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Background and Objectives: Multi-regional clinical trials (MRCTs) are an efficient drug development strategy for eliminating drug lag in East Asian countries. In planning MRCTs according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use E17 guideline, it is expected that East Asian populations with relatively similar ethnicity can be pooled as one population. However, evidence supporting this assumption is limited. This study aimed to investigate population/regional differences considering influencing factors among East Asian regions using MRCT data as a research model. Methods: A retrospective analysis was conducted to determine the efficacy of two drugs, asenapine, a schizophrenia drug, and tadalafil, a dysuria drug for benign prostatic hyperplasia, using MRCT data from Japan, Korea, and Taiwan. First, predictive factors and effect modifiers were evaluated. Then, population/regional differences were evaluated using multivariate regression models, with the interaction term Region-by-Treatment group and adjustment for influencing intrinsic/extrinsic factors. Results: Among the 4 outcomes for the two drugs, no significant population/regional differences were detected (P > 0.05) by the adjusted regression models. The effect modifiers, such as pretreatment drug status or concurrent diseases, were common among countries. Conclusions: No significant population/regional efficacy differences were found for the two drugs among the three regions. This finding supported the possible applicability of the region pooling strategy for MRCTs in East Asia, emphasizing the benefits of exploring ethnic difference/influencing factors at an early stage to design further confirmatory studies. However, further evidence for various drugs should be accumulated. [ABSTRACT FROM AUTHOR]

Prior research has indicated a correlation between the birth season and life expectancy; however, many of these studies did not sufficiently account for comorbidities. In this comprehensive investigation, we aimed to meticulously explore the association between the birth month and life expectancy, giving due consideration to comorbidities. We used a robust dataset derived from Taiwan's National Health Insurance Research Database (2000-2013), which allowed us to conduct a thorough examination. We divided our participants into four groups based on their season of birth: spring, summer, autumn, and winter. Propensity score matching was used to ensure an equitable distribution of demographic and clinical characteristics across the groups. Propensity scores were computed using logistic regression. Our model incorporated a broad range of demographic factors and comorbidities, providing rigorous adjustment for potential confounders. Our findings revealed a significantly increased risk of all-cause mortality among individuals born in spring, even after stringent adjustment for demographic factors and comorbidities. People born in spring demonstrated a 1.05-fold increase in the risk of all-cause mortality, with a hazard ratio of 1.05 and a 95% confidence interval of 1.01-1.09. Our study provides compelling evidence that helps understand the potential long-term impacts of a person's birth season, which acts as a proxy for pregnancy / early-life environmental exposure, on life expectancy. These findings underscore the crucial need for additional research to illuminate the underlying biological and environmental mechanisms linking the birth season and lifespan of a person. The elucidation of these links could guide the development of innovative health promotion and disease prevention strategies that are tailored to an individual's birth season., (© 2024. The Author(s).)

Background: A previous study in Japan found that monthly mean K index values were related to the monthly number of male, but not female, suicides. Correlations between geomagnetic disturbances and suicide/depression have also been reported in countries such as Canada, South Africa, Finland, Australia, Russia, and Japan. We have previously shown that stronger geomagnetism is linked to a higher standardized mortality ratio for suicide. To date, however, no published studies have reported the correlation between geomagnetic disturbances and suicide attempts in Taiwan., Methods: Data on the monthly number of suicide attempts in Taiwan from January 1997 to December 2013 were obtained. We performed a multivariable analysis, with the number of suicide attempts as the response variable and monthly Kp10 index, F10.7 index, sulfur dioxide, carbon monoxide, ozone, fine particulate matter (PM2.5), temperature, humidity, unemployment rate, and cosmic rays as the explanatory variables., Results: The multivariable analysis showed that Kp10 index, temperature, humidity, unemployment rate, and cosmic rays were associated with the number of male suicide attempts and that Kp10 index, F10.7 index, carbon monoxide, temperature, humidity, and unemployment rate were associated with the number of female suicide attempts., Conclusion: This is the first article reporting statistically significant relationships between the monthly number of male and female suicide attempts and the monthly mean Kp10 value in Taiwan., Competing Interests: The authors declare no conflict of interest