The National Clinical Trials Network Continues to Survive—and Thrive
Thursday, Dec. 03, 2015
Despite what appear to be countless challenges to its existence, the National Clinical Trials Network (NCTN), continues to thrive as it attempts to improve treatment for the 1.6 million Americans diagnosed with cancer every year.
That was one of the messages of Wednesday's Annual Oration in Radiation Oncology by Walter J. Curran Jr., M.D., executive director of the Winship Cancer Institute of Emory University, and the Lawrence W. Davis Professor and Chair of Emory's Department of Radiation Oncology.
In his talk, "NRG Oncology and the National Cancer Institute's National Clinical Trials Network: A Case Study for Innovation in Multi-Disciplinary Cancer Research," Dr. Curran made a comparison between the NCTN and the lowly cockroach.
"Both the cockroach and the NCTN survive—and even thrive despite a multibillion dollar industry fighting its existence, and despite the fact that there are new antidotes to its existence every year, and despite its lowly status in its domain," Dr. Curran said.
The NCTN was formed just two years ago when NCI's previous national clinical trials program—the Cooperative Groups—was reorganized.
"These cooperative groups, despite the enthusiasm for them, were not a high priority for several National Cancer Institute directors," Dr. Curran said. "And that paved the way for some transformation."
Back in 2010 the Institute of Medicine (IOM) took a look at the groups and asked some questions about their future. For example, Dr. Curran said, there were questions about whether these groups should even be continued because of the amount of private research activity being done by entities such as pharmaceutical companies.
Arguments for keeping the system, Dr. Curran said, included the fact that it was cost effective—it cost only about $150 million a year.
And a publicly supported network of research helps the radiology oncology community in other ways, such as getting newly approved agents integrated into standard regimens.
"The pharmaceutical industry will often study an agent in order to get FDA approval, but there may or may not be an appetite for that company to then look at how it is integrated into a standard regimen with chemotherapy, radiation, and surgery for other stages of other disease," he said. "The groups have been very good at that."
Additionally, this kind of system provides opportunities for multi-modality trials testing surgery, radiation and imaging—something, Dr. Curran said, industry would be less likely to support. These groups provide avenues for researching therapies on less common cancers.
The IOM report found that while the groups were doing
some critical work, changes were necessary, particularly in terms of getting trials from the concept stage to activation.
As a result the National Cancer Institute consolidated the nine groups that conducted clinical trials on adult cancer patients into four groups.
The new system—the NCTN— consists of four adult groups—the Alliance for Clinical Trials in Oncology, the ECOG-ACRIN Cancer Research Group, NRG Oncology, and SWOG—as well as the Children's Oncology Group.
One of the major gains with the new system is that it is more timely and efficient, Dr. Curran said. One drawback, though, is that the NCTN budget is less than what was hoped for and that the number of patients enrolled in trials has dropped, as have the number of trials.
Dr. Curran also argued that decreasing the number of groups runs the risk of reducing the participation of certain stakeholders such as surgeons and radiologists.
NCTN Continues Cutting-Edge Research
Yet, despite these challenges, the NCTN is involved in some exciting work, he said, referring to a series of trials showing that "the genomic variability among tumors is being ascertained early on and is determining what therapies will be tested for a patient."
One such trial is NCI-MATCH (Molecular Analysis for Therapy Choice) analyzes patients' tumors to determine whether they contain genetic abnormalities for which a targeted drug exists, and assigns treatment based on the abnormality.
This trial has created so much interest within the oncology community that it is expected it will complete enrollment of 3,000 patients in 2016.
Returning to the cockroach-NCTN analogy, the "reality is there is no alternative [to the NCTN] in its niche," Dr. Curran said. "And natural history, for both of these entities, will celebrate their success."