Optimal Just-in-Time Service Changing the Paradigm of Cancer Trials

In Clinical Studies News by Barbara Jacoby

From: businesswire.com

First-patient-in milestone achieved in only two weeks with Cancer Treatment Centers of America

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.

Deploying the Optimal JIT methodology at sites managed by CTCA®, a comprehensive cancer care network of hospitals, has significantly shortened site activation time from as long as eight months to as little as two weeks, allowing cancer patients to enter trials faster and enabling AES clients to reduce the time needed for study startup. Metrics generated by CTCA demonstrate results that surpass traditional sites on the same trials when evaluating data currency, query rates, deviations and retention.

“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. As a result of the efficiencies of this process, there are zero non-enrolling sites.

“Our partnership with Optimal is the latest example of how CTCA is developing best-in-class partnerships, combining 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,” said Maurie Markman, M.D., president of Medicine & Science at CTCA.

AES, which offers biopharmaceutical companies and contract research organizations best-in-class site conduct and patient access solutions, is able to use its unique Optimal JIT methodology to augment traditional enrollment efforts. In addition to enrolling the first patient within two weeks, 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.

About AES

Accelerated Enrollment Solutions is a business unit of PPD that offers sponsors and contract research organizations best-in-class site conduct and patient access solutions. These solutions are available as discrete services or integrated to provide a cohesive and highly differentiated trial acceleration strategy for insourced or outsourced clinical studies, all under results-based commercial terms. For more information, visit www.globalAES.com.

About PPD

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 48 countries and more than 21,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health. For more information, visit www.ppdi.com.

About Cancer Treatment Centers of America®

Cancer Treatment Centers of America Global, Inc. (CTCA) is a comprehensive cancer care network of hospitals and outpatient care centers in Atlanta, Chicago, Philadelphia, Phoenix and Tulsa. Specializing in the treatment of adult cancer patients, CTCA® offers an integrative approach to care that combines surgery, radiation, chemotherapy, and immunotherapy with advancements in precision cancer treatment and supportive therapies designed to manage side effects and enhance quality of life both during and after treatment. CTCA also offers qualified patients a range of clinical trials that may reveal new treatment options supported by scientific and investigational research. CTCA patient satisfaction scores consistently rank among the highest for all cancer care providers in the country. Visit cancercenter.com, Facebook.com/cancercenter or Twitter.com/cancercenter for more information.