Article: [Change of Regulatory Requirement on Cohort Grouping and Endpoint Seting for Intervertebral Fusion Device Clinical Trial].
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation
2015 Volume 39, Issue 4, Page(s) 279–281
Abstract: Combining technical requirement from main international administration and status quo of China administration, current regulatory requirement on clinical trail of conventional intervertebral fusion devices has been simplified. Cervical, thoracic and ... ...
Abstract | Combining technical requirement from main international administration and status quo of China administration, current regulatory requirement on clinical trail of conventional intervertebral fusion devices has been simplified. Cervical, thoracic and lumbar cases can be grouped into the same cohort, and primary endpoints are mainly based on imageology rather than clinical score. This is an attempt to rationally lessen industrial burdensome. |
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MeSH term(s) | China ; Clinical Trials as Topic/standards ; Cohort Studies ; Endpoint Determination ; Humans ; Research Design/standards ; Spinal Fusion/instrumentation |
Language | Chinese |
Publishing date | 2015-07 |
Publishing country | China |
Document type | English Abstract ; Journal Article |
ISSN | 1671-7104 |
ISSN | 1671-7104 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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