Trying to outsmart cancer

“Today’s standard cancer treatments were yesterday’s clinical trials.” That’s a mantra at the National Cancer Institute (NCI), and it shapes the commitment to research at local hospitals as well. Both Enloe Medical Center and Feather River Hospital in Paradise participate in clinical trials, benefiting not only the patients in their cancer centers but also, potentially, patients around the world.

“It’s not done [by the hospital] to make money,” said Elise Hale, clinical-trials coordinator at Feather River. “It’s in place here in order to offer our patients a broad scope of possible treatments.”

Treatments that, in many cases, wouldn’t have come about without clinical trials.

Advances in medicine have to start somewhere. Ideas that work in a lab may not translate into successful treatments, so scientists and physicians need to test experimental drugs and radiation regimens. Universities provide substantial opportunities for research, but since teaching hospitals treat only a small fraction of all cancer patients, community hospitals increase the scope and scientific validity of medical studies.

Feather River currently has seven clinical trials open to patients and another that’s ongoing. Enloe has 12 open trials—and, thanks to a decision reached just last week, soon will double, triple and perhaps quadruple that number.

Enloe has signed on to a pilot program through the NCI called the Central IRB Initiative (IRB stands for Institutional Review Board). The federal government requires every hospital that conducts research to maintain an IRB overseeing its clinical trials. Monitoring requires significant time and paperwork.

Centralizing documentation and related functions into a single IRB can reduce a hospital’s manpower and financial needs. Dr. Michael Baird, executive director of the Enloe Regional Cancer Center, estimates the savings at up to 75 percent, which would enable Enloe to offer many more trials for what it spends on the current dozen.

How that idea translates into the real world remains to be seen, which is why the NCI is giving the centralized IRB a test run—a clinical trial for clinical trials. Enloe is one of just 25 hospitals nationwide participating in the pilot.

Within two months, Baird said, Enloe should be able to open another dozen trials, and the number should grow: “Instead of struggling to have 10 studies open for two patients, we anticipate we’ll have 40 to 50 studies open. We can have a wide net open.

“Once this happens on a national level,” Baird added, “it will make access to clinical trials that much broader.”

Enloe and Feather River both have affiliations with leading universities: Enloe with the University of California, San Francisco; Feather River with Stanford University. Each local hospital also participates in clinical trials from other institutions, through a research cooperative. In many cases, the patient needn’t travel to the university hospital—local doctors can oversee most treatment and testing.

Clinical trials generally cover a wide range of conditions. Community hospitals need to determine which studies are worth the effort and expense before their physicians and patients participate.

At Enloe, oncologists in the cancer center recommend new trials they feel have merit. If the medical staff and administration agree, the proposal goes to the IRB, which meets every other month. Only with the approval of the IRB can Enloe open a trial.

The process is similar at Feather River, where Dr. Sam Mazj, medical director of the cancer center, puts forth recommendations that the IRB considers at quarterly meetings.

Once a clinical trial is open, physicians can refer patients who meet the study’s criteria. Those patients may receive additional examinations and lab work along with the experimental treatment. There’s no guarantee it will work—in fact, Baird says, few clinical trials yield cures—but for patients not responding to conventional radiation or medication, a breakthrough therapy can represent hope.

“There’s a common belief that ‘new is better’—and sometimes it is,” Baird said.

Sometimes it’s not. Unproven treatments may trigger side effects; thus, the need for clinical trials. When a participant at one hospital exhibits a side effect, the news goes out to the other hospitals, where each IRB assesses the significance.

Local IRBs comprise more than just doctors. Feather River, for instance, has a chaplain and a social worker on its 11-person panel. The IRB not only considers scientific aspects of a study but also its moral implications.

The downside, of course, is that people without medical degrees get to vote on medical matters. The centralized IRB comprises scientists—“experts in the field,” Baird says—who regularly review all reports of complications and decide whether a side effect is serious enough to notify local IRBs.

As of now, Feather River is not inclined to affiliate with a central IRB, Hale said—“Our institution wants our hand in [monitoring clinical trials] as much as possible. I imagine if circumstances change, that could change.”

Enloe’s IRB voted last Wednesday (Aug. 17) to join the Central IRB Initiative. Baird explained that Enloe will retain control of its clinical trials while expediting the process of administering them.

“Eventually, every hospital in the country will be part of this program,” Baird predicted—and, with Enloe helping shape the centralized-IRB concept, “we’ll be able to influence national policy.”