Planning of clinical trials.
This article focuses on steps of planning clinical trials most relevant to the question the clinician asks and how this question is properly transformed in a design and a protocol. All steps are important for the data quality or the validity of the results. A clinical trial is an experiment aimed at testing an hypothesis regarding the efficacy of a given intervention on an event, symptom or impaired quality of life in patients with a defined condition and a particular profile. As such, it should meet the fundamentals of scientific discovery that guarantee causality between the observed difference and the intervention. All the planning components are thought according to these fundamentals.
Boissel
J-P
JP
Clinical Pharmacology Department, RTH Laennec School of Medicine, Lyon Cedex, France. jpb@upcl.univ-lyon1.fr
D035061:Control Groups; D004311:Double-Blind Method; D006801:Humans; D008954:Models, Biological; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D012107:Research Design; D018401:Sample Size; D013223:Statistics as Topic