Skip to main content

Bias Control – A Closer Look at Blinding and Randomization

  • Chapter
It's Great! Oops, No It Isn't
  • 1678 Accesses

There are many uncontrolled factors in clinical studies and, in order to make sound treatment assessments, researchers need to impede their influence. The two pillars of the clinical trial that deter bias are blinding and randomization. Blinding keeps the subjects and researchers honest by concealing the mediation a subject takes and randomization is designed to produce equivalent treatment groups. But blinding isn't fool proof — treatment identification may be exposed to researchers and/or subjects because of the unique action (e.g. dry mouth) of a drug and there are also many examples of deliberate attempts to un-blind clinical studies. Without randomization researchers would decide who gets a new treatment and who gets a control treatment t (e.g. placebo) and those choices would almost assuredly biased a study's results. Allowing treatment assignments to be made by a random process is a major way to overcome that possibility, but, there is no guarantee that randomization has succeeded in creating unbiased treatment groups.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

Chapter 9 — Bias Control

Cited References

  • Bigby M, Gadenne A. Understanding and evaluating clinical trials. J Am Acad Dermatol 1996:34;555–590.

    Article  PubMed  CAS  Google Scholar 

  • Bingel A. Über Behandlung der Diphtherie mit gewöhnlichem Pferdeserum. Deutsch Arch Klin Med 1918:125;284–332.

    Google Scholar 

  • Fisher S, Greenberg R. How sound is the double-blind design for evaluating psychotropic drugs? J Nerv Ment Dis 1993:181;345–350.

    Article  PubMed  CAS  Google Scholar 

  • Gluud L. Bias in clinical intervention research. Am J Epidemiol 2006:163;493–501.

    Article  PubMed  Google Scholar 

  • Greenberg R, Bornstein R, Zborowski M, et al. A meta-analysis of Fluoxetine outcome in the treatment of depression. J Nerv Ment Dis 1994:182;547–551.

    Article  PubMed  CAS  Google Scholar 

  • Hewitt C, Hahn S, Torgerson D, et al. Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals. Br Med J 2005:330;1057–1058.

    Article  Google Scholar 

  • Horgan J. Placebo nation. New York Times Mar 21,1999:15 section 4.

    Google Scholar 

  • Ioannidis J, Anna-Bettina H, Maroudia P, et al. Comparison of evidence of treatment effects in randomized and nonrandomized studies. JAMA 2001:286;821–830.

    Article  PubMed  CAS  Google Scholar 

  • Klotter J. Double blind clinical trials. Townsend Letter for Doctors and Patients. June 2002:27–28.

    Google Scholar 

  • Kodish E, Eder M, Noll R, et al. Communication of randomization in childhood leukemia trials. JAMA 2004:291;470–475.

    Article  PubMed  CAS  Google Scholar 

  • National Cancer Institute. Introduction to clinical trials. www.nci.nih.gov/clinicaltrials/learning/ Oct 12, 2004.

  • Schulz K. Subverting randomization in controlled trials. JAMA 1995:274;1456–1468.

    Article  PubMed  CAS  Google Scholar 

  • Walizer M. Research methods and analysis searching for relationships. New York: Harper&Row, 1978.

    Google Scholar 

General References

  • Altman D. Comparability of randomised groups. Statistician 1985:34;125–136.

    Article  Google Scholar 

  • Altman D, Schulz K, Moher D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001:134;663–694.

    PubMed  CAS  Google Scholar 

  • 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.

    Article  PubMed  CAS  Google Scholar 

  • Day S, Altman D. Blinding in clinical trials and other studies. Br Med J 2000:321;504.

    Article  CAS  Google Scholar 

  • Even C, Siobud-Dorocant E, Dardennes R. Critical approach to antidepressant trials. Br J Psychiat 2000:177;47–51.

    Article  CAS  Google Scholar 

  • Gill T. Blinded by science. Lancet 1994:343;553–554.

    Article  Google Scholar 

  • Gluud L. Bias in clinical intervention research. Am J Epidemiol 2006:163;493–501.

    Article  PubMed  Google Scholar 

  • Gotzsche P. Blinding during data analysis and writing of manuscripts. Control Clin Trials 1996:17;285–290.

    Article  PubMed  CAS  Google Scholar 

  • Horgan J. Placebo nation. New York Times Mar 21,1999:15.

    Google Scholar 

  • Kaptchuk T. Intentional ignorance: a history of blind assessment and placebo controls in medicine. B Hist Med 1998:72;389–433.

    Article  CAS  Google Scholar 

  • Roberts C, Torgerson D. Understanding controlled trials. Baseline imbalance in randomised controlled trials. Br Med J 1999:319;185.

    CAS  Google Scholar 

  • Schulz K, Grimes D. Allocation concealment in randomised trials: defending against deciphering. Lancet 2002:359;614–618.

    Article  PubMed  Google Scholar 

  • Schulz K, Chalmers I, Altman D. The landscape and lexicon of blinding in randomized trials. Ann Intern Med 2002:136;254–259.

    PubMed  Google Scholar 

Download references

Rights and permissions

Reprints and permissions

Copyright information

© 2009 Springer Science + Business Media B.V

About this chapter

Cite this chapter

(2009). Bias Control – A Closer Look at Blinding and Randomization. In: It's Great! Oops, No It Isn't. Springer, Dordrecht. https://doi.org/10.1007/978-1-4020-8907-7_9

Download citation

Publish with us

Policies and ethics