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Desperately Seeking Pioneers For research Trials


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Lack of patients to test drugs hinders research


The Kansas City Star

JILL TOYOSHIBA | The Kansas City Star

At the Kansas City Cancer Center North, Bill Ruth of Kansas City, North, is receiving an experimental drug to treat colorectal cancer. Noel Bruce recently removed Ruth’s continuous infusion pump to connect one that will deliver saline.

You would think having about 400 new cancer drugs in the works would be totally good news.

But cancer researchers are getting worried. They’re rapidly running out of patients to test all these new drugs.

While cancer drug development is booming, the proportion of patients willing or able to take part in research has remained stuck for years at 5 percent to 10 percent.

That’s putting medical progress into jeopardy, researchers say. Some clinical trials of new drugs take much too long to complete or are simply cut short before enough data can be collected.

“There are more drugs flooding in, but you don’t have any more patients. The evaluation process is taking longer than it ever has,” said Richard Schilsky, a researcher at the University of Chicago. “Any time a new drug comes out, there’s a chance that an existing trial could be derailed.”

Cancer remains the second-biggest killer in the United States after heart disease. And cancer treatments, which can cost thousands of dollars a month, are a lucrative sector of the drug industry. Their sales were projected to more than double from 2004 to 2009.

But to sustain that drug development, more patients will be needed as research subjects.

When Jennifer Tam-McDevitt of the Geriatric Oncology Consortium in Baltimore ran the numbers, she found that the percentage of patients taking part in cancer clinical trials no longer will do.

For example, the 259 clinical trials last year for breast cancer drugs alone needed nearly 124,000 patients. That was equivalent to 58.7 percent of the breast cancer cases diagnosed in 2005, according to American Cancer Society estimates.

Clinical trials for prostate cancer drugs would require 20 percent of new patients, Tam-McDevitt found, and lung cancer drug trials 15 percent of the patients.

“No one has really looked at the number of patients needed relative to the number of patients we have,” Tam-McDevitt said. “What we’re trying to convey is 58.7 percent is a far cry from the 10 percent who were participating in trials.”

The pool of patients also is limited by the strict criteria of drug trials that may restrict participation based on a patient’s age, sex, stage of disease or previous treatment.

What may be needed is a national panel to decide which drug trials are most important and then to ration patients to them, Tam-McDevitt said.

But even more important may be a bigger push by cancer doctors to recruit more patients. Surveys show the vast majority of cancer patients learn about clinical trials from their doctors.

“We doctors have some degree of fault. Physicians are becoming busier, and putting patients on a clinical trial takes a lot of work,” said Robert Pluenneke, a physician with the Kansas City Cancer Center.

Some doctors are reluctant to get involved in clinical trials because they involve lots of paperwork and regulations and support staff.

Pluenneke is in a large citywide cancer practice that participates in about 130 cancer drug trials. He has two full-time research nurses and a data manager at his disposal.

But doctors in smaller practices often lack these resources. Reimbursement by drug trial sponsors, typically pharmaceutical companies or the federal government, often runs well below the $4,000 to $6,000 cost of seeing a patient through a study.

Doctors also must be willing to dedicate time persuading reluctant patients to participate.

Like many patients, Bill Ruth hesitated when offered a chance to join a drug trial through the Kansas City Cancer Center.

The 48-year-old Kansas City jeweler and metalsmith was diagnosed in March with advanced colorectal cancer.

“I was tempted to say no,” Ruth said. “There were so many decisions, so many things to deal with. I’d never heard of clinical trials before. The first thing out of my mouth was placebo and guinea pig.”

Those are common misconceptions, Pluenneke said.

Studies show that cancer patients who join clinical trials generally do at least as well or even better than those who don’t, he said.

Clinical trial patients often get more attention from doctors. And they tend to get higher doses of chemotherapy.

And getting a placebo in a cancer trial doesn’t mean treatment is limited to a sugar pill.

Most clinical trials compare new drugs to current “gold standard” treatments. Patients who receive a placebo instead of an experimental drug typically get standard cancer treatment also.

But uncertainty about which treatment a patient will receive can make some clinical trials hard to sell, Pluenneke said.

“That bit of the unknown is a difficult thing for patients to encounter at that time of their life,” he said. “Just not knowing what they get makes patients shy away.”

After giving the option of a clinical trial more thought, Ruth decided to take part.

“I trusted the doctor, but I also thought it was an advantage I could take,” he said. “And there was also altruism to it, if someone could benefit without it affecting my treatment.”

Researchers have reason to hope that if more cancer patients learn the facts about clinical trials, more will volunteer.

The Coalition of Cancer Cooperative Groups, a nonprofit organization promoting participation in clinical trials, recently surveyed cancer survivors. It found that only about 10 percent knew during their treatment that clinical trials were available. But among patients who did know about the trials, 40 percent tried to enroll.

“If we could raise the awareness level, we could raise the participation level,” coalition president Robert Comis said. “It really boils down to that point of contact between patients and doctors.”



Clinical trials Q&A

What are cancer clinical trials?

Clinical trials are research studies to find better ways to treat cancer. The trials often compare the most accepted cancer treatment to a new treatment that doctors hope will be better. Each study has rules about who can participate based on such factors as age, sex or type of cancer.

What kind of information will I receive before joining a clinical trial?

A doctor, nurse or other research team member will explain why the study is being done and what will happen during the study. Participants receive a consent form explaining each step of the study, possible side effects and how the study may affect daily life. Even after signing the consent form, participants still can leave the study at any time.

Who ensures my rights are protected?

Groups of experts at the national and local levels approve studies before they begin. One of the most important local groups is the research organization’s institutional review board. The board, which includes doctors, nurses and community members, reviews studies and makes sure they are run safely and fairly.


To reach Alan Bavley, call (816) 234-4858 or send e-mail to abavley@kcstar.com. | Source: National Cancer Institute

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