Analysis on nauthentic data in new drug clinical trials.
- Author:
Ping LIU
- Publication Type:Journal Article
- MeSH:
Clinical Trials as Topic;
standards;
Data Collection;
standards;
Drug Evaluation;
Drug Industry;
Humans;
Quality Control
- From:
China Journal of Chinese Materia Medica
2014;39(24):4873-4876
- CountryChina
- Language:Chinese
-
Abstract:
The authenticity and accuracy of data in clinical trials is extremely important. Any inauthentic data may affect the result of a clinical trial, and cause great loss. In our opinion, inauthentic data includes not only man-made spurious data, but also inaccurate data objectively formed. In this article, the features of inauthentic data are described, how to distinguish inauthentic data is discussed, and the causes of this kind of data are analyzed and concluded, which include: subjective intervention on the result of clinical trials, differentiation of the GCP knowledge level between different investigators, misunderstanding of the protocol, et al. And finally we propose that scientific training to investigators and other involved personnel and quality control during the course of data collection should be strengthened to prevent the occur of inauthentic data in clinical trials.
