Clinical Trials News

From NPR:

Advice From Patients On A Study’s Design Makes For Better Science

Many studies designed to try out new drugs simply languish. They don’t attract enough patients, and they aren’t completed. That slows medical progress.

But here’s a story of one study that has bucked that trend — in fact, it is so popular, scientists had to put the brakes on it for a while.

The study is called the NCI-MATCH trial. It upends the normal way of classifying cancers for treatment: Instead of categorizing malignancies by the organ where they first appear, this method of sorting focuses on particular mutations in the genes of cancer cells.

“Instead of thinking of a breast cancer treatment or a lung cancer treatment or colon, it looks at the different mutations that occur in the tumors,” explains oncologist Robert Comis, who leads the study.

NCI-MATCH recruits people who have tried and failed the traditional cancer treatments. People like 74-year-old Nancy Nahmias.

“It all started when I was diagnosed with cancer of the liver,” Nahmias says. “I was put on chemo, which I reacted very poorly to.” In fact, she developed a severe reaction called sepsis, which put her in the hospital for six weeks.

Standard chemotherapy was out of the question, her doctors told her.

Nahmias’ daughter, a physician, learned about the NCI-MATCH trial and encouraged her mother to give it a try. Scientists screened the genetic pattern of her tumor and found a mutation that might be amenable to a treatment not usually given to patients who have liver cancer. Nahmias signed up about two months ago, at Thomas Jefferson University, one of many sites running the study.

The study has been recruiting patients at a record pace. In its first three months it enrolled 800 patients, far more than the 150 the researchers expected, Comis says.

The organizers had to pause the study briefly, to reconfigure their labs to keep up with the flood of patients.

That rapid clip is no doubt because the study is aimed at patients who are running out of traditional treatment options.

But it’s also because the researchers who designed the study stopped to ask what would appeal to potential participants. Nancy Roach, a longtime patient’s advocate who lives in rural Oregon, got involved early on, and helped advise the scientists planning this study.

Know your audience

“This is going to sound goofy, but my dad was in advertising,” she says. “Remember the scrubbing bubbles — Dow scrubbing bubbles? That was my dad. So I grew up watching commercials and thinking about what consumers wanted.”

Roach brought that sensibility to the conferences where the NCI-MATCH trial was being designed. The original plan would have split the study participants who seem to be doing well on the test treatment into two groups. One group would continue the treatment; the other would take a break, called a drug holiday.
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