Finding Patients Close to Home: A New Way of Recruiting for Clinical Trials
Beth Fand Incollingo
More opportunities to join clinical trials could soon be coming your way.
One company that helps pharmaceutical companies, academic institutions and governments around the world to plan, launch and run trials has come up with methods it believes will better help researchers and patients find each other.
That’s important to researchers investigating novel treatments, who routinely report that only about 5 percent of patients with cancer enroll in trials, a percentage they describe as being too small to sufficiently drive progress.
For their part, many living with cancer could benefit from the treatments tested in trials, but often are unaware of these opportunities.
PPD is one of many contract research organizations that support clinical trials, but it’s turning away from the “traditional methods” it says have resulted in 15 to 20 percent of participating trial sites never enrolling any patients and another 30 percent enrolling fewer patients than planned. This lack of participation can slow or end a trial.
“How can we think differently? We all want to reach more patients, and we need to do more to reach them in their communities, where they’re surrounded by the support systems they need in order to successfully complete treatment,” suggested Shannon Macquarrie, executive director for global project management for PPD. She spoke in a July 24 webinar, along with colleagues Rhonda Henry, PPD’s vice president of site networks and patient centricity, and Krystyna Kowalczyk, chief operating officer for optimal research.
The three, who focused their talk on cancer-related research, said that PPD has created a “just-in-time” approach designed to include more institutions, particularly at the community level, in trials, and make it easy for them to identify and recruit patients. This, in turn, will make the process more appealing to patients, they said.
“There’s a human aspect to that,” Kowalczyk said. “We want to talk about finding patients the treatments they need in the communities where they live, from physicians they trust, surrounded by the people they love.”
How It Works
The speakers noted that certain well-known cancer centers are highly sought by organizations planning trials, due to their success at enrolling participants. That breeds competition among the hosts of trials to work with those centers and enroll their patients, which is detrimental to the pace of research overall.
A key to the just-in-time strategy is the use of data to find, vet and partner with additional sites that are smaller and more local, but are also “research-savvy,” with patients to contribute and a successful history of completing trials.
“Eighty percent of patients are seen by local oncologists and centers,” Kowalczyk pointed out. By partnering with them, she said, “We have access to almost three-quarters of a million oncology patients every year who need alternatives, and many would consider a trial.”
PPD negotiates an infrastructure with sites of interest and then gives them the opportunity to prescreen their patients for a multitude of trials, run by different pharmaceutical companies, with the process treated as part of the standard of care. Eligibility criteria for trials that have specific drugs or doses in common — similar, but not competing, studies — are merged into a single description, so it’s easy for doctors to flag patients who might fit one trial or another. Labs that conduct genetic panel testing on patients or their tumors are included in the process and asked to contact physicians if someone is identified who might be eligible for a trial.
The institutions sign a general confidentiality agreement that allows them to assess patient eligibility for protocols, and PPD negotiates a contract agreement with them. All this leaves the sites ready at any time thereafter to start screening patients for trials brought to them by PPD.
When doctors refer patients to PPD who are found eligible for trials, the volunteers are onboarded in 14 calendar days — much more quickly than the traditional time frame, Kowalczyk said.
This swift timeline helps patients by enrolling them as soon as they meet eligibility requirements — for instance, immediately upon disease recurrence or the finding of a genetic biomarker, and potentially before the administration of other treatments that would prevent trial participation, she said.
Ultimately, the just-in-time system is designed to give patients more options, recruit them earlier, reduce the number of non-enrolling trial sites, control infrastructure costs due to the smaller hospitals participating, and bring drugs through development and to market about three months sooner, Kowalczyk said.
Responding to Challenges
Moving quickly is more important than ever, because the timeline for an oncology clinical trial has doubled over the past 10 years, Henry said. This is because trial protocols have become more complex, there are more endpoints — or trial goals — that can be used, and the criteria determining whether patients are eligible to participate have become more specific, particularly due to the growing use of drugs that target specific genetic biomarkers.
Competition for eligible patients can also extend timelines, the speakers said.
PPD intends to ease some of these crunches by analyzing data that includes facts about real-world conditions, as well as by communicating with doctors and patients and considering their feedback about how to make protocols better.
One way to use real-world data to set up a successful protocol, Henry said, is to compare proposed eligibility requirements to actual patient populations to make sure they are realistic. She added that it’s important for trial designs to incorporate patient feedback about barriers to enrollment, such as work schedules and patient concerns about side effects. For instance, this could include designing a trial to include wearable fitness trackers — with which many are already comfortable — to help participants track and report side effects, as well as considering how treatment schedules might impact patients who work.
Since patients with a cancer diagnosis often spend time researching their conditions on the Internet, Henry said, the use of virtual trials or virtual/on-site hybrid studies should be used to reach them and offer them more opportunities.
“We know there are patients out there willing to engage,” Kowalczyk said. “We simply need to find them and create the opportunity.”