Clinical trials are the centerpiece for the drug-testing system in the United States.
Each cancer study conducted tries to answer scientific questions and determine better ways to prevent, diagnose or treat the disease. As researchers test the effectiveness of trial drugs, patients who participate, in many cases, benefit from life-saving treatment options years before they are available to the public.
As a member of The US Oncology Network, Willamette Valley Cancer Institute and Research Center offers patients access to one of the nation’s largest research networks.
“Historically, the perspective has been that in order to get the latest, greatest, most innovative care, someone has to go to a university,” says Dr. Jeff Sharman, Medical Director of Hematology for The US Oncology Network. “WVCI’s unique affiliation with The US Oncology Network enables us to bring trials to patients in Eugene.”
The US Oncology Network has played a role in 53 FDA-approved cancer therapies, nearly one-third of all cancer therapies approved by the FDA to date.
“We’re incredibly fortunate here at WVCI to have become involved with a number of important drugs at a very early stage,” says Dr. Sharman. “We’ve had the opportunity to treat the first chronic lymphocytic leukemia (CLL) patient in the world with the drug ibrutinib, which was FDA approved a year ago. This breakthrough therapy has changed the lives of innumerable patients with the disease and was first used here in Eugene.”
How are clinical trials conducted?
Clinical trials are conducted in a series of steps, called phases, and each phase is designed to answer a separate research question.
• Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
• Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
• Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects and compare it to commonly used treatments.
“If you go back just five, ten years, we would have said that phase I studies are really for patients who don’t have any other options,” Dr. Sharman says. “But we’ve now entered this new era where new drugs can be so effective, or reduce side-effects so much, that sometimes, phase I studies offer some great opportunities for patients.”
Placebo-controlled or randomized trials
A placebo-controlled trial is a study in which the effect of a drug is compared with the effect of a placebo (an inactive substance designed to resemble the drug). A common concern of patients considering a clinical trial is that they will receive a placebo instead of the drug being tested.
“Clinical trials do not necessarily mean placebo and in fact, placebo controlled studies are very rare in oncology,” says Dr. Sharman. “Randomized trials, however, are not rare.”
In a randomized controlled trial, participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best.
Patients considering a clinical trial should know as much about it as possible, including what is being studied and what they can expect during the trial.
“What do we know about the drug? What are the side effects? Everything has side effects, but ask if those particular side effects are better than the alternative,” Dr. Sharman says.
For a list of questions to ask when considering a clinical trial, click here.