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Applied Clinical Trials
Optimal Just-in-Time, a service of PPD’s Accelerated Enrollment Solutions (AES) business unit, and Cancer Treatment Centers of America (CTCA) are collaborating to speed patient enrollment in oncology clinical trials, enhancing patient access to potentially life-changing therapies and saving time in drug researchers’ quest to conquer cancer.
“Our collaboration with CTCA demonstrates how we are changing the paradigm of cancer care,” says Krystyna Kowalczyk, chief operating officer for Optimal service offerings. “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. Some 30 percent of the patients we enroll with CTCA are from under-represented populations, which reflects our goal of expanding clinical trial opportunities more broadly. 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.”
The JIT approach is based on establishing a community of sites with prenegotiated contracts and terms, which provides immediate engagement by sites to search for patients. Patients are identified first, triggering the activation of sites, enabling patients to be enrolled within two weeks.
AES, which offers biopharmaceutical companies and contract research organizations patient access solutions, is able to use its Optimal JIT methodology to augment traditional enrollment efforts. In addition to enrolling the first patient, Optimal JIT’s enhanced enrollment practices provide clients with a diverse geographic distribution and a varied patient population using prequalified sites and patients to support the ongoing needs of the study.
The collaboration is particularly significant at a time when seeking patients for oncology trials represents a unique challenge for pharmaceutical and biotech companies. Enrolling patients for oncology research sites can take as long as eight months from protocol outreach to site activation. Studies show that 40 percent of current ongoing trials will not meet their enrollment targets, while as many as 60 percent of sites never enroll a single patient.