NCI Trials Program Seeks Net Gains

The National Cancer Institute (NCI) plans to award as much as $160.5 million in fiscal year 2014 to support a large, multi-institutional network conducting late-phase clinical research through its new National Clinical Trials Network (NCTN). The NCTN will effectively replace the NCI-sponsored Clinical Trials Cooperative Group Program, which began in 1955.

Under the restructured system, the NCI will fund up to 5 clinical trials groups—up to 4 dedicated to studying cancer in adults and 1 to cancer in children—instead of the 10 American co-operative groups it previously supported.

As a result, several of the groups recently merged to form the Alliance for Clinical Trials in Oncology (formerly Cancer and Leukemia Group B, the American College of Surgeons Oncology Group, and the North Central Cancer Treatment Group); ECOG–ACRIN (once the Eastern Cooperative Oncology Group and the American College of Radiology's Imaging Network); and NRG Oncology (a combination of the National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, and Gynecologic Oncology Group). SWOG (formerly the Southwest Oncology Group) and the Children's Oncology Group remain unchanged.

In addition, the awards will help support core services, such as quality assurance for imaging and radiation therapy used in network trials and incorporating basic and translational science into NCTN research.

“We are fundamentally changing the program so it runs as a network,” says Margaret Mooney, MD, chief of the Clinical Investigations Branch in NCI's Division of Cancer Treatment and Diagnosis. “We hope that investigators will collaborate not only within their groups but also throughout the entire network. We want cross-fertilization between the groups.”

Plans for the NCTN developed in the wake of a 2010 Institute of Medicine report that pointed to numerous flaws in the Clinical Trials Cooperative Group System, such as its slow pace of initiating trials, difficulty in enrolling patients, and limited resources. To address those criticisms, Mooney says that the NCTN will standardize many processes by using a central patient registration system and a common data management system for collection of patient data, as well as provide support for the collection of tissue specimens.

A new reimbursement structure may make participation in clinical trials more feasible for institutions. Currently, cooperative group trials allot about $2,000 to cover costs associated with data collection for each patient enrolled in a clinical trial, which is less than the actual cost. Under the NCTN, centers that enroll a relatively large number of patients in trials will receive twice as much—about $4,000 per patient.

However, greater compensation is likely to mean that fewer trials can be performed annually, making it essential for the network to study the most important questions, says Mooney. Even so, she adds that having a more coordinated, collaborative, and efficient process will help speed critical discoveries to patients.