ArticleCurrent medical science2020
Quality Management Model for Phase I Clinical Drug Trials: A Structural Equation Model.
Article in Current medical science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
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
This study aimed to construct a quality management model for phase I clinical drug trials. A cross-sectional survey was conducted and data were collected from 604 respondents at 69 institutions in China engaged in phase I clinical drug trials. Exploratory and confirmatory factor analyses were used to develop the survey tool. Structural equation modeling was used to construct a quality management model for phase I clinical drug trials. The results showed that the final survey tool had good reliability and validity (Cronbach's α=0.938, root mean square error of approximation=0.074, comparative fit index=0.962, and Tucker-Lewis index=0.955). The model included five dimensions: government regulation, industry management, medical institution management, research team management, and contract research organization (CRO) management. In total, 22 measurement items were obtained. The structural equation model indicated government regulation, industry management, medical institution management, and CRO management significantly affected the quality of phase I clinical drug trials (β=0.195, β=0.331, β=0.279, and β=-0.267, respectively; P<0.05). Research team management had no effect on the quality of trials (β=0.041, P=0.610). In conclusion, the model is valuable for identifying factors influencing phase I clinical drug trials and guiding quality management practices.
Indexed as
Identifiers
32681264What 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.