International Regulatory Standards for the Qualitative Measurement of Deep Brain Stimulation in Clinical Research

IF 1.7 4区 哲学 Q2 ETHICS
I. Stevens, F. Gilbert
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引用次数: 2

Abstract

Deep brain stimulation (DBS) has progressed to become a promising treatment modality for neurologic and psychiatric disorders like epilepsy and major depressive disorder due to its growing personalization. Despite evidence pointing to the benefits of DBS if tested on these personalized qualitative metrics, rather than randomized-control trial quantitative standards, the evaluation of these novel devices appears to be based on the latter. This study surveyed the presence of this trend in the national regulatory guidelines of the prominent DBS researching countries. It was found that two governing bodies, in the European Union and Australia, acknowledged the option for qualitative measures. These findings support further development of national regulatory guidelines, so the neuroscientific community developing these neurotechnologies can better understand the impact their treatments have on patients.
临床研究中脑深部刺激定性测量的国际监管标准
脑深部刺激(DBS)由于其日益个性化,已发展成为一种治疗癫痫和重性抑郁症等神经和精神疾病的有前途的治疗方式。尽管有证据表明,如果在这些个性化的定性指标而不是随机对照试验的定量标准上进行测试,DBS的益处,但对这些新型设备的评估似乎是基于后者。本研究调查了DBS主要研究国家的国家监管指南中存在的这一趋势。调查发现,欧洲联盟和澳大利亚的两个理事机构承认可以选择采取质量措施。这些发现支持国家监管指南的进一步发展,因此开发这些神经技术的神经科学界可以更好地了解其治疗对患者的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
3.50
自引率
7.70%
发文量
30
审稿时长
>12 weeks
期刊介绍: The Journal of Empirical Research on Human Research Ethics (JERHRE) is the only journal in the field of human research ethics dedicated exclusively to empirical research. Empirical knowledge translates ethical principles into procedures appropriate to specific cultures, contexts, and research topics. The journal''s distinguished editorial and advisory board brings a range of expertise and international perspective to provide high-quality double-blind peer-reviewed original articles.
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