This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (10)  • Contact me when this article is cited  Related Content  • Related letters  • Similar articles in this journal  Topic Collections  • Medical Practice  • Medical Ethics  • Asthma  • Statistics and Research Methods  • Randomized Controlled Trial  • Immunology  • Allergy  • Alert me on articles by topic  Social Bookmarking   What's this?

The Case of Asthma Clinical Trials

Arch Intern Med. 2002;162:1673-1677.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

THE ETHICS of placebo-controlled clinical trials has generated considerable controversy in recent years. Critics, often citing the Declaration of Helsinki, have argued that use of placebo controls is unethical in trials of medications to treat conditions for which proven effective treatments exist. Defenders of placebo-controlled trials contend that the alternative of clinical trials that compare active treatments without placebo controls are often subject to serious methodological weaknesses. In the present article we develop a middle-ground position on the ethics of placebo-controlled trials, which is applied to recent clinical trials of treatments for asthma. Questions are raised about 3 recent placebo-controlled asthma trials on the grounds that the scientific questions that these trials were designed to answer did not require use of placebo. However, use of placebo controls in initial trials of investigational treatments is defended, provided that patient volunteers randomized to placebo are not exposed to serious risks of irreversible . . . [Full Text of this Article]

BACKGROUND


THE ETHICAL DEBATE

TYPOLOGY OF PLACEBO-CONTROLLED TRIALS

PLACEBO-CONTROLLED TRIALS IN ASTHMA
Trials of Combination Therapy

Comparison of 2 Dosing Regimens

Can Informed Consent Justify Placebo Controls?

Initial Trials of Investigational Agents

CONCLUSIONS


CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

RELATED LETTERS

Continued Need for Placebo in Many Cases, Even When There Is Effective Therapy
Robert J. Temple and Robert Meyer
Arch Intern Med. 2003;163(3):371.
EXTRACT | FULL TEXT  

Continued Need for Placebo in Many Cases, Even When There Is Effective Therapy
Franklin G. Miller and Andrew F. Shorr
Arch Intern Med. 2003;163(3):373.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Ethical Assessment of Clinical Asthma Trials Including Children Subjects
Coffey et al.
Pediatrics 2004;113:87-94.
ABSTRACT | FULL TEXT  

Continued Need for Placebo in Many Cases, Even When There Is Effective Therapy
Miller and Shorr
Arch Intern Med 2003;163:373-373.
FULL TEXT  

Continued Need for Placebo in Many Cases, Even When There Is Effective Therapy
Temple and Meyer
Arch Intern Med 2003;163:371-371.
FULL TEXT