ABSTRACT

The clinical scientist is concerned with answering questions—determining the validity of formally constructed hypotheses. Such scientific information, it is presumed, will benefit humanity in general. The randomized clinical trial also prevents the treatment technique from being modified on the basis of the growing knowledge of the physicians during their participation in the trial. Moreover, it limits access to the data as they are collected until specific milestones are achieved. The conflicting moral demands arising from the use of the randomized clinical trial reflect the classic conflict between rights-based moral theories and utilitarian ones. The argument usually used to justify randomization is that it provides, in essence, a critique of the usefulness of the physician's beliefs and opinions, those that have not yet been validated by a randomized clinical trial. The purpose of the randomized clinical trial is to avoid the problems of observer bias and patient selection.