Cancer clinical trials measure whether new therapies or new combinations are better than the best treatments we have today. Today’s cancer treatments were carefully evaluated in clinical trials before being approved for wider use.
Interested participants are screened to make sure the trial is right for them and safe in their particular case. Making sure patients meet the criteria for the trial also helps ensure that the data produced by the trial is meaningful.
For example, if a trial is looking at a treatment that targets a mutation in the BRCA gene, only people with that mutation will qualify. Other factors such as the type of disease, stage of the cancer, previous treatments, results of specific lab tests and your medical history may be taken into account as well.
You may want to consider all your options from the beginning. See what trials are being conducted that “fit” your situation and, together with your doctor, decide if one of them might be right for you. Some clinical trials are designed to study patients who have not yet received treatment, so some clinical trials might be your best “first line” treatment.
Some people think of clinical trials as a last resort. Given the exclusion criteria of many trials, waiting to participate until after an initial treatment has failed might disqualify you from participating in certain trials.
It takes years before a new treatment reaches the market. First, several cancer clinical trials are conducted in a series of steps—or phases.
Trials need to be designed in a way that will produce useful data. Researchers must be able to show whether a benefit seen in a trial is actually a result of the treatment being studied. Likewise, they must figure out whether any side effects are caused by the treatment. And they need to do all that using a population of patients who are each unique individuals.
Standard of care or standard treatment is a therapy that is currently widely used to treat a specific disease. Cancer clinical trials are conducted in the hopes of finding new treatments that are better than the existing standard of care or to create a standard of care if one does not already exist.
One way researchers can isolate the effects of a study treatment is through randomized controlled trials. This is helpful when comparing the investigational treatment to the standard of care.
Participants are randomly assigned by a computer to either the “investigational group” that receives the investigational therapy or a “control group” that receives the standard treatment. Randomly assigning participants helps to create two similar groups for comparison.
Trials may be designed in a variety of ways. Some have no control group, while others may have a control group and more than one investigational group, in order to test different dosing or treatment combinations.
In addition, some trials are “blinded”. In single-blinded trials, the participants don’t know which treatment they are receiving until the trial is over. In double-blinded trials, neither the participants nor their doctors know which treatment is being given.
Blinding helps to prevent bias in terms of how patients and their doctors might perceive or report how they’re doing.
Patients in both groups, experimental and standard of care, are closely monitored by the doctors on the study.
People are sometimes concerned that if they enroll in a clinical trial, they might receive a placebo (a “sugar pill” or other inactive treatment). Actually, placebos are rarely used in cancer clinical trials. When they are used, they are usually combined with the standard treatment you would receive if you weren’t in the trial.
If you are considering participation in a clinical trial, you will be told whether it involves use of a placebo. Unless a particular cancer has no available treatment, you will always receive an active treatment in a cancer clinical trial.
Cancer clinical trials provide knowledge that advances cancer care. Every participant adds to that knowledge. Researchers learn which patients are likely to respond to which drugs, learn more about how cancer works, and may also discover approaches that work for other cancers.
Even when a study drug doesn’t prove to be better than the standard treatment, researchers still learn from those trials. Sometimes all it takes is a dose adjustment. Other times, using a drug in combination makes the difference. Or it may be that they need to move on to the next promising idea.
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