Use and Abuse of Placebo in Clinical Trials

被引:0
作者
D. J. Lyons
机构
[1] The Earlsfort Centre,Irish Medicines Board
[2] Earlsfort Terrace,undefined
来源
Drug information journal : DIJ / Drug Information Association | 1999年 / 33卷 / 1期
关键词
Placebo; Clinical trials;
D O I
暂无
中图分类号
学科分类号
摘要
The double blind, placebo controlled clinical trial (PCT) has been for many years the most rigorous and compelling method for demonstrating the efficacy of new therapeutic agents. Despite this, concerns have been expressed in the medical literature that there is misuse of the PCT and that such misuse is being driven by the requirements of the pharmaceutical industry and pharmaceutical regulatory authorities. In this paper a brief general overview of the advantages and disadvantages of the PCT is provided and comments are made on its use for pharmaceutical registration and regulatory purposes.
引用
收藏
页码:261 / 264
页数:3
相关论文
共 15 条
[1]  
Way W(1979)Controlled trials—planned deception. Editorial Lancet. 1 534-535
[2]  
Simmons J(1984)Placebo controls New Eng J Med. 311 413-414
[3]  
Rothman KJ(1978)The continuing unethical use of placebo controls Med Ethics. 4 172-178
[4]  
Michels KB(1994)Confusion over the use of placebo in clinical trials New Engl J Med. 331 394-398
[5]  
Collier J(1995)Surgery as placebo. A quantitative study of Bias Br Med J. 311 821-822
[6]  
Beecher HK(1961)Government viewpoint of clinical trials of cardiovascular drugs JAMA. 176 1103-1107
[7]  
Temple R(1989)Placebos prompt new protocols for AIDS drug tests Med Clin North Am. 73 495-509
[8]  
Barinaga M(1988)Denial of effective treatment and poor quality of clinical information in placebo controlled trials of ondansetron for postoperative nausea and vomiting: a review of published trials Nature. 335 485-846
[9]  
Aspinall R(1995)Another view of active controlled clinical trials Br Med J. 311 844-485
[10]  
Goodman N(1991)Trials to assess equivalence: The importance of rigorous methods Control Clin Trials. 12 474-39