Helsinki discords: FDA, ethics, and international drug trials.
Helsinki discords: FDA, ethics, and international drug trials.
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赫尔辛基的分歧： FDA、伦理学和国际药物试验。
DOI：
10.1016/s0140-6736(08)61936-4
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发表时间：
2009
期刊：
影响因子：
--
通讯作者：
Meslin,EricM
中科院分区：
文献类型：
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作者：
Kimmelman,Jonathan;Weijer,Charles;Meslin,EricM
Since 1964, the Declaration of Helsinki has stood as one of the world’s most authoritative statements on ethical standards for human research. 1 Drafted by the World Medical Association to provide medical researchers with ethical guidance, the Declaration has undergone six major revisions, most recently in October, 2008. 2 For many years the US Food and Drug Administration (FDA) has required that foreign clinical studies supporting applications for drug licensure comply with the Declara tion. However, on Oct 27, 2008, the FDA formally discontinued its reliance on the Declaration and substituted the International Conference on Harmonization’s Guideline for Good Clinical Practice (GCP). 3 The rationale behind the FDA’s action is complex, and no doubt reflects an effort to balance important interests and public-policy goals. Among the FDA’s reasons are the need to assure the quality of foreign data submitted to the agency, a wish to prevent confusion among researchers when the Declaration of Helsinki under goes revision, and a worry that future modifications could “contain provisions that are inconsistent with US laws and regulations”. 3 The FDA’s latest action completes a process begun in 2001 when the agency declined to recognise the 2000 revision, in part due to the Declaration’s restrictive stance on placebo-controlled trials in econ omically developing countries. 4 The practical consequences of the FDA’s current action are unclear because the ruling applies to only a subset of clinical trials—ie, international trials. Moreover, several countries that host such research have regulations that endorse or emulate the Declaration of Helsinki.Nevertheless, at a time when the volume of overseas trials is increasing, 5 the FDA’s new policy is troubling. First, the Declaration of Helsinki has a moral authority that GCP lacks. The Declaration has long been recognised as a leading international ethical standard for research. Whereas the World Medical Association includes 85 national medical societies from every part of the globe, the International Conference on Harmonization consists of only voting members from the USA, the European Union, and Japan. Indeed, the authors of GCP acknowledge the authority of the Declaration of Helsinki when they state that a goal of GCP is “consisten [cy] with the principles that have their origin in the Declaration of Helsinki”. 6 The FDA regulates the largest drug market in the world and we worry that its replacement of the Declaration of Helsinki with a less morally authoritative document may cause others to follow suit, thereby undermining international ethical standards for research. Second, the Declaration of Helsinki has a breadth and depth that GCP lacks. 1 For sure, GCP covers similar topics to the Declaration, but the focus of GCP is regulatory harmonisation, not the articulation of ethical commitments. Careful examination of the two documents reveals several important ethical issues that are addressed in the Declaration about which GCP is silent (panel).
