• Maria Kabisch, Christian Ruckes, Monika Seibert-Grafe, and Maria Blettner.
• Interdisziplinäres Zentrum Klinische Studien-IZKS, Universitätsmedizin der Johannes-Gutenberg-Universität Mainz.
• Dtsch Arztebl Int. 2011 Sep 1; 108 (39): 663668663-8.

BackgroundIn clinical research, randomized controlled trials (RCTs) are the best way to study the safety and efficacy of new treatments. RCTs are used to answer patient-related questions and are required by governmental regulatory bodies as the basis for approval decisions.MethodsTo help readers understand and evaluate RCTs, we discuss the methods and qualitative requirements of RCTs with reference to the literature and an illustrative case study. The discussion here corresponds to expositions of the subject that can be found in many textbooks but also reflects the authors' personal experience in planning, conducting and analyzing RCTs.ResultsThe quality of an RCT depends on an appropriate study question and study design, the prevention of systematic errors, and the use of proper analytical techniques. All of these aspects must be attended to in the planning, conductance, analysis, and reporting of RCTs. RCTs must also meet ethical and legal requirements.ConclusionRCTs cannot yield reliable data unless they are planned, conducted, analyzed, and reported in ways that are methodologically sound and appropriate to the question being asked. The quality of any RCT must be critically evaluated before its relevance to patient care can be considered.

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