Participating in a clinical trial has the potential to help both the participant and others who have or may develop cancer.
- You can gain access to drugs and treatments before they are widely available.
- You can receive expert medical care at leading healthcare facilities often covered by the trial sponsor and/or insurance and Medicare.
- You can play a more active role in your own health care.
- You can help future generations by contributing to cancer research.
Clinical Trials: Glossary
Phase I Trials: The first stage of studies in people. These trials evaluate the safety and dosage of a new drug or treatment.
Phase II Trials: These studies further test the safety of a drug or treatment and begin to
evaluate how well the new drug works.
Phase III Trials: These studies confirm the effectiveness of the study drug or treatment and compare it to the current standard of care.
Randomized Trial: A trial design in which participants are assigned by chance to a treatment group. The researchers do not know which treatment is better.
Double-Blind Study: A design in which neither the participating individuals nor the study staff know which participants are receiving the experimental drug.
Controlled Trials for Cancer: One group of participants is given the standard of care (this is the control group), while another group is given the standard treatment plus an experimental drug or therapy.
Placebo: A placebo is an inactive pill, liquid or powder that has no treatment value.
First Line Study: These studies evaluate treatments given first after cancer has advanced.
Second Line Study: These studies evaluate second treatments or therapies after cancer has advanced and the first line therapy is no longer working.
Myth: Clinical trials are a last resort.
Fact: Clinical trials should always be considered as an option for treatment. There are trials for nearly every type and stage of cancer.
Myth: If I participate in a clinical trial I may receive a placebo.
Fact: Placebos are not used in clinical trials that test cancer treatments. Patients either receive the new treatment or the best standard of care. Placebos may be used in trials to test drugs that may prevent cancer but the people participating in the trial would not have cancer.
Myth: Clinical trials are not safe.
Fact: Clinical trials are conducted on humans only after there is scientific evidence that treatments are likely to be safe and effective. In fact, in Phase III clinical trials the treatment or drug have already been tested on small numbers of patients for safety and effectiveness.
Myth: I won’t receive good care if I join a clinical trial.
Fact: Most cancer survivors who have taken part in a clinical trial were very satisfied with their experience according to a study conducted by the Coalition of Cancer Cooperative Groups. 92% reported a positive experience and 91% said they would recommend participating in a clinical trial to a friend.
Myth: I will feel like a “guinea pig” if I participate in a clinical trial.
Fact: According to a study conducted by the Coalition of Cancer Cooperative Groups more than 90% of those surveyed reported that they were not subjected to more tests and procedures than necessary and rejected the notion that they felt like a guinea pigs.
Myth: If I join a clinical trial I can’t get out of it if I change my mind.
Fact: You may quit a clinical trial at any time.
Myth: My insurance won’t pay for a clinical trial.
Fact: Many states, including Virginia, require that insurance companies cover routine costs of care in a clinical trial. Medicare began covering routine costs for clinical trials in 2000. If you are receiving an experimental, new breast cancer treatment in addition to routine breast cancer care, the trial sponsor is responsible for the new cancer treatment while many insurers will cover the remaining costs.
Myth: I can only participate in a clinical trial if I live near a large cancer center.
Fact: Clinical trials take place throughout the country at local hospitals, local cancer clinics and doctor’s offices. We are fortunate in Virginia to have two National Cancer Institute designated cancer centers – Massey Cancer Center in Richmond and the UVA Cancer Center in Charlottesville.