Clinical trials

By Jeff Raymond, Staff Writer

Published: April 28, 2008

Clinical trials are often a last resort for cancer patients — yet fewer than 5 percent of adults with the disease take part in them.

Clinical trials are how doctors and researchers ensure new treatments are safe and effective. They include drugs, medical devices and surgical procedures.

More than 60 percent of children with cancer participate in clinical trials. The smaller number of children with cancer and greater cooperation among pediatric cancer centers have boosted participation, doctors say.

Doctors say misconceptions about what will happen in the studies and lack of awareness contribute to the low participation.

“In general, these trials are the cutting edge of science and often allow patients at their particular point in time and disease history to get what’s currently available,” said Dr. Terence Herman, chairman of radiation oncology for OU Physicians.

Herman said the best care often is available in clinical trials, and patients are closely observed for the effects of whatever they’re given.

After researchers have studied a drug in cells and in animals in the laboratory, the Food and Drug Administration decides whether to grant approval for testing in people. This is a phase I clinical trial.

Because the drug’s appropriate dose and risks aren’t well known at this point, the trial will involve a relatively small number of people. Once these baselines are established, the trial moves to phase II, in which a larger group of people is studied to determine the drug’s effect on cancer and on the body as a whole.

Dr. Patrick Gaffney, an oncologist and researcher with the Oklahoma Medical Research Foundation, said those who participate in the first phase of clinical trials often are very ill.

“They’ll usually have failed just about every other option,” he said.

When trials advance to determining whether a new drug or device works as well or better than what’s currently used, researchers need a large number of patients.

Universities, research institutions and hospitals that conduct clinical trials have institutional review boards — groups of scientists and laypeople who ensure research is ethical and safe, and that patients are aware of what they are getting into and have given appropriate consent.

One misconception, according to the National Cancer Institute, involves use of placebos, which are sugar pills or other inactive substances. Placebos are almost never used in cancer clinical trials. And patients often chafe at being used as experimental “guinea pigs.”

“It’s not that patients are guinea pigs. I think they actually benefit from these trials,” Herman said, explaining that physicians wouldn’t subject patients to something without the possibility that they could benefit.

“These folks suffer greatly and we’re looking for ways to improve the outcome,” he said.

Moreover, he said he couldn’t think of a better way to conduct trials and the research they represent than the current method. More isn’t always better for drug doses, for example, and doctors can’t determine the appropriate amount to give patients without some trial and error.

One challenge for researchers is the variety of cancers and how they affect patients.

Herman is the principal investigator for clinical trials affiliated with radiation oncology.

The OU Cancer Institute treats more than 200 patients in clinical trials in a given year; most have gynecological cancers. These trials are through the national Gynecologic Oncology Group.

The cancer institute is the nonprofit group’s largest clinical trial site, Herman said, adding: “We take care of the bulk of the gynecological cancer patients in this community.”

Herman said there are three types of clinical trials — those that are at multiple sites, those that a scientist begins and those that a private company initiates.

“Usually there are small pilot trials involving new drugs or combinations of drugs and radiation,” he said of trials local researchers spur. He hopes greater interaction with local physicians leads to increased awareness of what trials are available.

Participants have the opportunity to help those who have the same cancer in the future.

Regardless of the source of the trial, the FDA must approve a drug or device to proceed for human testing.

Insurance coverage depends on the trial and the insurance company. A bill, called Stephanie’s Law, is under consideration in the Oklahoma Legislature to require insurance companies to cover routine medical care during clinical trials.Dr. William Meyer, a pediatric oncologist at The Jimmy Everest Center for Cancer and Blood Disorders in The Children’s Hospital at OU Medical Center, said almost one-third of his patients have leukemia. Meyer also holds a Children’s Medical Research Institute endowed chair in pediatric hematology/oncology.

In the 1960s, he said, “The diagnosis of leukemia was almost a death sentence.”

Now, the cure rate from a common form of childhood leukemia is greater than 80 percent, which Meyer attributes in part to better use of a combination of eight or nine medications that have been around for decades.

“When we say cure rates of 80 percent, we mean cure,” he said.

This has been possible because of what researchers have learned from the number of children who enroll in clinical trials and the cooperative studies among pediatric cancer centers.

“That is what has allowed us to make the advances that we have,” Meyer said.

Because pediatric cancer therapies are based on well-researched, multisite studies, the care available at participating institutions is similar, he said.

The Jimmy Everest Center enrolls the majority of children seen there in clinical trials.

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