Management of Clinical Research "Architecture"

¹ Protection Branch, Drugs Directorate, Tunney's Pasture, Ottawa, Canada.
² Drugs Directorate.

There is a need for sound information on the relative safety and clinical effectiveness of new drugs. Such knowledge may be provided by valid answers to questions which arise in applying modern experimental methods to clinical trials. The aim of this paper is to focus attention on such questions particularly as they relate to some principles of the modern statistical design of experiments for obtaining data and drawing sound conclusions from them.

No one set of questions is applicable to all clinical trials. They will vary according to the objectives of the study and special problems which can arise owing to variability over time and place of the test subjects, the observers, and the methods employed.

Assuming that a degree of cognizance is given to the "message" in this paper, the point must be made that whatever is recommended herein is only a small part of the whole discipline of "adequate and well-controlled clinical studies." After protocol design, etc., come the crucial features of appropriate choice and matching of available and willing (largely dependent upon their propinquity) investigators with the type of research problem to be solved.⁸⁷ It is indeed quite distressing to review an exquisitely designed protocol that eventually reaped little more than chaff owing to insufficient, inadequate, or inappropriate monitoring.

We are firmly convinced that in the design stage of clinical trials, representatives from other departments, i.e., marketing, advertising, sales, legal, executive management (time permitting), chief operating hemisphere officer, and/or at least subsidiary president or his delegee, should be part of the expeditious planning team. I say expeditious because important as is design, it is the end result "where it's at" today.

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