The National Cancer Institute selected Dartmouth-Hitchcock Medical Center as a lead academic participating site for a new network of clinical trials, which will allow its Norris Cotton Cancer Center to boost efficiency and improve trial completion rates.
Announced last week, Dartmouth will be one of 30 U.S. participants. The Norris Cotton Cancer Center is expected to enroll 74 patients annually into the program, called the National Clinical Trial Network, said principal investigator for the Norris Cotton Cancer Center site Konstantin Dragnev. If that goal is reached by the end of the year, he said, the center will be reimbursed for each patient.
Through the program, the institute will fully reimburse trial costs, said Robert Gerlach, the center’s associate director for administration and scientific affairs. In the past, the center had to request federal assistance for trial enrollment on a “milestone basis,” he said, with funds coming in as more subjects enrolled and data was submitted.
“As a lead academic participating site, NCI has contracted with us up front so it gives us a stable, steady stream of support to prepare and undertake studies and to activate them,” Gerlach said.
Federal funding, he said, does not usually cover the entire cost of clinical trials. The National Cancer Institute plans to reimburse network participants at a rate of about $4,000 per patient, an increase from the prior rate of about $2,000.
As a lead academic participating site, the Norris Cotton Cancer Center will be able to more effectively review clinical trial proposals, Gerlach said. The National Cancer Institute set up a new review system, called the Central Institutional Review Board, that allows sites to submit trial proposals to a panel of experts independent of the College.
“Our institutional committee may only see a couple of these studies each year out of the 100 that they are reviewing, but nationally the committee that’s been formed by the NCI has developed expertise in the particular area, which expedites the review,” Gerlach said. Dragnev said that, although the review process is independent, the College will be held responsible for the trials’ results.
Gerlach said the new system can approve clinical trials in two months, in contrast to the four months approvals previously took.
The grant spans all areas of adult oncology, but focuses on increasing efficiency and enhancing participation in Phase 3 clinical trials, Dragnev said.
“This year being the transitional year, we will focus on mostly completing trials that were designed two or three years ago in a more expeditious fashion,” he said. “At the same time designing trials that will utilize the system in a more rapid manner, such as trials in breast cancer and colon cancer as well as trials in non-small cell lung cancer.”
The old process required multiple steps to begin a clinical trial, Dragnev said, and by the time the trial had finished, scientific advances often made the question under review obsolete.
Gerlach said the center’s first trials under the new system will focus on blood cancer malignancies and gynecologic cancer.
The grant also enables the Norris Cotton Cancer Center to bring in new clinical trials from the 29 other institutions receiving National Cancer Institute grants, Gerlach said.
“A big advantage of this new system will be that the NCCC can offer patients the opportunity to enroll in new cutting-edge clinical studies that will eventually be brought to the center by the National Clinical Trials Network,” he said.
Norris Cotton Cancer Center interim deputy director Christopher Amos said that the College’s selection shows it has one of the country’s strongest cancer research centers. Patients will also be able to find and enroll in the center’s trials more easily, he said.
Gerlach said that the recognition will help the center attract enough patients to effectively hold Phase 3 trials, which require more patients to statistically show that new treatments are effective. These trials, according to the National Cancer Institute, are “the gold standard for establishing new treatments.”
The grant will last five years, Dragnev said, but will be renewed if the National Cancer Institute finds that sites are continuing to enroll patients.
