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. 2023 Mar 2:14:1052977.
doi: 10.3389/fphar.2023.1052977. eCollection 2023.

China's drug clinical trial institution record-keeping system: Qualification requirements for PI are the key

Nanqu Huang  1 , Wendi Huang  1 , Yong Luo  1 , Juan Huang  2   3
Affiliations

China's drug clinical trial institution record-keeping system: Qualification requirements for PI are the key

Nanqu Huang et al. Front Pharmacol. .

Abstract

It has been 3 years since China implemented new management regulations for drug clinical trial institutions in December 2019, the most important of which is to change the qualification recognition of drug clinical trial institutions into record-keeping system. The original intention of the institution record-keeping system was to solve the shortage of clinical trial resources in China, effectively expand the number of clinical trial institutions, and effectively alleviate the contradiction between medical treatment and scientific research. After implementing the record-keeping system, although these goals have been achieved to a certain extent, there are still areas worthy of optimization and improvement. Therefore, we evaluated the new process, in particular the requirements, in order to see what possible barriers in the record-keeping system of institutions. We find that the requirements for principal investigator (PI) qualifications are the key to the record-keeping system. This reflects the shift of Chinese regulators' supervision of clinical trials to supervision of the ability to conduct clinical trials. However, the ambiguity of the definition of PI qualification has hindered implementation of the record-keeping system and reduced the release of clinical trial resources.

Keywords: clinical trial; clinical trial management; drug clinical trial institution; principal investigator; record-keeping system.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
From qualification recognition to record-keeping system: Differences between the clinical trial institution qualification recognition and the record-keeping system.
FIGURE 2
FIGURE 2
The new regulations require that PIs have participated in more than three clinical trials, but the regulations do not explain much about the types of clinical trials. And changes in the number of clinical trial institutions after the implementation of the record-keeping system.
See this image and copyright information in PMC

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