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Category: Placebo controlled trials. A placebo is an inert substance that looks and tastes like an active drug, which is used in research studies to provide a blinded comparison group for the active drug. In a study of a medical device or a physical intervention, the placebo takes a different form. Placebo controlled trials raise difficult ethical and logistical concerns. Articles are arranged by date with the most recent entries at the top. You can find the theme and closely related categories and other resources at the bottom of this page.
Stats: The stubborn insistence on placebos (June 29, 2007). The patients who volunteer for a randomized trial are sacrificing a great deal of autonomy. They giving up the right to determine which drug they get and they are ceding this authority not to an expert but to a random device. You should not abuse that gift by asking them to participate in a trial where they have a 50% chance of getting a treatment that is known to be inferior. This is especially difficult when one of the choices is a placebo. There is a hot debate about when a placebo arm is ethically acceptable.
Stats: The trouble with apples and oranges (June 25, 2007). I am still working on the details of a presentation for the Kansas City University of Medicine and Biosciences. They want me to talk at lunch during the 2007 Homecoming CME and Reunion weekend. The new title is "Medical Journals - The Trouble with Apples and Oranges."
Stats: When bad control groups happen to good researchers (June 15, 2007). The Kansas City University of Medicine and Biosciences wants me to give a light humorous talk at lunch during the 2007 Homecoming CME and Reunion weekend. Somehow, they provided me with a title for my talk, "Humor, Databases and Grant Proposals: What Strange Bedfellows" which is a fine title, but not the one I would have chosen. I'll talk it over with the organizers, but here's a possible choice: "When bad control groups happen to good researchers".
Stats: The tension between scientific validity and ethical concerns (November 17, 2006). A question on the IRB Forum email discussion group (from RI) centered on the ethical concerns about using a placebo arm in a study involving control of pain. There are scientific reasons why a placebo control group are important, but is it ethical to ask research subjects to possibly endure some greater level of pain in order to achieve certain scientific goals?
Stats: Ethics concerns about a placebo run-in (October 4, 2006). Dear Professor Mean, Some of the trials that our Institutional Review Board looks at have a placebo run-in period. All patients are given a placebo before the start of treatment and anyone who responds well to the placebo is dropped from the trial. What are the ethical ramifications of such a study. You can't disclose the placebo run-in period to the research volunteers because it would defeat the purpose.
Stats: Patients' reactions to finding out they were in the placebo group (May 11, 2005). A lot of people have written a lot of things about the use of placebos in research, but one group that hasn't been heard from nearly enough is the patients themselves. A recently published article has changed that trend.
Stats: Excluding placebo responders (June 25, 2004). I've always been fascinated by the placebo effect and the ethical issues associated with use of placebos in research. A correspondent in the IRBForum email discussion group asked about the recent efforts of drug companies to identify patients who are likely to show a placebo effect and then exclude them from randomized trials.
Stats: Ethics of a placebo group (August 2, 2001). Dear Professor Mean, Some of my colleagues want to use placebos in their research, but I have warned them about the ethical issues surrounding the use of a placebo group. When (if ever) is it ethical to use a placebo group? --Kibitzing Kathy
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This webpage was written by Steve Simon on 2007-06-26, edited by Steve Simon, and was last modified on 2008-07-14. Send feedback to ssimon at cmh dot edu or click on the email link at the top of the page.