对照试验中的基本问题。

Basic problems in controlled trials.

作者信息

Burkhardt R, Kienle G

出版信息

J Med Ethics. 1983 Jun;9(2):80-4. doi: 10.1136/jme.9.2.80.

DOI:10.1136/jme.9.2.80

PMID:6876102

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1059346/

Abstract

On the basis of critical discussions which have taken place in recent years in the Federal Republic of Germany, certain methodological, ethical and legal problems arising in relation to controlled trials are discussed. Because of methodological inconsistencies inherent in the experimental approach, the efficacy of a drug must in any case be judged by physicians. This leads to major ethical and even--at least in Germany--legal problems which impose considerable limits on the feasibility of controlled trials in Germany. Editor's note: This paper is written at the invitation of the journal, following the considerable controversy on the ethics of clinical trials in the European Journal of Clinical Pharmacology (8-11). A critical commentary follows the paper with a short response from the authors and a further response from the commentator.

摘要

基于近年来在德意志联邦共和国所进行的批判性讨论，探讨了与对照试验相关的某些方法学、伦理和法律问题。由于实验方法本身存在方法学上的不一致性，药物的疗效无论如何都必须由医生来判断。这引发了重大的伦理问题，甚至在德国还引发了法律问题，这些问题对德国对照试验的可行性施加了相当大的限制。编者注：本文是应该期刊邀请撰写的，此前《欧洲临床药理学杂志》（8 - 11）就临床试验伦理问题引发了相当大的争议。本文之后是一篇批判性评论，以及作者的简短回应和评论者的进一步回应。