Finding a successful approach

According to ICH guidelines a Statistical Analysis Plan should be prepared prior to unblinding the clinical study. The aim of the Statistical Analysis Plan is to minimise bias by clearly stating the proposed methods of dealing with protocol deviators, early withdrawals, missing data, and the way(s) in which anticipated analysis problems will be handled as well as many other possible issues.

The Statistical Analysis Plan will usually include sample layouts for tables and listings to be produced. Therefore preparation of a Statistical Analysis Plan is a key component in the conduct of a rigorous clinical trial and requires a statistician with both formal statistical training and significant experience in the pharmaceutical industry.

At Statistical Revelations we have experienced statisticians who have been involved in the preparation of Statistical Analysis Plans in most therapeutic areas and all phases of clinical research.