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: β = 0.842, 0.691 and 0.579, respectively; P < .01. Contract research organization management had a negative effect on trial quality: β = -0.476; P = .013. Research team management had no effect on trial quality: β = 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.