The marriage of clinical trials and clinical decision science

Abstract

Clinical decision science is concerned with rational clinical decisions. All branches of medical research contribute here, but controlled clinical trials of the pragmatic variety carry a particular responsibility. Usually, however, they are not conducted and reported so that they can be used directly as input to a decision analysis. We suggest that the forces of the two methodologies should be united, and point out some areas where this 'marriage' will have a non-trivial impact: choice of end points, style of outcome recording, adaptive designs, and style of result presentation. Special attention is given to the decision-analytic setting of research priorities, the role of utility calculus in quantifying the ethical dilemmas that surround clinical trials, and the use of patient attitude towards outcomes of treatment as a covariate in its own right.