Patients lacking for drug trials Shortage of volunteers to test new therapies hampers cancer studies

Recruiting a struggle

May 31, 1998|By Jonathan Bor and Diana Sugg | Jonathan Bor and Diana Sugg,SUN STAFF

Despite a sudden wave of progress in cancer research, scientists say their efforts are often slowed by struggles to recruit patients for the experiments that ultimately show whether new therapies are winners or duds.

It's the flip side of an encouraging story that captured the public attention in recent weeks.

Decades of slow, laborious study have led to new ways of preventing or treating the nation's second-leading killer disease. In the past month, scientists have reported success in preventing breast cancer with the drugs tamoxifen and raloxifene, shrinking advanced tumors with herceptin and treating early cancers with taxol.

What the public doesn't perceive, however, is that many trials go begging for volunteers. While the recent news prompted many cancer patients to ask their doctors about the drugs, researchers don't expect to have an easier time recruiting people for new studies.

Those involved in the tamoxifen trial said the slow pace of recruitment was one factor, though not the only one, that caused it to take five years rather than the two to complete.

"I talked to women's associations, gave talks at night, talks in the daytime, went to every hospital and every clinical center," said Dr. George Elias, a Baltimore cancer surgeon who ran the study locally. "I advertised the trial, put it in magazines, talked to the old women, talked to the young women -- and all I got were 75 people throughout the state of Maryland."

Ultimately, the trial attracted 13,000 from the United States and Canada. The results were so impressive -- a 45 percent reduction in cancer risk -- that researchers decided they didn't need to meet their original target of 16,000 women.

Researchers' problems

Elias, who works for the Helix Health System, started enrolling volunteers at his former post at the University of Maryland Medical Center, said he encountered problems that many researchers face.

Private doctors didn't want to recommend a drug that might not work. Some patients were scared by reports that the drug could increase their risk of uterine cancer; others were eager to get the drug, but bowed out when they learned they might get a placebo instead.

Of the 7 million Americans who have been diagnosed with cancer in the past five years, only 3 percent have participated in clinical trials. Researchers say progress would come faster if more people enrolled, but recognize that many patients turn away because they fear becoming a guinea pig in a scientific experiment that might not help them.

Experimental vs. better

Dr. David Golde, physician-in-chief of Memorial Sloan-Kettering Cancer Center, says doctors should be honest enough to explain the limitations of clinical trials. The public, he said, is often misled into thinking that "experimental" means "better." In the end, most progress is incremental. Many treatments fail, and others trade a few months of survival for harsh side effects.

"These are toxic, unproven drugs that are being tried, and many of them don't work," Golde said.

In the end, a drug must prove its value in a head-to-head contest with standard treatment. Many patients are desperate to try an experimental drug, but reject the idea that a virtual coin toss will determine whether they get a new drug or standard therapy that may not offer much hope.

Patients' misconceptions

This very problem has delayed progress of three experiments aimed at showing whether bone marrow transplants can extend the lives of breast cancer patients. Doctors in the federally funded trial just finished recruiting several hundred people for the trials. But the process took eight years -- twice the time originally planned.

"Many doctors and patients believed that bone marrow transplants were the right way to go, and they didn't want to be randomized in a trial where half got it and half didn't," said Dr. Nancy Davidson, who heads breast research at the Johns Hopkins Oncology Center.

Not wanting to leave anything to chance, many women learned they could get the transplants by "going outside the study." This means they got treated at medical centers that already offered the transplants for leukemia, lymphoma and some other conditions, and more recently treated breast cancer patients as well.

Many patients mistakenly believe that entering a trial means they risk forgoing treatment, according to researchers. Placebos are commonly used in trials involving healthy patients, such as the recent tamoxifen study. In studies of sick patients, however, new drugs are usually measured against standard therapy. In a typical experiment, one group might get traditional chemotherapy while the other would get the chemotherapy plus something else.

"So much of what goes on in clinical trials is in fact just routine care that would have gone on anyway," said Dr. Allen S. Lichter, president of the American Society of Clinical Oncology. But many patients don't understand that.

Another problem has been the refusal of insurance companies to pay medical costs associated with treatment.

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