Most Clinical Trials are “double blind”meaning that neither the patient nor the medical team know what medication or dose they are receiving until the study is over. Occasionally studies are “open label” where everyone knows what treatment the patient is getting. Less frequently studies can be single ” single blind” where one of the parties is aware of the treatment and the other is not.
In addition most trials involve a placebo which is a tablet that looks like the test medication but has no active ingredients. These trials compare the safety and efficacy of a new medication to a placebo or no treatment. This can pose an ethical dilemma when a trial is evaluating a medical condition that has good medical options, hence participating in a trial may result in the individual not being treated for their medical issue
Occasionally trials use a comparator drug or different doses of the study drug however the most effective way to test the efficacy and safety of a product is in a placebo controlled double blind trial which is ” the gold standard” .
I tell my patients that enrolling in a trial is important to help bring new safe treatment options to the market and does not always benefit those participating. Communication between the study team and study participant is crucial for a study to be successful.
-Dr. Howard Schwartz M.D. – Gastroenterologist
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