Author + information
- Received September 24, 2015
- Revision received October 23, 2015
- Accepted October 25, 2015
- Published online December 22, 2015.
- ∗Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom
- †Columbia University Medical Center, New York-Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, New York
- ↵∗Reprint requests and correspondence:
Prof. Stuart J. Pocock, Department of Medical Statistics, London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom.
This paper provides practical guidance on the fundamentals of design for major randomized controlled trials. Topics covered include the choice of patients, choice of treatment and control groups, choice of primary and secondary endpoints, methods of randomization, appropriate use of blinding, and determination of trial size. Insights are made with reference to contemporary major trials in cardiology.
- avoidance of bias
- randomized controlled trial
- sample size
- selection of patients
- study design
- treatments and endpoints
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 24, 2015.
- Revision received October 23, 2015.
- Accepted October 25, 2015.
- 2015 American College of Cardiology Foundation