, Volume 64, Issue 2, pp 115-125
Date: 29 Jan 2008

Do we learn the right things from clinical trials?

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Introduction

Starting with what is considered to be the first clinical trial – the 1944 Patulin trial [1] – clinical trials have been seen to represent a transitional state between the medicine of impressions and evidence-based medicine. Clinical trials are not research. As B. Fisher stated: “Like an electron microscope or a flow cytometer, they are mechanisms for conducting research” [2]. In other words, clinical trials are instruments to test hypotheses. They can be carried out for a number of reasons, such as to obtain approval for a new drug, to study a diagnostic tool, to establish differences between two similar diseases, to investigate a mechanism of action, to compare two drugs with a similar indication, among many others.

The planning and execution of modern clinical trials are the result of a series of innovations that have been introduced into their design over a period of almost 100 years. These include the introduction of controls or comparators, a fundamental concept in a c