Seminars

The objective of a clinical trial may be either to target the maximum tolerated dose or minimum effective dose,
 or to find the therapeutic range, or to determine the optimal safe dose to be recommended for confirmation, 
or to confirm efficacy over control in a Phase III clinical trial. This clinical goal is usually determined by the clinicians
 from the pharmaceutical industry, practicing physicians, key opinion leaders in the field, and the regulatory agency. 
Once agreement has been reached on the objective, it is the statistician's responsibility to provide the appropriate 
design and statistical inferential structure required to achieve that goal. There is a plenty of available designs on 
statistician's shelf. The greatest challenge is their implementation. I exemplify this in three case studies.