The GCRC encourages all investigators to consult the Biostatistician prior to submitting a protocol to the Scientific Advisory Committee. In particular, the aspects that are considered are:

• Hypothesis
• Sample Size Justification
• Power Determination
• Analysis Plan

These statistical considerations are all integral to the scientific merit of a clinical study; therefore, they are carefully considered by the committee. A consultation with the statistician beforehand may save you a revision.