Statistics in clinical trials

Statistics play an essential part throughout any clinical trial, from planning, conduct, interim analysis and final analysis and reporting. The statistician devises the randomisation schedules. Advice on sample size; criteria for measuring treatment differences and analysis of response rates are all the responsibility of the statistician. Time to an event of interest is often used as an endpoint for evaluation of therapies in clinical trials. Time to recurrence of disease, duration of complete remission, and overall survival are examples. The data are shown in the form of survival curves. Analysis (interim and final) are the responsibility of the study statistician. The statistician will also be the link for a trial with the Independent Data Monitoring Committee.

>>>> The role of the Trial Coordinator >>>>