Just-in-Time Trials Can Save Time and Increase Diversity, Experts Say
Trials that identify prospective participants before activating a site can not only increase efficiency and reduce effort, they can enroll participants who are more reflective of actual disease populations, according to one group that intends to put this “just-in-time” (JIT) trial approach to the test in oncology.
At its heart, the JIT trial model — developed by research management organization Pharmatech a decade ago and now gaining in popularity — aims to improve patient access to trials and employ sites that have a high chance of enrolling participants. Instead of the traditional approach of activating a site and then waiting for it to find eligible participants, JIT trials require sites to pre-identify potential participants (by patient registry or by prescreening) before activation, enabling sponsors to select sites with the greatest capacity and potential for enrollment.
“JITs can accomplish in two weeks what many trial sites are unable to accomplish in two months,” wrote Kashyap Patel, president of the Community Oncology Alliance and CEO of South Carolina-based Carolina Blood and Cancer Care Associates, and colleagues in the journal Targeted Oncology.
“JIT trials can collapse and consolidate into days, and into six steps or less, a systematic process that begins first by fast-tracking patients identified from registry, confirming the eligibility of the patient and coordinating communications with the clinical team to rapidly assess and evaluate authorization for participation in the trial.”
This trial model has the potential to significantly accelerate the participant accrual process, democratize trial access and, most importantly for sponsors, reduce costs in oncology, Patel told CenterWatch Weekly.
“JIT allows a willing and able physician to identify a patient in the practice by doing appropriate molecular testing … and instead of opening a trial for a hundred mutations in one clinic, which could be labor intensive, cumbersome and most expensive for the industry, the trial could be opened when the patients are identified at the specific site,” he said.
Importantly for sites, JIT trials reduce considerably the amount of paperwork and ensuing labor that each trial activation requires, Patel and colleagues wrote in their article. And these models can take advantage of resources that may otherwise go unused in efforts to identify eligible patients and speed up site activation.
“JIT trials unlock opportunities hiding in plain sight, leveraging patient registries using real-world data and real-world evidence, patient-centered technologies coupled with standardized processes, remote support, centralized IRBs, and no redundancy,” they wrote. “JIT is about modernizing and changing the way sponsors think about and approach trials today.”
With precision medicine development on the rise, oncology has seen a shift away from the site of an individual’s cancer to the biology of the individual’s cancer and a more individualized approach. JIT trials could be especially useful for helping to bring greater diversity to trials of targeted therapies and precision medicines, Patel said.
But it’s not just oncology that may benefit from JITs; Patel believes that the model could be effective in any therapeutic area, particularly for trials of diseases with small patient populations, such as rare diseases and neurological conditions.
As more sponsors employ the JIT model, sites need to catch their attention and show they can be effective partners. Patel advises sites to post digital “resumes” on their websites to further cut down on paperwork and speed things up with sponsors. This should include trial experience; a list of all principal investigators; information on patient demographics; good clinical practice experience; certification with the Office of Human Research Protections; and other details sponsors would need to see to determine if the site is a good fit for their trials. Doing this can save both parties significant amounts of time.
“I get inquiries every day, and if I sit down and answer all the inquiries, I end up spending three hours a day for about 200 different sponsors at the end of the year,” he said. Posting on the website all of the information sponsors typically request in the site qualification process eliminates that effort. “One portal would allow sponsors to look at my site to see if I’m somebody they would want to work with. Then, as a patient is identified, the trial could be opened at our site with that specific patient.”
Due to the need for rapid site activation, Patel believes the model is probably at its best when it’s employed at community-based sites that use central IRBs, taking advantage of their ability for quick review and approval. Matthew Wiener, president of Pharmatech and one of the developers of the model, has also echoed this sentiment.
Patel and his team, along with eight to 10 East Coast research centers from Maryland to Florida, intend to launch a pilot testing out the JIT model and its impact on diversity in the next three-to-six months. As part of the No One Left Alone program, a project aimed at ultimately reducing cancer health disparities, they will look to see how JIT trials fare in increasing access to trials and biomarker testing that can help identify patients for targeted cancer therapies.