Design of the Collaborative AtoRvastatin Diabetes Study (CARDS) in patients with type 2 diabetes
Calhoun HM, et al. Design of the Collaborative AtoRvastatin Diabetes Study (CARDS) in patients with type 2 diabetes. Diabetic Medicine 2002; 19:201-211.
Office for Human Research Protections Determination Letter, Available at
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45 CFR 46 Subpart A (Code of Federal Regulations) 1991, generally referred to as the Common Rule.
45 CFR 46 Subpart A (Code of Federal Regulations) 1991, generally referred to as the Common Rule.
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The guidance states: HHS provides for waiving or altering elements of informed consent under certain conditions. FDA has no such provision because the types of studies which would qualify for such waivers are either not regulated by FDA or are covered by the emergency treatment provisions (sec. 50.23) See http://www.fda.gov/oc/ohrt/irbs/appendixe.html.
The guidance states: "HHS provides for waiving or altering elements of informed consent under certain conditions. FDA has no such provision because the types of studies which would qualify for such waivers are either not regulated by FDA or are covered by the emergency treatment provisions (sec. 50.23)" See http://www.fda.gov/oc/ohrt/irbs/appendixe.html.
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Deception in the pursuit of science
Wendler D, Miller FG. Deception in the pursuit of science. Archives of Internal Medicine 2004;164:597-600.
Does a placebo run-in or a placebo treatment cell affect the efficacy of antidepressant medications?
Trivedi MH, Rush H. Does a placebo run-in or a placebo treatment cell affect the efficacy of antidepressant medications? Neuropsychopharmacology 1994;11:33-43.
Does elimination of placebo responders in a place-bo run-in increase the treatment effect in randomized clinical trials? A meta-analytic evaluation
Lee S et al. Does elimination of placebo responders in a place-bo run-in increase the treatment effect in randomized clinical trials? A meta-analytic evaluation. Depression and Anxiety 2004;19:10-19.
