Clinical Trial FAQs
A: Clinical trials are the first point of testing new treatments in people and the last point of testing treatments prior to FDA (Food and Drug Administration) approval or disapproval. Prior to the clinical trials, experimental treatments are tested, generally for years, first in the laboratory and then on animals. Treatments that work in mice and other animals or in the lab may or may not work for people.
Clinical trials first test the new treatment outside the lab in a real-life environment to see if it is safe for humans, then to determine if it works as well as or better than the existing treatment.
Cancer clinical trials test new approaches for treating or diagnosing cancer. The new approach may involve one or more drugs, a diagnostic test, a gene therapy, or other options, and may focus on issues such as prevention, detection, treatment, quality of life, or the impact of behavior modification. Cancer treatment trials differ slightly from other clinical trials because cancer trials ensure that all participants get either the standard treatment (that is, the already approved or accepted treatment) or the experimental treatment. In non-cancer treatment trials, participants may be randomly placed in a group that gets no treatment (or a placebo) as part of the trial.
Q: Should I consider being part of a clinical trial?
A: Clinical trials are widely considered as offering cancer patients high-quality, state of the art medical care. According to CenterWatch, a medical information services company, people who volunteer for Phase 2 and Phase 3 trials can gain access to promising drugs long before these compounds are approved for the marketplace.
There are many reasons why a patient may not enroll in a clinical trial. For example, their doctor may not conduct or participate in trials and may not encourage the patient to participate. Some patients might be reluctant to participate because of their concerns about costs, travel, and how trials are actually conducted. The research sponsor generally pays for costs of the experimental drugs and tests that are specific to the study. Potential risks in a clinical trial include financial risks, potential insurance complications and physical risks and the possibility of an unexpected side effect. "Patients are closely monitored throughout the trial; problems are identified quickly and if the patient doesn't tolerate the treatment, he or she leaves the trial and resumes the standard treatment," says Dr. John Marshall, colorectal cancer research oncologist and member of CCA's Science Advisory Board.
Q: What are the system checks to keep me safe?
A: "Informed consent" protects trial participants by ensuring that investigators fully inform their patients about the benefits and risks of participation. When researchers set up a trial, their procedures for safeguarding the privacy and safety of trial participants are carefully reviewed by both the Federal Drug Administration and the participating cancer center's Institutional Review Board (IRB).
As an experimental drug moves through the clinical trial process, safety, effectiveness and side effects are compared to the standard accepted treatment. If a treatment shows negative results for most patients, it is discontinued. If a treatment is benefiting most patients, others in the trial will be switched to that beneficial treatment. It is important to note that patients can leave the trial at any time and for any reason. When a patient leaves a clinical trial he or she may resume the standard treatment or explore other clinical trials.
Q: Why think about a clinical trial? The big picture...
A: Forty years ago, the vast majority of children with cancer died. Today, most of them live. How did that happen? One contributing factor is the lessons learned from extensive clinical research that occurs in children with cancer. Over 70% of children with cancer receive their treatment through clinical trials compared to only 2-3% of adults with cancer. More patients in more trials can mean faster development of new and promising options. The National Cancer Institute is working to increase adult clinical trial participation to 10-15% by 2003 in order to reduce drug development time.
"In a broad sense, clinical trials provide valuable scientific information leading to better cancer treatments, and so patients participating in clinical trials are helping all cancer patients by moving the research forward," says Dr. Marshall. "If I had it to do over, I would go through a clinical trial," says Lewis. "Colon cancer patients need better treatment options for the future."