Abstract:Objective To analyze the influence of Maslows hierarchy of needs theory on the compliance of subjects in early drug clinical trials, in order to provide basis for improving the management quality of drug clinical trial. Methods A total of 120 healthy subjects who participated the drug clinical trial in a level-A tertiary hospital were selected as the study subjects, including the control group from February to April 2022 (n=60, adopting routine guidance) and the observation group from May to August 2022 (n=60, adopting guidance based on Maslows hierarchy of needs theory). The awareness rate of the relevant contents of the test, the accuracy rate of the return visit time, and the satisfaction of the subjects were compared between two groups. 〖JP2〗Results The awareness rates of the subjects in the observation group on drug knowledge and dietary regulations were better than those in the control group (95.00% vs 81.67%, 96.67% vs 86.67%, P＜0.05), and there was no statistical difference in the awareness rate of exercise requirements between the two groups (98.33% vs 88.34%, P＞0.05). Compared with the control group, the accuracy rate of return visit time in the observation group increased (93.33% vs 80.00%, χ²=6.007, P＜0.05). There was no statistically significant in satisfaction between the two groups (100.00% vs 93.33%, χ²=2.328, P＞0.05). Conclusion Taking Maslows hierarchy of needs theory as a starting point, analyzing the needs of healthy subjects in early clinical trials, combining with the characteristics of clinical trials and meeting the needs of healthy subjects at all levels, can improve their compliance and make drug clinical trials more humanized.