FDA advises on adaptive trials, simulations

The FDA describes concerns and considerations in the draft guidance on adaptive clinical trials released last week. The regulator says that trial simulations performed prior to a study can help evaluate the design options and the clinical scenarios that might take place when the study is actually conducted. It finds that simulations can be "an important planning tool in assessing the statistical properties of a trial design and the inferential statistics used in the data analysis." Content guidance is included for reporting trial simulations. Draft guidance