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Clinical Trials for Cancer Running Out of Volunteers
by: E.J. Mundell

What if you organized an important cancer clinical trial and nobody came?

That scenario could become a reality for oncology researchers across the United States, new research shows.

Some experts are even advocating that the small pool of informed, willing study participants be rationed to only the most important cancer trials -- leaving other studies to languish or close down.

It's a notion that saddens 38-year-old cancer survivor Rod Quiros, who contracted a potentially deadly lymphoma when he was only 23 but made the decision to enroll in an experimental drug trial.

"I don't think I'd be here to tell my story if I had not participated then," he said.

"We really can't do enough to stress how important trials are," said Quiros, a business analyst who lives in Suffern, N.Y. "We may have a wonder drug sitting in a dark freezer somewhere, but if you can't get enough people to participate in the trials and help advance that, we'll never find out if it works."

Experts say that, for the past few decades, just 5 percent to 10 percent of all cancer patients in the United States have joined a clinical trial. But with the current boom in biotechnology and drug development, the demand for willing, eligible study participants now far outstrips the supply.

In a study reported recently at the annual meeting of the American Society of Clinical Oncology (ASCO), Jennifer Tam-McDevitt and colleagues at the Baltimore-based Geriatric Oncology Consortium tallied up the number of participants needed to complete all 679 active phase I, II and III clinical trials for breast, lung and prostate cancers in the United States.

According to Tam-McDevitt, the nearly 238,000 patients needed to fulfill enrollment and complete these studies "would represent more than half of the total 2005 [cancer] incidence." That's a far cry from the less than 10 percent of cancer patients currently enrolled in U.S. trials, she said.

"Within certain tumors and certain cancers, we really are running out of patients," warned Tam-McDevitt, who is director of scientific development at the consortium.

Why the shortfall? It's certainly not because patients are unwilling to join up, said Dr. Robert Comis, president of the Coalition of Cancer Cooperative Groups (CCCG), which lobbies to increase patient and doctor participation in trials.

His group published its own study at the ASCO meeting. It found that, when informed about a clinical trial by their doctor, 40 percent of cancer patients either enrolled or tried to enroll.

Of those people who did meet eligibility requirements and participated, 96 percent said they "were treated with dignity and respect" during the trial, and 91 percent said they'd recommend participation to a family member or friend with cancer.

Still, the experts said, some cancer patients do misunderstand clinical trials, worrying that they'll be given a placebo "sugar pill" instead of active treatment. That's never the case, however, since these studies typically compare a newer intervention against the current "gold standard" of care available for their disease.

In fact, clinical trials are usually so well-constructed that patients tend to get better care than they would outside the trial setting, experts said. "My treatment was just as good or better than if I was in a regular protocol," said Quiros, who's been cancer-free for several years. "There was a lot of attention and follow-up," he said.

So, why aren't more patients getting that message? The experts agreed that the real roadblock occurs in the doctor's office.

"In the vast majority of cases, the deciding factor for the [participating] patient was that their doctor had recommended they go on the trial," said Dr. Richard L. Schilsky, chairman of ASCO's Cancer Research Committee. "However, what you find is that about 70 percent of patients who are enrolled are enrolled by just 30 percent of participating doctors."

In fact, in the Coalition of Cancer Cooperative Groups' study, Comis' team found that only 10 percent of the nearly 1,800 cancer survivors interviewed said their doctor had mentioned a clinical trial.

According to the experts, oncologists may be reluctant to suggest trials for a variety of reasons.

"Being treated on a protocol makes more demands on patients and doctors than being treated by routine medical care," Schilsky said. Tests are performed more frequently, for example, and must be done at specific times.

Treating a patient through a clinical trial usually means higher costs for the doctor's practice, too. Enrolling a patient in publicly funded trials, especially, can cost doctors money.

"Typically, the government will reimburse about $2,000 per patient," Schilsky said, "even though we know that it actually costs about a minimum of $4,000 to $6,000 to support the infrastructure that's required to enroll patients in clinical trials."

Clinical trials are also heavily burdened with regulation and paperwork. And some doctors worry about litigation, especially for trials focusing on experimental agents.

"When you put all these things together, it explains why only a small proportion of oncologists are actively engaged in clinical trials," Schilsky said. Action at the federal level to ease these barriers could boost doctors' willingness to suggest clinical trials to patients, the experts said.

In the meantime, more drastic measures are being discussed. Tam-McDevitt said her group, which lobbies for more cancer research aimed at elderly patients, is pushing for the creation of a national expert panel that would oversee trial enrollment. In essence, the group would ration out participants to only those studies the experts agreed were especially important.

"I don't know who's going to be able to do this, but there's got to be some line drawn that says, 'These particular trials are really vital to move the science forward,' " Tam-McDevitt explained.

Schilsky agreed that the notion had merit. "We may have to really prioritize carefully what studies are made available to the public, so that only the highest-priority, most important studies are done," he said.

All the experts agreed that cancer patients shouldn't wait for their doctor to mention a clinical trial, but should be pro-active in seeking out what's available.

"Clinical trials should be an option for patients at every point in their oncology care," Schilsky added. "Right from the very beginning of treatment to the 'last-resort' kind of option."

Tam-McDevitt concurred. "I certainly don't advocate that every patient goes on a clinical trial, but I think it's the right of the patient to have that information," she said. "Caregivers, as well, should be involved in the process of finding out whether a clinical trial might be appropriate."

Quiros said joining a trial was certainly the right decision for him.

"At the time, I was told that I'd become sterile -- because of my condition, and because of the drugs that were standard then," he said. But Quiros took a chance on the newer medication.

"So, here I am, 15 years later, with a 5-year-old and an 8-year-old," he said.

His only worry now is that a family history of lymphoma might boost his children's risk for the disease.

"But," he said, "if they ever have to deal with that, I'd like to think that I contributed to a better treatment for them."

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