Application of adaptive designs--a review.

A literature search has been performed to review applications of the adaptive design methodology based on the combination test or conditional error function approach. Some features of the 60 papers identified are summarized, e.g., the specific methodology used, calendar year, country, impact factor of the journal, number of planned and performed stages respectively, stopping for futility boundaries, type of adaptations and others. A selection of the ten recent publications in journals with the highest impact factors is discussed in more detail. Most applications up to now aim at sample size reassessment, the majority of papers is coming from Germany. Although we found that renowned journals allow for sufficient space to present the new statistical methodology in all its necessary details, the general impression is that the presentation of the adaptive designs methodology in applied papers has to be improved. Education and development of standards could help to achieve this.