ABSTRACT

This chapter reflects on some manifestations of uncertainty in the design and conduct of clinical research. It focuses on the randomized clinical trial (RCT), generally regarded as the gold standard for the evaluation of therapeutic agents. The purpose of the RCT is to resolve certain types of uncertainties. The RCT is designed to test the null hypothesis. Mathematically, it is impossible to prove the null hypothesis unless one can demonstrate the equivalence of therapies A and B in the entire universe of patients having disease D. The chapter illustrates the gravity of the problems that may be encountered in communications with patient-subjects; in appreciation of these problems several commentators have found it necessary to propose radical revisions of our traditional understandings of medical ethics in the interests of conducting certain types of RCTs.