ArticleFrontiers in pharmacology2023
China's drug clinical trial institution record-keeping system: Qualification requirements for PI are the key.
Article in Frontiers in pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed.
- Current Status and Construction Requirements of Drug Clinical Trial Institutions in Sichuan Province in China.Therapeutic innovation & regulatory science · 2026Review
- Risk of bias among Chinese-language randomized controlled trials on Chinese herbal medicine included in meta-analyses published in 2021-2022: A cross-sectional study.Integrative medicine research · 2026Article
- Implementation status and quality improvement strategies of the record-filing system for drug clinical trial institutions in Sichuan Province.Frontiers in medicine · 2026Article
- An ideal portrait of the professional competence of clinical research nurses: A qualitative study.Asia-Pacific journal of oncology nursing · 2025Article
- Quality of Drug Clinical Trials in China: A Mixed Methods Research.Journal of evidence-based medicine · 2025Article
- Expert consensus on clinical research nurse management in China.Asia-Pacific journal of oncology nursing · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.