Developing a quality indicator system for pediatric clinical trials management of research centers in China: a...

Pediatric clinical trials face many challenges that hinder the development of safe and effective pediatric drugs. Enhancing risk control and management quality of pediatric clinical trials in research centers is essential to address these challenges. While existing studies focus on risk management from the perspective of sponsors, research specifically addressing risk management strategies in research centers is limited. There is a lack of systematic exploration and expert consensus on risk-based management system of pediatric trials for institutions. This study seeks to fill this gap by developing a risk assessment index system designed to enhance the management quality of pediatric clinical trials in research centers. The system is built upon a theoretical framework that integrates insights from experts across various domains of pediatric clinical trials.

The Delphi-analytic hierarchy process method was used for expert consultation to develop a risk assessment index system in pediatric clinical trials management of research centers. The questionnaire was distributed to 20 experts with extensive experience in pediatric clinical trials. These experts were selected from various regions and work units across China. Experts with more than 5 years of working experience and bachelor degree or above were included for consultation. The mean value, proportion of experts with full marks, and variation coefficient of important score and feasibility score of the indicators were applied to include the indexes. The analytic hierarchy process was used to investigate the weight of each indicator.

The consultation outcomes exhibited good response rate and credibility, the experts' positive coefficients were 100% and 95%, respectively, and the authoritative coefficients were 0.885 and 0.892. The final quality management indicator system for research centers consisted of four primary, sixteen secondary, and thirty-two tertiary indicators. Protocol design and subject protection accounted for the highest weight of 0.3741 and 0.3148 respectively in the index system, and next came process management and data collection of 0.1879 and 0.1232 in quality management of pediatric clinical trials.

This study develops a systematic expert consensus on a risk-based quality system tailored to the management of pediatric clinical trials in domestic research centers. The framework identifies critical risk indicators in the management process, providing a potential reference for quality control and internal audits within pediatric clinical trial research centers in China. However, further research is required to assess its practical implementation and adaptability to diverse trial conditions.