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Gold Study What Constitutes a "Gold Standard" Study
Patients selected for the study are randomly assigned to receive the drug being tested or a non-drug placebo. Physician investigators have no control over the randomization process. Patients selected for the study have the physical and physiologic characteristics necessary for the study -for example, they have female pattern hair loss within designated degrees of severity.
A study protocol is written to assure that (1) patients selected for the study have the characteristics necessary to test the drug versus placebo, (2) the study will be conducted for a period of time necessary to obtain valid results, (3) the number of patients in the study is statistically meaningful, and (4) the study design is statistically sound.
Neither patients nor investigators can know which patients receive the drug and which the placebo until the study is completed - the study is double blind.
The effects of the test drug are compared to the effects of placebo in patients who received the drug versus those who received the placebo - the study is placebo-controlled.
The study is simultaneously conducted at several medical research centers by investigators at each site who follow the study protocol.
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