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Statistical elements in the design of clinical trial research protocol
WANG Ruiping
Shanghai Medical & Pharmaceutical Journal ›› 2023, Vol. 44 ›› Issue (3) : 65-70.
PDF(1487 KB)
PDF(1487 KB)
Statistical elements in the design of clinical trial research protocol
({{custom_author.role_en}}), {{javascript:window.custom_author_en_index++;}}The design of a clinical trial protocol is the primary aspect of clinical research. A well-written clinical research protocol can clarify the purpose of the research and guide the standardization of clinical trial research. The design of a clinical research protocol is also a scientific and rigorous task and must comply with the statistical requirements of the specifications while meeting the clinical treatment needs. With reference to the Uniform Standards for Reporting of Randomized Controlled Trials (CONSORT) statement, PICO principles and China’s Good Clinical Practice, the clinical study design types were introduced, including statistical elements in clinical study protocol design such as randomization protocols, control settings, replication, blinding, endpoint indicators, analysis sets, data monitoring and management committees, missing data and data filling methods, statistical analysis and subgroup analysis, so as to provide reference for researchers to write clinical study protocols.
clinical trial / research protocol design / statistical elements / subgroup analysis forest plot {{custom_keyword}} /
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王瑞平, 肇辉, 李斌. 随机对照临床试验设计要点和规范[J]. 上海医药, 2022, 43(7): 72-77.
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Whether the association of cardiovascular diseases (CVDs) with dementia differs by sex remains unclear, and the role of socioeconomic, lifestyle, genetic, and medical factors in their association is unknown.We used data from the UK Biobank, a population-based cohort study of 502,649 individuals. We used Cox proportional hazards models to estimate sex-specific hazard ratios (HRs) and 95% confidence intervals (CI), and women-to-men ratio of HRs (RHR) for the association between CVD (coronary heart diseases (CHD), stroke, and heart failure) and incident dementia (all-cause dementia, Alzheimer's Disease (AD), and vascular dementia (VD)). The moderator roles of socioeconomic (education, income), lifestyle (smoking, BMI, leisure activities, and physical activity), genetic factors (APOE allele status), and medical history were also analyzed.Compared to people who did not experience a CVD event, the HRs (95%CI) between CVD and all-cause dementia were higher in women compared to men, with an RHR (Female/Male) of 1.20 (1.13, 1.28). Specifically, the HRs for AD were higher in women with CHD and heart failure compared to men, with an RHR (95%CI) of 1.63 (1.39, 1.91) and 1.32 (1.07, 1.62) respectively. The HRs for VD were higher in men with heart failure than women, with RHR (95%CI) of 0.73 (0.57, 0.93). An interaction effect was observed between socioeconomic, lifestyle, genetic factors, and medical history in the sex-specific association between CVD and dementia.Women with CVD were 1.5 times more likely to experience AD than men, while had 15% lower risk of having VD than men.© 2022. The Author(s).
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