Contact: Brian Vastag
NCI Press Office
Phase III clinical trials large studies conducted after a drug or treatment has passed preliminary testing are the most reliable way to improve cancer treatment. But relatively few patients have the chance to participate in these studies. A primary reason is that, traditionally, only physicians who are members of NCI Cooperative Groups have had the opportunity to place patients on large-scale cancer clinical trials.
The Cooperative Group system, which was established in 1955, enrolls some 20,000 patients in NCI-supported multi-institutional clinical trials each year. Together, the 12 Groups receive over $140 million in annual funding from NCI, conduct several hundred clinical trials among their component institutions at any given time, and are the cornerstone of the nation's clinical cancer research.
The EPP complements this system by extending clinical trials privileges to other qualified oncologists, offering them a menu of important studies with simplified administration and direct reimbursement for the additional time and effort involved in enrolling patients and collecting research data.
"Cooperative Groups have contributed enormously to cancer research. Unfortunately, 97 percent of U.S. cancer patients still never participate in a clinical study," said
Richard S. Ungerleider, M.D., EPP project officer and chief of NCI's Clinical Investigations Branch. "The reason is that real or perceived barriers prevent widespread physician participation in Cooperative Groups."
A major impediment is that Group members can only enroll patients in studies supported by their own Group. The EPP, on the other hand, lets physicians enroll patients in a range NCI-sponsored Group studies. This means that EPP physician partners and their patients have a wide choice of treatment studies.
Sixteen clinical studies for the four most common cancers breast, lung, prostate, and colorectal are currently open to EPP physician partners, with more available later this year. (Each of these studies is still open to its originating Cooperative Group, which will analyze and publish the results.)
Another obstacle, the paperwork and procedures typically required for each study participant, is lessened by the EPP's Internet-based data entry system. Patient information and study data can be entered directly from physicians' computers, reducing time spent on paperwork.
Because caring for patients in clinical studies requires additional time and effort by the physician and staff, EPP partners, are provided $1,500 per patient to cover research-related costs.
"Many times a physician who would like to put a patient on a clinical trial hesitates because he or she receives no reimbursement for the time spent on these activities," says Scott Saxman, M.D., senior investigator in NCI's Clinical Investigations Branch. "The EPP is a way of encouraging them to spend the extra time it takes while letting them know that they're doing something valuable."
The EPP is pilot testing what will become a national network of physicians with access to NCI-sponsored clinical trials. Once under way, this network will allow any oncologist whether working in a large academic hospital or small community clinic to enroll for patients in Cooperative Group studies via an Internet-based system. By granting wider access to clinical trials, the network should reduce the time it typically takes each Phase III study to accrue the hundreds or thousands of necessary patients.
"Trimming the amount of time it takes to complete these studies will speed answers to important treatment questions and quicken advances in cancer care," said Ungerleider.
The EPP is one component of a large-scale plan to restructure and strengthen the NCI clinical trials system. So far, 12 organizations have joined EPP, including small private practices and large HMOs (see full list below). More information is available from the NCI Press Office, or from the Web sites listed below.
EPP Physician Partners
APN/Impath Research Co., LLC (Fort Lee, N.J.)
Cancer Research for the Ozarks (Springfield, Mo.)
Coastal Cancer Center (Myrtle Beach, S.C.)
Green Mountain Oncology Group (Bennington, Vt.)
Hematology & Oncology Associates of Eastern Idaho, PLLC (Idaho Falls, Idaho)
Howard University/PCM (Washington, D.C.)
Kaiser-Permanente Mid-Atlantic (Kensington, Md.)
Kaiser-Permanente of Northern California (Vallejo, Calif.)
Montgomery & Warmuth M.D., P.A. (St. Augustine, Fla.)
North Idaho Cancer Center (Coeur d'Alene, Idaho)
North Country Oncology/Hematology (Glen Falls, N.Y.)
VA Medical Center (Buffalo, N.Y.)
More information on the Web:
EPP Web site
Overview of NCI's clinical trials restructuring
History of NCI's Cooperative Group Program
NCI's CancerNet Web site (general cancer information)
For more information about cancer, visit NCI's Web site for patients, public, and the mass media at http://www.cancer.gov.