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Topic:
Randomized Control Trials
Faculty:
Graham Nichol
Renee Stapleton
Session Goals:
Describe the various types of “intervention trials” (clinic, community, etc.).
Examine the strengths of trials.
Examine the practical difficulties of conducting clinical trials.
Definitions:
Observational Studies – observational studies, where the investigator does not try to change anything but rather observes how things naturally occur, serves as a contrast to intervention trials.
Intervention – Any form of action that is under study, for example: 1) taking a drug, 2) changing an individual’s diet, 3) brief counseling sessions, 4) new clinic-wide information systems, 5) community-wide programs to increase the use of bicycle helmets.
Intervention Trials – Using some variation of an experimental design that includes a comparator group that does not receive intervention, these studies strive for the most reliable inference regarding the effects of intervention.
Randomized Control Trials (RCTs) – the emblematic, most rigorous type of intervention trial.
Materials Provided for Pondering:
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Califf, Robert M. MD; DeMets ,David L. PhD Principles From Clinical Trials Relevant to Clinical Practice: Part I. Circulation. 106(8):1015-1021, August 20, 2002.
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Califf, Robert M. MD; DeMets ,David L. PhD Principles From Clinical Trials Relevant to Clinical Practice: Part II. Circulation. 106(9):1172-1175, August 27, 2002.
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DeMets ,David L. PhD; Califf, Robert M. MD Lessons Learned From Recent Cardiovascular Clinical Trials: Part I. Circulation. 106(6):746-751, August 6, 2002. (get on PubMed!)
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DeMets ,David L. PhD; Califf, Robert M. MD Lessons Learned From Recent Cardiovascular Clinical Trials: Part II. Circulation. 106(7):880-886, August 13, 2002.
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Wittes J. Sample Size Calculations for Randomized Controlled Trials. Epidemiol Rev, Jul 2002 ;24 :39 - 53
Suggested Reading:
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Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials, 3rd Ed. New York: Springer, 1999.
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Hulley & Cummings, Designing Clinical Research, Chapter 11
Last Updated: 06/30/05
Contact the webmaster at: cmunch@u.washington.edu
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