BACKGROUND: In 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. METHODS: To 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. RESULTS: The 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. CONCLUSION: RCTs 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.
BACKGROUND: In 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. METHODS: To 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. RESULTS: The 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. CONCLUSION: RCTs 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.
Authors: Catherine De Angelis; Jeffrey M Drazen; Frank A Frizelle; Charlotte Haug; John Hoey; Richard Horton; Sheldon Kotzin; Christine Laine; Ana Marusic; A John P M Overbeke; Torben V Schroeder; Hal C Sox; Martin B Van Der Weyden Journal: Lancet Date: 2004 Sep 11-17 Impact factor: 79.321
Authors: Bernd Röhrig; Jean-Baptist du Prel; Daniel Wachtlin; Robert Kwiecien; Maria Blettner Journal: Dtsch Arztebl Int Date: 2010-08-09 Impact factor: 5.594
Authors: Sabine Stamm-Balderjahn; Martin Brünger; Anne Michel; Christa Bongarth; Karla Spyra Journal: Dtsch Arztebl Int Date: 2016-08-08 Impact factor: 5.594
Authors: Leonardo Almeida; Bilal Ahmed; Roger Walz; Sol De Jesus; Addie Patterson; Daniel Martinez-Ramirez; David Vaillancourt; Dawn Bowers; Herbert Ward; Michael S Okun; Nikolaus R McFarland Journal: Mov Disord Clin Pract Date: 2016-06-24