Pre-Trial Phase
In order to have a successful clinical trial, the trial must be carefully designed. The successful design of a clinical trial starts long before the trial itself does. During the critical pre-trial design phase, SEOPF statisticians are available to help with:
input on trial design
analysis plan development
protocol development
sample size and power calculations
patient randomization
CRF development and review
statistical programming utilizing the SASŪ system
development of reports and tables to meet sponsor guidelines
During the Trial
While a clinical trial is being conducted, AFDT statisticians are available to:
perform interim data analysis
provide consultation on statistical issues that arise during the trial
Post-Trial Phase
During the post-trial phase, AFDT statisticians contribute to the successful completion of the trial by:
merging databases from single or multiple sources utilizing the SASŪ system
programming for statistical analysis
generating summary reports, tables and graphs
preparing electronic files, with documentation, in SASŪ data sets
performing data analysis as described in the protocol
performing additional data analysis that may be requested by the sponsor
preparing clinical and statistical reports
preparing manuscripts and presentations