Methodologic reporting requirements for clinical trials Reply

Plotkin Stanley A.

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Methodologic reporting requirements for clinical trials Reply

机译：临床试验的方法学报告要求回复

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Morel et al. [1] report data in mice showing induction of higher B cell responses by a 3-component acellular pertussis vaccine (DTaP3) than by a 5-component vaccine (DTaP5). These data are interesting, although the position of a WHO working group on acellular vaccines concluded that “in the absence of unequivocal data for correlation with protection in humans, the [intranasal mouse] model may not be appropriate for comparison of different products and the interpretation of superiority/inferiority between them” [2].

机译：莫雷尔等。 [1]报告的小鼠数据显示，用3组分无细胞百日咳疫苗（DTaP3）比用5组分疫苗（DTaP5）诱导更高的B细胞应答。这些数据很有趣，尽管WHO脱细胞疫苗工作组的立场得出结论：“在缺乏明确的数据与人类保护相关的情况下，[鼻内小鼠]模型可能不适用于比较不同产品和解释。他们之间的优势/劣势” [2]。

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《Vaccine》 |2011年第52期|共1页
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Plotkin Stanley A.;
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Pertussis; Sweden; B cells;

机译：百日咳;瑞典;B细胞;

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1. Methodologic reporting requirements for clinical trials Reply [J] . Plotkin Stanley A. Vaccine . 2011,第52期

机译：临床试验的方法学报告要求回复
2. Methodologic reporting requirements for clinical trials: Advancing the science today and tomorrow [J] . Poland Gregory A. . Vaccine . 2011,第32期

机译：临床试验的方法学报告要求：推动当今和未来的科学发展
3. Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States [J] . Ina Jazic, Olivia M Shopshear, Jocelyn Ulrich, BMJ Open . 2017,第9期

机译：临床试验透明度：重新评估行业对美国临床试验注册和报告要求的遵守情况
4. The development of the evaluation methodology of the methodological quality of scientific publications about clinical trials and requirements for the information system for its automation [C] . Stanislav S. Otstavnov, Andrey N. Briko, George R. Khachatryan, 2018 Ural Symposium on Biomedical Engineering, Radioelectronics and Information Technology . 2018

机译：关于临床试验的科学出版物的方法学质量评估方法论的发展及其对自动化信息系统的要求
5. Hypersensitivity Adverse Event Reporting in Clinical Cancer Trials: Barriers and Potential Solutions to Studying Severe Events on a Population Level [D] . ?Eldredge, Christina 2020

机译：临床癌症试验中的超敏反不良事件报告：障碍和潜在的解决方案，用于研究人口水平的严重事件
6. Methodological quality and reporting of ethical requirements in clinical trials [O] . M. Ruiz-Canela, J. de Irala-Estevez, M. A. Martinez-Gonzalez, 2001

机译：方法质量和临床试验中伦理要求的报告
7. Methodological quality and reporting of ethical requirements in clinical trials [O] . Ruiz-Canela, M. (Miguel), Irala, J. (Jokin) de, Martinez-Gonzalez, M.A. (Miguel Ángel), 2001

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8. Coordinating Center Models Project: A Study of Coordinating Centers in Multicenter Clinical Trials. XIV. Enhancement of Methodological Research in the Field of Clinical Trials [R] . 1979

机译：协调中心模型项目：多中心临床试验中的协调中心研究。十四。加强临床试验领域的方法论研究

Methodologic reporting requirements for clinical trials Reply

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