Abstract
When analyzing the results of a trial the primary outcome variable must be kept in clear focus. In the analysis plan consideration must be given to comparing the characteristics of the subjects, taking account of differences in these characteristics, intention to treat analysis, interim analyses and stopping rules, mortality comparisons, composite outcomes, research design including run-in periods, factorial, stratified, and crossover designs, number needed to treat, power issues, multivariate modeling, and hypothesis-generating analyses.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Similar content being viewed by others
References
The Diabetes Control and Complications Trial Research Group (1993) The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329:977–986
Pocock SJ (1977) Group sequential methods in the design and analysis of clinical trials. Biometrika 64:191–199
Haybittle JL (1971) Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol 44:793–797
O’Brien PC, Fleming TR (1979) A multiple testing procedure for clinical trials. Biometrics 35:549–556
Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M, Reddan D, Investigators CHOIR (2006) Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 355:2085–2098
Frick MH, Elo O, Haapa K, Heinonen OP, Heinsalmi P, Helo P, Huttunen JK, Kaitaniemi P, Koskinen P, Manninen V et al (1987) Helsinki Heart Study: primary-prevention trial with gemfibrozil in middle-aged men with dyslipidemia. Safety of treatment, changes in risk factors, and incidence of coronary heart disease. N Engl J Med 317:1237–1245
Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C (2003) Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA 289:2554–2559
Packer M, O’Connor CM, Ghali JK, Pressler ML, Carson PE, Belkin RN, Miller AB, Neuberg GW, Frid D, Wertheimer JH, Cropp AB, DeMets DL (1996) Effect of amlodipine on morbidity and mortality in severe chronic heart failure. Prospective Randomized Amlodipine Survival Evaluation Study Group. N Engl J Med 335:1107–1114
Grizzle JE (1965) The two-period change-over design and its use in clinical trials. Biometrics 21:461–480
Sibbald B, Roberts C (1998) Understanding controlled trials. Crossover trials. BMJ 316:1719
Freeman PR (1989) The performance of the two-stage analysis of two-treatment, two-period crossover trials. Stat Med 8:1421–1432
Laupacis A, Sackett DL, Roberts RS (1988) An assessment of clinically useful measures of the consequences of treatment. N Engl J Med 318:1728–1733
http://www.clinicaltrials.gov/ct/search;jsessionid=A244B49D3229182015D991D216151230?term=choir&submit=Search Accessed April 2007
Hansson L, Zanchetti A, Carruthers SG, Dahlof B, Elmfeldt D, Julius S, Menard J, Rahn KH, Wedel H, Westerling S (1998) Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group. Lancet 351:1755–1762
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2015 Springer Science+Business Media New York
About this protocol
Cite this protocol
Foley, R.N. (2015). Randomized Controlled Trials 2: Analysis. In: Parfrey, P., Barrett, B. (eds) Clinical Epidemiology. Methods in Molecular Biology, vol 1281. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-2428-8_10
Download citation
DOI: https://doi.org/10.1007/978-1-4939-2428-8_10
Published:
Publisher Name: Humana Press, New York, NY
Print ISBN: 978-1-4939-2427-1
Online ISBN: 978-1-4939-2428-8
eBook Packages: Springer Protocols