What You Should Know About Clinical Studies

Posted By SHL Librarian

Presented by: George A. Fisher, MD, PhD
Associate Professor; Faculty Director, Cancer Clinical Trials Office
Stanford University Medical Center
January 26, 2011

Lecture Overview:

Clinical trials play an essential part in discovering new weapons to fight cancer, but are sometimes misunderstood. Boosting partcipation in this research is key to dicovering new and effective cancer drugs.

From his work as the faculty director of Stanford’s Cancer Clinical Trials Office, George Fisher MD, PhD is keenly aware of what a critical role clinical trials play in finding effective new cancer drugs. Unfortunately, however, most cancer patients don’t realize that they might be eligible to be part of a clinical trial, or, even worse, don’t understand what clinical trials are.

“We simply don’t make any progress against cancer without clinical trials,” Dr. Fisher said during a recent talk sponsored by the Stanford Health Library. “The problem is, only three, maybe four percent of patients who are diagnosed with cancer ever enter a clinical trial.”

Dr. Fisher, who also is an associate professor at the Stanford University Medical Center, said the simplest way to boost the probability of finding a new and useful cancer treatment is increasing the number of people who participate in clinical trials. If the percentage of adults who take part were doubled, “I could double the chance of finding the next great drug,” he said.

Pros and Cons
While some might hesitate to join a clinical trial, there are distinct benefits to doing so, said Fisher, who noted that every standard cancer treatment drug today was an experimental drug a decade ago.

For one, if a new approach being tested is proven to work, the patient will be among the first to benefit. There’s never a promise that the drug being tested will be better, but the chance is always there, Dr. Fisher said. Also, because of the need to carefully document every symptom to determine whether it is related to the drug, patients taking part tend to get more care than they would otherwise.

“Do you want cutting-edge cancer care, or care that was cutting edge 10 years ago?” Dr. Fisher asked.

Yet there are some potential downsides to taking part in a trial. Although the treatments are seldom worse than standard care, they are not always better. There can be unexpected side effects, additional appointments, and in some cases, travel to clinical trial centers.

Clinical Trial Phases
The clinical trial process is broken up into three phases. The first focuses on determining which dosage is safe for people, how the treatment should be given, and how it affects the body. These are referred to as Phase I trials. Phase I drugs have already demonstrated substantial promise in the laboratory but have not yet been studied extensively in patients.

Phase one trials usually involve 15 to 20 patients, take between one and two years to complete, tend not to be restricted to a particular type of tumor, and usually are targeted at patients in advanced stages of cancer. Once potential side effects are determined by administering small doses to trial participants, the testing goes to the next stage.

In phase two, the goal is to determine the effectiveness of the drug. Once a trial reaches this point, the number of patients is expanded to anywhere between 35 and 60 people, but is usually restricted to one type of cancer. The hunt for side effects continues through this stage, which normally takes two to five years to complete.

“The question you are asking is: What percentage of patients with this kind of cancer have gotten a benefit?” Dr. Fisher said.

Phase three clinical trials essentially compare the new drug’s effectiveness and side effects to those of the standard therapy for a particular disease.

“It’s hard to compare this,” Dr. Fisher noted. “We must do a randomized sample of hundreds, sometimes thousands, of patients. This could take three to 10 years.”

If the results of a Phase III trial are encouraging (i.e. the experimental drug has better outcomes than the “standard” therapy), the FDA then decides if the data are sufficient to approve the drug for widespread use. Until a drug is approved by the FDA, the only way to get access to the drug is by entering a clinical trial.

Clinical Trials’ Impact
There are times, Dr. Fisher noted, when people question the usefulness of cancer research. Such has been the case with mammograms, where there has been much back and forth over the usefulness of this kind of imaging.

“Sometimes the statistics are not so consistent,” Dr. Fisher said. “That’s where people start losing faith in the system.”

Yet there is no denying the successes that clinical trials have achieved. Take the very first trial every conducted by the American Cancer Society, of which Dr. Fisher is a past president of the California division. The group’s research confirmed the link between smoking and lung cancer. That research eventually lead to landmark legislation to combat tobacco use.

Dr. Fisher is involved with the latest legislative fight against cancer, pushing to enact the California Cancer Research Act, which would place a $1 tax on each pack of cigarettes sold in the state. That money would go to cancer research, Dr. Fisher said, potentially boosting funding by as much as $500 million per year. Increasing the price of cigarettes also could have a positive effect on the habits of one of the biggest target audiences for tobacco companies.

“Every time you increase the cost of a pack of cigarettes, teenage smoking goes down,” Dr. Fisher said. “If we banned smoking, we’d cut out a third of all cancer.”

He admits that eradicating smoking altogether might be a pipe dream, but the more funding dedicated to clinical trials, the better armed researchers like Dr. Fisher will be be to fight cancer.

To speak with a clinical trials recruitment specialist, one can call (650) 498-7061 or email cctofice@stanford.edu.

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