N117 - Clinical Trials Questions & Correct Answers | Grade A+

what is a clinical trial? : prospective experiment on humans; must have an intervention, should compare to a "control"; goal is usually to examine safety and/or efficacy of a therapeutic intervention Is it a drug? : drug is any article "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals." What is the purpose of a clinical trial? : set out to answer a question and/or test a hypothesis What is a protocol? : a written document describing the means by which the hypothesis will be tested What is the primary objective? : goal of the study 2 what is the primary outcome? : measures used by the protocol to support or reject the null hypothesis what is the null hypothesis? : treatment is no different from placebo what must the hypothesis include? : population studied, primary outcome of interest, intervention studied, period of observation randomized : each participant has equal probability of being assigned to a study arm double-blin