Beth Nocera was a fighter, her husband Louis recalls. She bravely battled breast cancer for six years. She endured surgery, chemotherapy, radiation and multiple drug treatments. She fought to get into a clinical trial for Herceptin, but her previous treatment made her ineligible. She signed up for a lottery that the drug manufacturer had established to distribute its scarce supplies. Her number didn't come up. In July 1998, after nearly a year on a waiting list, she finally got her Herceptin. But by then the cancer was so widespread that Nocera, 41 and the mother of two, was dead within three months.

Going strictly by the numbers, Nocera's case is not typical. Most clinical trials—80%, according to one report—have trouble mustering enough volunteers to get started. But for the desperately ill, a clinical trial often represents one last chance—even if that chance is participation in a Phase I study unlikely to help them. "The cancer patients I work with are an ignored species," says Duke University researcher Dr. Johannes Vieweg. "Nobody wants to deal with them because there's so little that can be done. We try to address their unmet needs."

Vieweg, who is attempting to develop vaccines for prostate and kidney cancer using a patient's own white blood cells, is acutely aware of the heartbreaking dilemma posed by clinical trials. "We make it clear that we cannot promise cures. We make it clear that there is the possibility of adverse effects. We tell them the benefit is probably to the next generation of patients. And yet we know these patients are clinging to the hope that this will have an impact on their tumor." How can they not?

In fact, it is clear that many patients derive benefit just from taking part in a trial, independent of the effectiveness of the drug they are testing. That's because most trials involve multiple visits and substantial doctor-patient interaction. "Besides a clinical improvement," says Vieweg, "the second best thing you can give patients is the feeling that they are being taken care of, that you are interested in the particulars of their disease, their progress and what they have to cope with in their daily lives. It's an incredibly important aspect of what we do."

It isn't just the terminally ill who benefit from the attention. Researchers point to cases of medically neglected or poorly informed subjects who come out of their trials with a much better understanding of what exactly is wrong with them—including previously undiagnosed conditions.

Yet clinical trials can be frustrating even when a new drug works perfectly. Jordan Perlow, an Arizona obstetrician, has been plagued by severe psoriasis for 25 years. Last year he took part in a clinical trial for an experimental drug that completely cleared it up. He was ecstatic. But when the trial came to an end, so did his access to the drug. His psoriasis returned. With any luck, the compound he tested will win approval, but there is no guarantee. Meanwhile, Perlow is seeking relief in another clinical trial.

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