<< Previous Section | < Previous Page | Next Page > | Next Section >> Case: Asthma Comparison Asthma is a serious chronic problem in pediatrics. New drugs being developed for asthma need to be tested in children. This study (an actual study) compared Beclomethasone (established therapy) with a new steroid that we will call NUSTER and placebo. Subjects were recruited from ages 12-16 and were required to have had asthma for at least 6 months and to have used steroids in the last 30 days, signifying serious shortness of breath. The subjects were randomized to 4 groups and treated for 12 weeks: Beclomethasone bid, NUSTER 100 ?g bid, NUSTER 200 ?g bid, and placebo. Subjects would use albuterol, another standard agent, as needed. The main outcome measure was FEV1, a measure of ability to take deep breaths. The study showed that all of the steroid doses were statistically equal and better than placebo, where FEV1 deteriorated. Ten percent of the active treatment subjects and 44% of the placebo subjects had to discontinue the study because of shortness of breath. The study was done in doctors' offices using a commercial IRB. This study was published and used to support the introduction of NUSTER. Was this an ethical study? Was a placebo control justified If the subjects were children? If the subjects were adults? Seven ethical requirements for clinical research as delineated by Emanuel et al are: scientific value scientific validity fair subject selection favorable risk/benefit ratio independent review informed consent respect for enrolled subjects Discuss this study with respect to each of these. Nathan, RA et al; Ann Allergy Asthma Immunol 2001; 86: 203-10 Miller, FG, Storr AF; Chest 2002; 121:1337-42 << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 3 Quick Links Ethics and Study Design Introductory Ethics Design Appropriate Risk to Benefit Ratio Selection of Subject Populations Cases Bibliography Chapter 3 Download (PDF)