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Dr. J. Tate Thigpen, University of Mississippi Medical Center.

The advice for cancer patients to seek out clinical trials is practically ubiquitous. The National Cancer Institute, American Cancer Society, Mayo Clinic — all provide encouragement and resources for patients to seek out and find suitable clinical trials to help in the treatment of their diseases.

For Dr. J. Tate Thigpen, an oncologist at the University of Mississippi Medical Center (UMC), the reason is obvious. "Clinical trials are the only way we can validate what we've discovered in the laboratory," he said.

These days, physicians like Thigpen can present patients with a cornucopia of possibilities for treating cancer, including surgery, chemotherapy, hormonal and radiation therapies, and even various forms of immunotherapies.

Having the best standard of care and a variety of effective treatment options are veritable lifelines for those struggling with cancer. And the availability of such options is directly related to the experience and data garnered through clinical trials.

Thigpen explains that all phases of these trials are important and contribute to physicians' understanding of the treatments available to their patients. For example, phase I trials set recommended dosages and examine the toxicity levels in those who are taking the new drugs. Then, in phase II trials, which are conducted with a larger number of patients, researchers can apply the medicine to different types of cancers to see how people with these diseases respond.

But it is with the phase III trials that physicians can really bring the fruits of this research to bear on large numbers of patients and get a solid idea of just how effective they are in real-world clinical settings. These trials utilize considerably larger numbers of patients (thousands in many cases) and offer randomized treatments, wherein some patients receive the standard of care while others receive such care augmented by the newer treatment modalities being studied.

The benefits of conducting these trials? Thigpen said, "Patients in phase III studies are getting at least the standard of care, and likely even better. Because of how the trials are set up, it's not likely that they are going to get worse. For example, with ovarian, cervical, and endometrial cancers, it is clinical trials that have really led to advances in the standard of care we can offer patients."

Dr. Mike Cheng, a radiation oncologist at Forrest General Hospital in Hattiesburg, concurs. He said, "Really, with phase III trials, we're just collecting more data to see more specifically how effective these treatments are. By the time we get to a phase III trial, we know the medications work."

It would seem that doctors in general agree: the National Cancer Institute's comprehensive database, PDQ® (Physician Data Query), contains a registry of more than 4,000 open and 15,000 closed clinical trials from around the world.

Surprisingly few patients, though, participate in these literally life-saving trials. In fact, according to Debra Christie, director of cancer research and registry at UMC, only about 3 to 5 percent of patients actually participate in such trials.

So why don't more patients avail themselves of these opportunities?

"Part of it," said Christie, "is that when they think about it, patients often feel like they're being asked to serve as guinea pigs. There is some fear associated with a trial if you look at it that way."

She added, "There are so many factors involved for a patient who has been diagnosed; there is so much going on at that time. Bringing up the option of a clinical trial just adds more to the mix for them."

She also notes that as treatment options have become more complex over the years, so have the trials. One result of this is an increase in paperwork that can be overwhelming to patients. "It can be intimidating when you present someone with a 20-page set of papers," she said.

Finally, Christie adds another practical factor: each patient must meet very particular criteria to be eligible for a given trial. "Out of every 10 patients you see, maybe one meets the criteria and so might be a candidate for one of the trials," she observed.

Nevertheless, many thousands of patients do participate in clinical trials, and the benefits extend beyond their own chances and hopes for increased health. Christie said, "When a study makes a significant improvement, it changes the standard of care. So, really it benefits everyone."

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