关键词: 药物临床试验, 眼科学

Abstract: Objective To understand the implementation characteristics of industry-sponsored drug clinical trials for eye diseases in China. Design Retrospective observational study. Participants 201 drug clinical trials for eye diseases registered in the drug clinical trials registration and information disclosure platform of National Medical Products Administration from 2014 to 2021 were included. Methods The database and the related indexes were described and analyzed. Main Outcome Measures The completion rate of trials, the time-consuming for the starting-up and completion of trials. Results By the end of December 2021, the completion rate of 201 trials was 50.75%. The completion rate of bioequivalence studies (BE), phase I, phase II, phase III, phase IV trials was 85.71%, 58.21%, 39.39%, 43.06%, 71.43% respectively. The completion rate targeting age-related macular degeneration, macular edema and diabetes retinopathy was 57.45% (27/47), 46.88% (15/32), 63.16% (12/19) respectively. There were 12 trials in suspension/termination status. The main reasons were the clinical trial approval permission expired (4/12), protocol related issue (3/12), and adverse events (3/12). The median time-consuming for the starting-up of all trials was 4.28 (3.00, 6.02) months, wherein the BE, phase I, phase II, phase III, phase IV trials was 4.07 (0.30, 5.17), 3.87(3.00, 6.30), 4.90(2.10, 6.50), 4.63(3.20, 5.87), 3.50(0.93, 4.90) months respectively. 65.17% trials completed the first subject enrollment within 6 months after approved. The median time-consuming for the completion of all trials was 14.80 (4.07, 23.83) months wherein the BE, phase I, phase II, phase III, phase IV trials was 2.80(1.33, 4.73), 8.27(2.03, 16.53), 24.08(6.81, 49.18), 20.57(12.87, 27.95) and 31.73(24.51, 35.33) months respectively. Conclusions From 2014 to 2021, the drug clinical trials targeting fundus diseases were well implemented among industry-sponsored drug clinical trials for eye diseases in China.  The main reasons of trials suspension/termination were the clinical trial approval permission expired, protocol related issue (3/12), and adverse events. More than half of the trials have completed the first subject enrollment within six months after approval. The time-consuming for the staring-up and completion of trials was about 4 and 15 months respectively. (Ophthalmol CHN, 2023, 32: 98-102)

Key words: drug clinical trials, ophthalmology