丛集性头痛临床试验设计 2022 指南评述及进一步建议

The Journal of Headache and Pain Pub Date : 2024-03-07 DOI:10.1186/s10194-024-01732-3

Ioana Medrea, Stewart J. Tepper, Donliang Wang, Paul G. Mathew, Mark Burish

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引用次数: 0

摘要

最近发布了丛集性头痛临床试验的新指南。我们对这些新指南表示欢迎，并对试验方法提出了更多的注意事项。我们介绍了非劣效性试验，以克服使用安慰剂的伦理问题，并讨论了试验招募方面的问题。我们强调了最近发布的丛集性头痛试验指南中可能存在的问题和需要考虑的解决方案。

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Commentary on 2022 guidelines on clinical trial design in cluster headache and further suggestions

New guidelines for cluster headache clinical trials were recently published. We welcome these new guidelines and raise additional considerations in trial methodologies. We present non-inferiority trials to overcome ethical issues with placebo use, and additionally discuss issues with trial recruitment. We highlight some possible issues and solutions to be considered with the recently published cluster headache trial guidelines.

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The Journal of Headache and Pain

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