Bridge the Gap: the need for harmonized regulatory and ethical standards for post-marketing observational studies
Bridge the Gap: the need for harmonized regulatory and ethical standards for post-marketing observational studies
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弥合差距：上市后观察研究需要统一的监管和道德标准
DOI：
10.1002/pds.4269
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发表时间：
2017
影响因子：
2.6
通讯作者：
Dreyer N
中科院分区：
文献类型：
--
作者：
Urushihara H;Parmenter L;Tashiro S;Matsui K;Dreyer N
药品安全问题不分国界。因此，解决安全性问题可能需要监管机构和上市许可持有人（MAH）之间的全球协调努力，以得出可靠的结论。监管机构与申办上市后非干预性研究的MAH共同负责确定研究目标和设计。他们的共同责任包括将研究什么以及如何检索数据，以确保监管决策所需的适当研究质量。上市后观察性研究需要一个协调的框架和伦理标准，这一点得到了广泛的认可，但即使在美国、欧盟和日本（即所谓的国际协调会议（ICH）地区）也一直缺乏。最近更新的国际医学科学组织理事会《涉及人类健康相关研究的国际道德指南》进一步澄清了知情同意的规定和研究伦理委员会的作用。然而，如果不纳入立法结构，这些准则的未来影响是不确定的。这种不协调导致伦理审查和参与者知情同意的框架复杂且不确定，导致监管上市后观察性研究的许多效率低下。审查了在3个地区监管机构主持下进行的上市后观察性研究的监管框架，重点关注伦理要求和提高效率的机会。
Drug safety issues do not respect national borders. Hence, addressing a safety question may necessitate globally coordinated efforts between regulatory authorities and market authorization holders (MAHs) to draw reliable conclusions. Regulatory authorities have shared responsibility with MAHs sponsoring postmarketing nonintervention studies in determining study goals and design. Their shared accountabilities include what will be investigated and how the data will be retrieved to ensure appropriate study quality required for regulatory decision making. The need for a harmonized framework and ethical standards for postmarketing observational studies is well recognized but has been lacking even among the United States, European Union, and Japan, which are so‐called International Conference on Harmonisation (ICH) regions. A recent update of the Council for International Organizations of Medical Sciences International Ethical Guidelines for Health‐Related Research Involving Humans provides further clarification on provisions for informed consent and the role of research ethics committees. However, without incorporation into legislative structures, the future impact of these guidelines is uncertain. This lack of harmonization leads to a complex and uncertain framework for ethical review and for participant informed consent, resulting in numerous inefficiencies in the regulatory postmarketing observational studies. The regulatory frameworks for postmarketing observational studies conducted under the auspices of regulatory agencies in the 3 regions are reviewed, with a focus on ethical requirements and opportunities for efficiencies.