This paper points out some defects in many existing studies of the effects of drugs on driving, and shows how it is possible to improve them by applying quality assurance (QA) and standardisation approaches. Most of the current research does not estimate the degree of performance impairment, but only shows whether or not specific drugs are impairing. Many empirical studies may contribute flawed data for categorising drug effects on driving performance, and the database as a whole may not be entirely suitable for this purpose. Experts in the field all agree that it is possible and desirable to use standardisation to reduce the variety of research, considering that: (1) the behaviour being investigated must always be related to the actual occurrence of accidents; (2) the conditions for examining the behaviour must correspond to those where drugs and driving are normally combined. Despite several national and international guidelines for the conduct of clinical trials of psychotropic drugs, some general and specific questions about them remain unanswered. The first step to a proposal for internationally consistent methodology was taken at a Workshop in Padova, Italy, in October 1991. Table 1 of the paper gives the outline of the methodology recommended there, which covers subjects, design, performance tests, and statistical methodology.
Abstract