Change of Regulatory Requirement on Cohort Grouping and Endpoint Seting for Intervertebral Fusion Device Clinical Trial / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 279-281, 2015.
Article
in Chinese
| WPRIM
| ID: wpr-265643
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Reference Standards
/
Research Design
/
Spinal Fusion
/
China
/
Cohort Studies
/
Clinical Trials as Topic
/
Endpoint Determination
Type of study:
Etiology study
/
Incidence study
/
Observational study
/
Risk factors
Limits:
Humans
Country/Region as subject:
Asia
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2015
Type:
Article
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