Is the Controlled Clinical Trial Sufficient as a Drug Technology Assessment?

Journal/Book: Journal of Social and Administative Pharmacy. 1989; 6: 117-126.

Abstract: In this article, drugs are viewed as a technology and, as such, comparable to other technologies developed and assessed in today's societies. The concepts of technology and technology assessment are described and applied to drugs. The question is raised whether today's basic prerequisite for the registration of a new drug, i.e. the controlled clinical trial (CCT) is adequate enough to provide data enabling the prediction and prevention of drug problems.As evidence by problems appearing with the use of drugs after marketing, the answer is: No. This article demonstrates how the lack of knowledge is a consequence of the basic premises and critical traits of the CCT. It is necessary to develop other theoretical models and other methodological designs for drug technology assessment. At present, the authors are not able to offer a new recipe to be followed by those conducting a trial, but some essential points for another approach to drug technology assessment are outlined.

Keyword(s): Drugs (as a technology)

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