The umbrella trial has received increasing attention in the design of clinical trials for oncology drugs in recent years. This trial design categorizes a single disease into multiple sub-types based on predictive biomarkers or other predictive factors, and simultaneously evaluates the efficacy of multiple targeted therapies. When compared with the traditional drug development model of phase Ⅰ, phaseⅡ, and phase Ⅲ randomized controlled trials, umbrella trials are a more scientifically rigorous trial design that can speed up drug evaluation to address the conflict between numerous untested drugs and diseases with a lack of effective treatment options. This article will focus on the concept, main characteristics, eligibility criteria, design and statistical considerations, ethical considerations, and future directions of umbrella trials, with the aim of providing methodological guidance for the design of clinical trials for oncology drugs.
Objective To investigate the current situation and influencing factors of social phobia in patients with gastrointestinal neoplasms, and to provide evidence for psychological intervention and improving the quality life of patients with gastrointestinal neoplasms. MethodsGastrointestinal neoplasms patients admitted to the Colorectal Cancer Center Ward of West China Hospital, Sichuan University between December 2021 and March 2022 were continuously included. A self-made questionnaire, social phobia behavior professional test scale, and social support rating scale were used to investigate the included patients and analyze the possible influencing factors of social phobia in patients. Results A total of 483 patients were included. Among them, there were 299 males and 184 females. The median score of social support rating scale was 37 (31, 42), with 80.54% of patients received average levels of social support. The median score of social phobia behavior professional test scale was 14 (11, 17), with 98.34% of patients had mild social phobia symptoms and 1.66% had moderate social phobia symptoms. There were statistically significant differences in social phobia behavior professional test scale scores among patients with different levels of education and average monthly income. The results of multiple linear regression analysis showed that the average monthly income was a influencing factor for patients’ social phobia. Conclusions Generally, patients with gastrointestinal neoplasms have mild social phobia. However, patients with fixed income had a higher risk to suffer social phobia were compared to those without income. It is suggested that clinical workers should pay more attention to the mental health of gastrointestinal neoplasms patients and prevent the occurrence of anxiety and phobia.