Synopsis

This chapter is about evidence-based drug therapy.

New drugs are gradually introduced by clinical pharmacological studies in rising numbers of healthy and/or patient volunteers until enough information has been gained to justify formal therapeutic studies. Each of these is usually a randomised controlled trial where a precisely framed question is posed and answered by treating equivalent groups of patients in different ways.

The key to the ethics of such studies is informed consent from patients, efficient scientific design and review by an independent research ethics committee.The key interpretative factors in the analysis of trial results are calculations of confidence intervals and statistical significance.The potential clinical significance needs to be considered within the confines of controlled clinical trials.This is best expressed by stating not only the percentage differences, but also the absolute difference or its reciprocal, the number of patients who have to be treated to obtain one desired outcome.The outcome might include both efficacy and safety.

SYNOPSIS (CONTINUED)

Surveillance studies and the reporting of spontaneous adverse reactions respectively determine the clinical profile of the drug and detect rare adverse events. Further trials to compare new medicines with existing medicines are also required.These form the basis of cost-effectiveness comparisons.

Topics include:

• Experimental therapeutics ■ Ethics of research

• Rational introduction of a new drug

• Need for statistics

• Meta-analysis

• Pharmacoepidemiology

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