Quality of phase I clinical drug trials: Influence of organizational management factors

What is known and Objective Focusing on the tolerance and pharmacokinetics of new drugs, phase I clinical drug trials are characterized by high risk, poor compliance and management difficulties. High-quality clinical drug trials ensure subjects' safety while extending new drug research and development. Many studies have examined micro-level concerns of trial design and implementation rather than macro-level factors. Accordingly, we evaluated the quality of phase I clinical drug trials (trial quality) and analysed the influence of organizational management factors from a macro-level perspective. Methods We surveyed staff at clinical trial institutions engaged in phase I clinical drug trials in China using convenience sampling. We employed a five-point Likert-scale questionnaire, comprising five items on phase I clinical drug trial quality and items on organizational management factors. Data from 604 questionnaires were analysed. We utilized a logistic regression model to estimate the influence of organizational management factors on trial quality, using individual demographic factors as controlling variables. Results and discussion The trial quality score was 3.81, which indicates that substantial improvement is required. Government regulation, industry management and medical institution management had a positive effect on trial quality:beta = 0.842, 0.691 and 0.579, respectively;P beta = -0.476;P = .013. Research team management had no effect on trial quality:beta = 0.325;P = .141. What is new and Conclusion This study is the first to model the influence of organizational management factors on the quality of phase I drug trials involving different organizations from a macro-perspective. Efforts are needed to help research teams take responsibility for trial quality and to correct the negative impact of contract research organizations on trial quality.