THE INS AND OUTS OF CLINICAL TRIALS

There are currently around 50,000 clinical trials underway in the US, according to the Center for Information and Study on Clinical Research Participation; but 80% of these are delayed at least a month because of unfulfilled enrollment. In a medical climate where new drugs can take up to 15 years to reach the market, every minute counts. So why do clinical trials still face recruitment problems?

"Everyone is afraid of getting a placebo," said Gwen Darien, director of survivor and patient advocacy at the American Association for Cancer Research and editor-in-chief of CR magazine. "Conversations about clinical trials don't tend to be very nuanced, and one thing people don't understand is that you're not a guinea pig. You're receiving an experimental drug, but it's a drug that has shown evidence of being an effective treatment. That's why it's being tested."

In fact, it's very rare that a patient in a clinical trial will receive a placebo, says Dr. James Doroshow, director of the division of cancer treatment and diagnosis at the National Cancer Institute. "The control arm is almost always what is thought to be the standard of care," he explained. "The randomized trials that the NCI supports usually involve testing drugs A, B and C against drugs D, C and F, or surgery plus drug against surgery alone. Just receiving a new treatment is extremely rare."

But this misconception isn't the only factor that contributes to the lack of enrollment in clinical trials. Dr. Bob Young, chairman of the board of scientific advisors for the NCI and former president of the Fox Chase Cancer Center, says there are multiple factors: "Patients don't know where to find them," he said. "Or their doctor either doesn't know about them or doesn't want to participate. Clinical trials are complex – they often require additional work on the part of the physician, and there are only 24 hours in a day."

That was Darien's experience while undergoing treatment for stage II non-Hodgkin's lymphoma. During the time she was treated, a clinical trial was underway for Rituxin, which has subsequently become the standard of care for the disease. But Darien was never asked to participate. "It isn't something you come in thinking about, and my doctor didn't offer the possibility," she said. "It's possible that there was nothing available for me at that point, but even in subsequent years I wasn't asked to participate in any quality of life trials or survivorship trials.

"Everyone says when you go into the doctors' office, have a list of questions," she continued. "And one question you should ask is am I eligible for any clinical trials."

There's also a psychological factor. "There are many people who want their doctor to tell them what the best treatment is and then get it," Young said. "It frightens them to think that they're participating in a study. They want their doctor to definitively tell them that treatment B is the right treatment for them."

Doroshow concurs. "There's a lot of patient choice that goes into this, and there are individuals who simply do not want a computer to decide," he said. "There are patients who just don't like that. I have experienced that perspective from individuals of every education level – it's very personal. Getting one treatment or another based on randomization is not everyone's cup of tea."

So why should patients enroll in clinical trials? Young has a few answers. "Clinical trials are good for patients," he said. "They're generally performed in institutions in the context of people who have a particular expertise or special interest in that disease. One of the things that is seen in clinical trials is that if you're testing whether new treatment A is better than standard treatment B, very frequently the patients on the standard treatment alone do better than the average patient because the people involved with their care have so much experience with the disease."

And that's not the only reason. "The faster we get done with trials, the faster we know whether treatment A is better than treatment B," said Young. "We learn that certain things work and other things don't, and with the cost of medical care always on the rise, that's very important."

The high cost of medical care: it's a topic familiar to most Americans as premiums inflate and paychecks shrink. Unsurprisingly, it also plays a role in clinical trials. "For a practice to participate in clinical trials, there is a major intellectual as well as financial commitment that has to be made," said Doroshow. "It takes time, and that time is very tough to make available. You need additional personnel."