Change of Regulatory Requirement on Cohort Grouping and Endpoint Seting for Intervertebral Fusion Device Clinical Trial.
- Author:
Guo XIAOLEI
- Publication Type:Journal Article
- MeSH:
China;
Clinical Trials as Topic;
standards;
Cohort Studies;
Endpoint Determination;
Humans;
Research Design;
standards;
Spinal Fusion;
instrumentation
- From:
Chinese Journal of Medical Instrumentation
2015;39(4):279-281
- CountryChina
- Language:Chinese
-
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.
