Save Cancer Trials From the NCI Slasher

Bruce D. Cheson, MD


April 16, 2014

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Hello again. This is Dr. Bruce Cheson from Georgetown University Hospital, the Lombardi Comprehensive Cancer Center, speaking to you for Medscape Hematology.

The assignment I have been given today is to answer the question, "If we could change one calcified feature of today's oncology culture, what would it be?"

I thought and I thought. I was given a list of possibilities, but it became even more crystallized during this past week. We need to change the relationship between the federal government and clinical research.

In the past week, as many of you may be aware, the National Cancer Institute (NCI) has decided to close the Community Clinical Oncology Program (CCOP) -- shut down their funding for at least 3 months as of June 1, jeopardizing care to patients who are managed in the community setting -- and to decrease funding for the National Clinical Trials Network (NCTN), which used to be cooperative groups and cancer centers, by 40%.[1,2] This will further strangle clinical trials, make it impossible to innovate, and make it difficult to complete trials that are already ongoing.

I have been in the cooperative group system since 1977. It's not perfect, and there is some waste and duplication. When I went to the NCI Cancer Therapy Evaluation Program (CTEP), there were about 23 cooperative groups. There is a cooperative group for darn near anything. There was a brain tumor study group, a Wilms tumor study group, and all these things. They were appropriately consolidated.

In all the years that I was there, the demeanor changed. It is becoming very evident. Initially we tried to work with the investigators. It was more of a collaborative effort. We'd meet with them, talk with them, go to the group meetings, and try to develop trials together that were in the best interest of science and patients.

Now it is a completely adversarial relationship, not only in the groups but in cancer centers as well. We try to get studies done, but they are sent back because of typos rather than being reviewed for the science. They are delayed for months and months for bureaucratic reasons rather than being evaluated for their science and saying, "Okay, in the next version, correct these." We see this over and over again. What they are doing to the cooperative group system is really too draconian.

Fortunately, we have positive relationships with the pharmaceutical industry. Then again, they have their issues and their agendas. It's not always easy to combine their drug with somebody else's drug to do the kind of study that you want to do, because it's not in their best interest in getting their drug marketed.

There has to be more collegiality, a more integrated approach to the clinical trials network. We can't have one organization basically destroying it when they're supposed to be nurturing it, watching it grow, and making it work better. Instead, quite the opposite is taking place. One thing that we certainly need to change is how the NCI impacts the clinical trial system.

The Institute of Medicine report[3] suggests that, yes, the groups are streamlined, but also, yes, the NCI put more money into the system to make it work better so that we can do more molecularly directed studies and more important types of trials. Those trials are being done, but the funding is no longer there. Clinical research will unquestionably suffer as a result of the NCI's decision.

This is Bruce Cheson, signing off for Medscape Hematology. Hopefully we will have a happier discussion next time.


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