Increasingly, purchasers and providers of healthcare will become accountable for their decisions and care provision. This review discusses the climate and need for outcomes data. It outlines opportunities to obtain these data and highlights a number of issues which need to be addressed in ensuring outcomes have their desired impact, namely improving healthcare. Towards a perfect clinical trial submission. Phase III confirms the findings of Phase II and should avoid ambiguity by assigning only a few end points per study.
End points ought to be clinically relevant.
Safety must be demonstrated in a sufficient number of patients from as broad a population base as possible.