One of the signature characteristics of a clinical trial is the use of a contemporaneous control group. The evaluation of a new treatment without a rational comparison group is extremely vulnerable to error. Historical and anecdotal accounts illustrate how the use of control groups became popular in clinical research. Had early physicians only used a control group they would have discovered the futility of blood letting when it came to treating all sorts of diseases. The text highlights the challenging issues involved in the choice of a comparison group for the experimental treatment. Should a researcher use placebos or active drugs? Or if neither is possible, would historical controls or untreated subjects be appropriate? Possible explanations for the placebo effect are also offered.
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 7 — The Control Groups
Cited References
Chalmers I, Toth B. Thomas Graham Balfour's 1854 report of a clinical trial of belladonna given to prevent scarlet fever. The James Lind Library. http://www.jameslindlibrary.org/trial_ records/19th_Century/balfour/balfour_commentary.html Apr 12, 2007.
Food and Drug Administration. Center for Drug Evaluation and Research. http://www. fda.gov/ CDER/GUIDANCE/4155fnl.htm#P222_10018 May 15, 2001.
Gotzsche P. Methodology and overt and hidden bias in reports of 196 double blind trials of non-steroidal antinflamatory drugs in rheumatoid arthritis. Control Clin Trials 1989:10;31–56.
Horwitz R. Complexity and contradiction in clinical trials research. Am J Med 1987:82;498–510.
Hrobjartsson A, Gotzsche P. The controlled clinical trial turns 100 years: Fibiger's trial of serum treatment of diphtheria. Br Med J 1998:317;1243–1245.
Sacks H, Chalmers T, Smith H. Randomized versus historical controls for clinical trials. Am J Med 1982:72;233–240.
Tramer M, Reynolds D, Moore R, et al. When placebo controlled trials are essential and equivalence trials are inadequate. Br Med J 1998:317;875–880.
General References
Beecher H. The powerful placebo. JAMA 1955:159;1602–1606.
Brooks M. 13 things that do not make sense. New Scientist. http://www.newscientist.com/article. ns?id=mg18524911.600 Apr 21, 2007.
Brown W. The placebo effect. Sci Am 1998:278;90–95.
Chalmers I. Comparing like with like: some historical milestones in the evolution of methods to create unbiased comparison groups in therapeutic experiments. Int J Epidemiol 2001:30;1156–1164.
Hrobjartsson A, Gotzsche P. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. New Engl J Med 2001:344;1594–1602.
Lamb G. If placebos work, should doctors use them? Christian Sci Monit Apr 17, 2005:13.
Rothman K, Michels K. The continuing unethical use of placebo controls. New Engl J Med 1994:331;394–398.
Simon R. Are placebo-controlled clinical trials ethical or needed when alternative treatment exists? Ann Intern Med 2000:133;474–475.
Talbot M. The placebo prescription. New York Times Jan 9, 2000:34.
Temple R, Ellenberg S. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1 Ethical. Ann Intern Med 2000:133;455–463.
Wager T, Rilling J, Smith E, et al. Placebo-induced changes in fMRI in the anticipation and experience of pain. Science 2004:303;1162–1167.
Rights and permissions
Copyright information
© 2009 Springer Science + Business Media B.V
About this chapter
Cite this chapter
(2009). The Control Group – Leveling the Playing Field. In: It's Great! Oops, No It Isn't. Springer, Dordrecht. https://doi.org/10.1007/978-1-4020-8907-7_7
Download citation
DOI: https://doi.org/10.1007/978-1-4020-8907-7_7
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)