Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021:2249:213-227.
doi: 10.1007/978-1-0716-1138-8_12.

Randomized Controlled Trials 2: Analysis

Robert N Foley  1 , Patrick S Parfrey  2
Affiliations

Randomized Controlled Trials 2: Analysis

Robert N Foley et al. Methods Mol Biol. 2021.

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, subgroup analysis, competing risks, and hypothesis-generating analyses.

Keywords: Analysis; Competing risks; Composite outcomes; Intention to treat; Multivariate modeling; Randomized controlled trials; Research design; Statistical power; Stopping rules; Subgroups.

PubMed Disclaimer

Similar articles

See all similar articles

References

    1. Miller AB, Wall C, Baines CJ, Sun P, To T, Narod SA (2014) Twenty five year follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomised screening trial. BMJ 348:366–376 - DOI
    1. Pocock SJ (1997) Group sequential methods in the design and analysis of clinical trials. Biometrika 64:191–200 - DOI
    1. Haybittle JL (1971) Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol 44:793–797 - DOI
    1. O’Brien PC, Fleming TR (1979) A multiple testing procedure for clinical trials. Biometrics 35:549–556 - DOI
    1. Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C (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 - DOI

LinkOut - more resources