Barriers and evidence-informed strategies for the high-quality development of drug clinical trials in Anhui Province, central China: A cross-sectional survey.

ObjectiveTo investigate the current status, challenges, and development needs of the drug clinical trial industry in Anhui Province, central China, and to provide empirical evidence to support its high-quality development.MethodsThis cross-sectional study administered a questionnaire survey to 453 practitioners across multiple drug clinical trial institutions in Anhui Province (crude response rate, 63.9%; valid response rate, 62.9%). The survey collected data on demographic characteristics, work-related factors, perceived barriers and facilitators, and job satisfaction. Descriptive statistics, subgroup comparisons with Bonferroni correction, and ordinal logistic regression were used for data analysis.ResultsClinical research coordinators accounted for 32.01% of respondents, whereas biorepository managers accounted for only 0.44%. Respondents with a pharmacy background comprised 41.72%, whereas those with a clinical medicine background accounted for 30.46%. Only 54.30% of respondents reported proficiency in operating electronic data capture systems. The main reported challenges included difficulty recruiting trial participants (77.70%), low public awareness (68.21%), and insufficient self-reported digital literacy among practitioners (48.34%). A total of 90.29% of respondents supported the establishment of clinical trial-related academic programs in higher medical education. Improving professional competency was identified as the most important measure (76.38%), followed by optimizing regulatory systems (12.80%). Overall, 69.09% of practitioners reported satisfaction with their career development.ConclusionClinical trial practitioners in Anhui Province face prominent challenges, including difficulties in participant recruitment, an imbalanced workforce structure across job roles, insufficient digital literacy, and complex management processes. Based on these findings, several evidence-informed directions are proposed: strengthening public education, optimizing talent training, promoting digital infrastructure development, and enhancing regional coordination. These measures may facilitate the high-quality development of drug clinical trials in Anhui Province, central China.