Pharmacovigilance: A Worldwide Master Key for Drug Safety Monitoring: Some Additional Information

This study has some limitations, one of which is its small sample size (Indian medical journals and clinical trials) for analysis. Another limitation here was difficulty in knowing the time of intervention by statisticians, whether he/she has contributed from the start of the clinical trial (design phase) or only during analysis of results. Another limitation may be under-reporting of the role of statistician. In this study, Bonferroni correction was used for adjustment of multiple endpoints. This method of adjustment becomes less reliable, as the number of endpoints increase.