Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

Use of Placebo in a Trial of Thalidomide for Pediatric Crohn Disease

Use of Placebo in a Trial of Thalidomide for Pediatric Crohn Disease Letters 3. Mérie C, Køber L, Skov Olsen P, et al. Association of warfarin therapy duration In Reply Although there are no specific guidelines for the use after bioprosthetic aortic valve replacement with risk of mortality, of a placebo in clinical trials of patients with Crohn disease, thromboembolic complications, and bleeding. JAMA. 2012;308(20):2118-2125. both the US Food and Drug Administration and the European Medicines Agency have released guidance documents on the choice of the control group, including a decision tree on how Use of Placebo in a Trial of Thalidomide 1,2 to identify the most appropriate one. Both agencies clas- for Pediatric Crohn Disease sify 5 types of control groups: placebo, active treatment, no To the Editor In a double-blind, placebo-controlled, random- treatment, dose-comparison, and external control. ized clinical trial (RCT), Dr Lazzerini and colleagues examined Each type has strengths and weaknesses depending on theeffectofthalidomidevsplaceboinchildrenwithactiveCrohn the scientific question being asked, the intervention being disease refractory to immunosuppressive medications. All im- tested, and the group of participants involved. No one type munosuppressive medications had to be stopped prior to re- of control group is ideal in all situations, and researchers cruitment and only tapering steroids were allowed during the should http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Use of Placebo in a Trial of Thalidomide for Pediatric Crohn Disease

JAMA , Volume 311 (12) – Mar 26, 2014

Loading next page...
 
/lp/american-medical-association/use-of-placebo-in-a-trial-of-thalidomide-for-pediatric-crohn-disease-YihDNbYajy
Publisher
American Medical Association
Copyright
Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2014.1275
pmid
24668111
Publisher site
See Article on Publisher Site

Abstract

Letters 3. Mérie C, Køber L, Skov Olsen P, et al. Association of warfarin therapy duration In Reply Although there are no specific guidelines for the use after bioprosthetic aortic valve replacement with risk of mortality, of a placebo in clinical trials of patients with Crohn disease, thromboembolic complications, and bleeding. JAMA. 2012;308(20):2118-2125. both the US Food and Drug Administration and the European Medicines Agency have released guidance documents on the choice of the control group, including a decision tree on how Use of Placebo in a Trial of Thalidomide 1,2 to identify the most appropriate one. Both agencies clas- for Pediatric Crohn Disease sify 5 types of control groups: placebo, active treatment, no To the Editor In a double-blind, placebo-controlled, random- treatment, dose-comparison, and external control. ized clinical trial (RCT), Dr Lazzerini and colleagues examined Each type has strengths and weaknesses depending on theeffectofthalidomidevsplaceboinchildrenwithactiveCrohn the scientific question being asked, the intervention being disease refractory to immunosuppressive medications. All im- tested, and the group of participants involved. No one type munosuppressive medications had to be stopped prior to re- of control group is ideal in all situations, and researchers cruitment and only tapering steroids were allowed during the should

Journal

JAMAAmerican Medical Association

Published: Mar 26, 2014

References