Past Coverage Of Changes in
the NCI Clinical Trials System
Is the new National Clinical Trials Network set up for success or heading for failure?
The National Cancer Advisory Board Sept. 9 attempted to review the early signals coming from the institute’s revamped clinical trials system to determine whether it could use early tweaks.
The institute’s new network, configured to conduct new-generation “smart” trials of targeted agents, creates new mandates and capabilities, but—overall—it provides no new money to the clinical trials system.
|Partnership Points to New Path Forward For Drug Approval and Clinical Research|
SWOG earlier this week started to accrue patients to Lung-MAP, a clinical trial for second-line treatment of non-small cell lung cancer.
The trial, also called Lung Cancer Master Protocol or SWOG S1400, uses the patients’ tumor characteristics to select one of five targeted therapies, comparing them with active control in each arm.
Lung-MAP is funded by a public-private partnership, which combines NCI’s limited funds with those of commercial sponsors, pointing to a new way of pooling resources to conduct faster, more efficient registration trials.
By Peter C. Adamson
As funding issues surrounding the NCI’s new National Clinical Trials Network (NCTN) have been a prominent topic of recent news and discussions, to help inform the cancer research community, we are taking this opportunity to share data regarding NCTN funding to the Children’s Oncology Group (COG).
The COG was the recipient of three NCTN grants: a Network Operations Center grant, a Network Statistics & Data Center grant, and an Integrated Translational Science Center (ITSC) grant. Similar to other members of the NCTN, the funding support and restrictions on utilization of that support provided under the Network Operations Center grant created an unparalleled fiscal challenge for the COG.
|NCI-Funded Clinical Research In Jeopardy, Society Focuses on Value of NCTN Groups|
CHICAGO—The consequences of diminishing federal support for cancer research can be measured in the abstracts presented at the 50th annual meeting of the American Society of Clinical Oncology that concluded earlier this week.
To illustrate the impact of this drought, ASCO developed a graphic label to identify abstracts stemming from studies that had received U.S. federal funds.
|Over $20 Million Carved Out From Statistical, Operations Centers|
The budgets of operations and statistical centers of adult clinical trials groups were cut by about $20.4 million, group chairs say.
The cuts make it difficult for the groups to continue to support ongoing trials and raise questions about the prospects for starting a new generation of trials.
NCI officials say that, overall, the budget for the groups is staying flat, in part because some of the money is being channeled into 30 sites that received the Lead Academic Participating Site designation.
LAPS, which are run by cancer centers, will be allowed to charge more for putting patients on studies.
So where are the cuts?
NCI officials said they plan to hold a series of meetings with clinical trials group chairs and group financial officers in order to fine-tune the new National Clinical Trials Network.
“We are in the midst of one-on-one meetings with the group chairs and their financial people and their statistical leadership, [meeting] group-by-group [to] look at the numbers as they exist, and try to understand from both sides what that research budget will support and what it won’t support,” said James Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis.
“Without seeing, from the group perspective, what the resources can and can’t support, it’s hard to know from a system-wide perspective how we will move forward.”
In a telephone conference the institute convened to respond to concern from advocates, Doroshow said, in effect, that the budgets sent to the groups recently didn’t represent fait accompli, and that flexibility was an option.
|Varmus Pledges No Funding Gap for NCORP, Blames Snafu on “Unclear Communication”|
Following an explosion of criticism, NCI said funding for community oncology clinics would not be interrupted.
In “an open letter to the cancer community” April 10, NCI Director Harold Varmus assured researchers that funding for the NCI Community Clinical Oncology Program sites would continue as it morphs into the NCI Community Oncology Research Program.
|Group Chairs: Research in “Crisis”|
ASCO Says NCTN Budget Cut by 40 Percent,
Warns of “Dangerous Disruption of Cancer Care”
The chairs of the adult clinical trials groups that make up the NCI National Clinical Trials Network said in a letter that recent budget cuts have triggered a “crisis” in clinical research.
Simultaneously, a statement by the president of the American Society of Clinical Oncology, Clifford Hudis, amplified the concerns of the group chairs, and pointed to a separate problem in NCI’s transition to the new structure of clinical research: a three-month gap in funding for community oncology clinics engaged in institute-funded research.
|Groups Have No Budgets as NCTN Begins Work March 1|
Two years ago, NCI officials made a promise to increase the budget of the cooperative groups program by $25.6 million.
The boost, which was approved by the NCI Board of Scientific Advisors, was part of an effort to revamp the groups inspired by a report from the Institute of Medicine.
On March 1, as the cooperative group program officially becomes the NCI National Clinical Trials Network, new money will not be a part of the transformation.
|NCI Launches M-PACT Next-Generation Trial As Group System Nears March 1 Transition|
NCI has launched a pilot study to assess whether assigning cancer patients treatment based on the genetic characteristics of their disease can improve outcomes for patients with advanced metastatic solid tumors.
The Molecular Profiling based Assignment of Cancer Therapeutics, or M-PACT, trial is one of the first to use a randomized trial design to assign treatment based on specific mutations.