Faults seen in cancer study funding

It's well-known that clinical trials of cancer treatments often can't cover their costs. But a new study suggests that government-funded trials could take at least one cue from those backed by drug companies.

In 2010, the Institute of Medicine (IOM) released a report saying that the U.S. system for conducting cancer clinical trials was approaching a "state of crisis" (see Reuters story of April 10, 2010).

The IOM - an expert panel with federal support - said the National Cancer Institute's Clinical Trials Cooperative Group program was inefficient, bogged down by red tape and underfunded.

The NCI program includes a number of collaborative groups - academic cancer centers, researchers and community doctors that work together to conduct trials on cancer treatment. Altogether, the program involves more than 3,100 institutions in the U.S., Canada and Europe.

In the new study, researchers at one Canadian cancer center focused specifically on the timing of cancer clinical trial funding.

With cooperative group trials, funding typically comes as a "modest payment up front" for each patient enrolled, explained lead researcher Dr. Hsien-Yeang Seow of McMaster University and the Juravinski Cancer Center in Hamilton, Ontario.

Trials done by the drug industry, on the other hand, dole out money over time, as patients hit certain "milestones" - like during treatment, and as they come back for follow-up visits after treatment ends.

Seow's team looked at 97 clinical trials done at its center in recent years. Two-thirds of those studies were cooperative group trials, including some with NCI funding, while the rest were industry-sponsored.

Those included early- and late-stage trials of treatments for cancers including breast, lung and stomach cancer.

The researchers found that the cooperative group trials quickly began to lose money after the initial stages because the funds were all spent early on. That leaves nothing for study patients' follow-up, which can last for years.

The industry trials, in contrast, had more money going in than out at multiple time points - though any net income typically disappeared during longer term follow-up.

What's more, Seow's team found, its center had fallen into a pattern of starting new clinical trials in order to pay for patients' follow-up in the older, ongoing trials.

Seow likened it to a "Ponzi scheme" - albeit an unintentional and legal variant.

"In order to stay afloat," Seow explained in an interview, "we have to start new trials and recruit new patients."

The money from that new-patient accrual then goes to "pay down the deficit" of earlier trials. "Obviously, that's not sustainable," Seow said.

One way to help with the larger issue of sustaining cooperative group trials could be to switch from "up front" payment, according to Seow.