion criteria are causing most prospective patients to fall out of the funnel. This removes the delays inherent in paper-based logs.
"It's so important for sponsors and study teams to have this information available to them in real-time," Barron said. "With that insight, they can more quickly identify trends, discover prescreening failures, monitor site performance and consider amendments to expand the participant pipeline — all at the very beginning of a study."
Already, the Longboat Platform's prescreen navigator has been deployed in more than 80 studies, effectively prescreening thousands of participants, many of whom go on to enroll and stay in the studies. In one case study exploring its application across four trials of a top-10 pharma company, the solution's efforts accounted for 94 percent of trial participants who eventually enrolled.
Boosting trial success with prescreening
As sponsors look to expand their participant pipeline, prescreening is an essential part of the clinical trial ecosystem. However, not all prescreening methods are effective. Failure to optimize this critical process can impact study timelines and ultimately, delay commercialization plans and treatment to patients.
Fortunately, there's a better way to do prescreening. With streamlined technology like the Longboat Platform's prescreen navigator, site staff can more easily do their jobs while getting back to what matters: their patients. In turn, sponsors can have the real-time insights they need to make decisions that affect the success of current and future research.