Abstract Wrong results from clinical trials occur because of (1) mistakes by researchers in the planning and execution of clinical trials, (2) the complex and inexact nature of information researchers require and (3) factors that are beyond the control of the researcher. This chapter examines the last element and identifies seven fatal flaws that are inherent in the methodology of clinical trial:
-
The unknown population
-
The imperfect sample
-
The unequal treatment groups
-
The uncontrolled experimental setting
-
The breakdown of blinding
-
The impractical result
-
The insufficient sample size
These seven elements may or may not contaminate a trial and even if they do, they may not cause a significant distortion of the results. However, it'rtually impossible to know if their presence or their effect occurred, and as a result, researchers can never be certain that their study came up with all the right answers.
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
Preview
Unable to display preview. Download preview PDF.
Chapter 12 — Seven Deadly Flaws
Cited References
Blum A, Chalmers T. The Lugano statements on controlled clinical trials. J Int Med Res 1987:15;2–22.
Carey B. Study pursues a genetic link to depression. New York Times Dec 10, 2004:A36.
Cochrane A. Effectiveness and efficiency: random reflections on health services. Abingdon, UK: The Nuffield Provincial Hospitals Trust, 1972.
Editorial. Cranberg L (ed). Evaluating new treatments. Br Med J 1998:317;1260.
Freiman J, Chalmers T, Smith H, et al. The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 “negative” trials. New Engl J Med 1978:299;690–694.
Furukawa T, Streiner D, Hori S. Discrepancies among megatrials. J Clin Epidemiol 2000:53;1193–1199.
Halpern S, Karlawish J, Berlin J. The continuing unethical conduct of underpowered clinical trials. JAMA 2002:288;358–362.
Hemminki E. Quality of clinical trials — a concern of three decades. Methods Inf Med 1982:21;81–85.
Ioannidis J. Why most published research findings are false. PLoS Med 2005:2;e124.
General References
Baum M. Contribution of randomised controlled trials to understanding and management of early breast cancer. Br Med J 1999:319;568–571.
Ely J. Confounding bias and effect modification in epidemiologic research. Fam Med 1992:24;222–225.
Peto R, Baigent C. Trials: the next 50 years: large scale randomized evidence of moderate benefits. Br Med J 1998:317;1170–1171.
Rights and permissions
Copyright information
© 2009 Springer Science + Business Media B.V
About this chapter
Cite this chapter
(2009). Seven Deadly Flaws – The Clinical Trials' Achilles' Heel. In: It's Great! Oops, No It Isn't. Springer, Dordrecht. https://doi.org/10.1007/978-1-4020-8907-7_12
Download citation
DOI: https://doi.org/10.1007/978-1-4020-8907-7_12
Publisher Name: Springer, Dordrecht
Print ISBN: 978-1-4020-8906-0
Online ISBN: 978-1-4020-8907-7
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)