Over-regulation of clinical research: a threat to public health.
Over-regulation of clinical research: a threat to public health.
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临床研究过度监管：对公共健康的威胁。
DOI：
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发表时间：
2005
期刊：
影响因子：
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通讯作者：
C. Warlow
中科院分区：
文献类型：
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作者：
C. Warlow
临床研究越来越受到研究伦理委员会和研究与开发办公室的监管，这些办公室正在应对社会和政治压力，以及欧洲和国家的新立法，其中一些仍在制定中。由此产生的官僚主义、费用和混乱给临床研究和临床护理带来了不可逾越的障碍。仍然可能的研究将只在大型组织中进行，甚至可能存在严重的偏见。解决办法是向公众提供信息和寻求帮助，并与病人团体建立联盟。患者的损失远远大于临床研究人员，如果临床合格，他们可以更容易地追求临床医生而不是研究人员的职业生涯。
Clinical research is subject to increasing regulation by research ethics committees and research and development offices which are responding to social and political pressures, as well as to new legislation, both European and national, some of which is still being worked out. The resulting bureaucracy, expense and confusion are putting insuperable hurdles in the way of clinical research and clinical care is compromised. What research is still possible will only be done in large organisations and may even be seriously biased. The solutions are to inform and seek the help of the public and to forge alliances with patient groups. Patients have far more to lose than clinical researchers who, if clinically qualified, can more easily pursue a fulfilling career as clinicians rather than researchers.