'first in man': the politics and ethics of women in clinical drug trials
'first in man': the politics and ethics of women in clinical drug trials
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DOI：
10.1057/palgrave.fr.9400055
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发表时间：
2002-01-01
期刊：
影响因子：
1.8
通讯作者：
Corrigan, DR
中科院分区：
文献类型：
--
作者：
Corrigan, DR
在药理学领域，男性身体传统上被视为生物学标准。此外，对未出生胎儿危险的担忧意味着，直到最近，“有生育能力的妇女”通常被排除在大多数临床药物测试的早期阶段之外。因此，在I期试验期间测试的大多数药物最初是在健康男性志愿者中进行的。在随后对病人进行药物试验的阶段，妇女的代表性仍然很低。因此，一些为妇女开的药物后来被发现缺乏疗效，妇女比男子更容易遭受药物不良反应。在临床药物试验的早期阶段将妇女排除在外的做法现已取消，目前正在妇女身上进行更广泛的药物试验。本文探讨了不同的政治和伦理立场，通过制药业，药品监管机构，药理学家，妇女团体和患者活动家的排斥和纳入妇女在临床药物试验。
Within the world of pharmacology, the male body has traditionally been taken as the biological norm. Coupled with this, concern about danger to the unborn foetus has meant that, until very recently, 'women of childbearing potential' were routinely excluded from most of the early phases of clinical drug testing. Consequently, most drugs tested during Phase I trials were initially carried out on healthy male volunteers. During subsequent phases when drugs were tested on patients, women remained largely under-represented. As a result, some drugs prescribed for women have later been discovered to be lacking in efficacy, and women are more likely to suffer adverse drug reactions than men. The exclusion of women during the early phases of clinical drug trials has now been lifted and drugs are currently being more widely tested on women. This paper examines the differing political and ethical positions adopted by the pharmaceutical industry, drug regulators, pharmacologists, women's groups and patient activists in relation to the exclusion and inclusion of women in clinical drug trials.