Optimal Just-in-Time Approach Accelerates Enrollment in Trials

Using an approach called Optimal Just-in-Time (JIT) has shortened the start of patient enrollment in clinical trials of both solid tumors and blood cancers from eight months to only two weeks.

Among other advantages, the methodology also enabled the recruitment of more diverse patient populations than traditional approaches.

Optimal JIT works by establishing a network with pre-negotiated contracts and terms for immediate engagement to search for trial participants. Illustrating the methods’ efficiency, all sites using Optimal JIT — managed by Cancer Treatment Centers of America (CTCA) — were able to enroll patients, which could represent a solution to the current 40% of trials that stop early because of poor enrollment. Also, all identified patients were randomized into a study.

“Our collaboration with CTCA demonstrates how we are changing the paradigm of cancer care,” Krystyna Kowalczyk, chief operating officer for Optimal service offerings, said in a press release. “Together, we are creating meaningful opportunities for cancer patients to participate in clinical trials and access innovative therapies close to home, allowing them to receive care within the context of their support networks in their own communities.”

Kowalczyk added, “Our goal is to enroll more patients from fewer sites in less time to support important oncology trials. Thanks to our JIT methodology, a two-week turnaround for first-patient-in is now possible.” According to the team, this helps ease patient and caregiver anxiety.

“JIT studies are a game changer for clinical research and open up a new horizon to improve recruitment in trials,” said Alan Tan, a principal investigator of several trials within the CTCA network.

“The on-demand approach offers patients rapid access to high-impact trials that can reassure potential patients that they will be taken care of in a timely manner and not left in a holding pattern,” he added.

Kowalczyk further noted that about 30% of the patients enrolled within the CTCA, a cancer care network of hospitals, are from under-represented populations — women, Hispanics, Alaskan Natives, and African-Americans — reflecting Optimal’s aim to expand opportunities for patients less likely to be recruited.

In turn, Maurie Markman, MD, CTCA’s president of medicine and science, said the collaboration with Optimal is one of the “best-in-class partnerships” that combine “cutting-edge research and treatments with our Mother Standard of Care to rapidly implement a novel clinical trials strategy that enhances our already superior care model to serve our patients.”

Besides the speedier start of enrollment, Optimal JIT, a service of PPD’s Accelerated Enrollment Solutions (AES) business unit, also cut operations costs from $31,998 with traditional methods to $14,548.

According to the team, the methodology is ideal for trials in rare tumors, as the studies are not open until a patient has been identified.