If I Enter a Cancer Clinical Trial, Is There a Chance I will Receive a Placebo Instead of Cancer Therapy?
Only when a cancer clinical trial involves people with treatment-resistant or progressive cancer would a placebo be given. Participants are always informed they may receive a placebo prior to the start of the trial and have the option of leaving the trial if they do not wish to continue.
Double-blind controlled studies incorporating a placebo group do so to “blind” physicians and subjects to the kind of the treatment received. In other words, only the researchers know who is taking a placebo. This avoids bias when measuring results of the study, especially results provided by doctors examining participants.
Informed Consent and Placebos in Cancer Clinical Trials
An informed consent document tells trial participants they may receive a placebo during the course of the experimental treatment. Even patients undergoing standard cancer treatments will be asked to sign a consent form explaining risks associated with a certain surgery or procedure. Signing a consent form means the person has agreed to undergo the treatment and understands risks or implications involved with the treatment.
If clinical trial participants are not permitted to sign an informed consent document regarding the use of placebos in a trial and find out they were given placebos, the institution performing the trial could be sued by the participants for unethical practices. In addition, the FDA and other regulatory organizations could revoke the institution’s ability to perform any further trials involving experimental therapies.
Problems With Placebos in Cancer Trials
Research into the placebo effect is ongoing and has yet to provide empirical of physiological mechanisms supporting its efficacy. Another problem with using placebos in any trial is called the “wellness effect”, or the ability of certain health problems to improve without treatment. This may be due to people taking better care of themselves because they think they will get better or because of the beneficial effects of enhanced mood and general well-being.
Some researchers think placebos may actually facilitate remembering a time before symptoms of a disease emerged and the person began feeling sick. Neurologists call this theory remembered wellness and suspect a combination of the placebo effect and remembered wellness may incite beneficial chemical changes in the brain to reverse certain medical conditions.
If done properly, a placebo-controlled, cancer clinical trial can provide significantly statistical evidence that a new cancer treatment holds promise. Alternately, placebos used improperly may provide erroneous evidence that inadvertently allows marketing of a new, possibly harmful drug.
If you would like more information about the use of placebos in cancer clinical trials, please contact us today.