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CLINICAL PHARMACOLOGY 2003 (PART 6)

We must be daring and search after Truth; even if we do not succeed in finding her, we shall at least come closer than we are at present (Galen AD 130-200) 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 • Types of trial: design, size •. | SECTION I Evaluation of drugs in man We must be daring and search after Truth even if we do not succeed in finding her we shall at least come closer than we are at present Galen AD 130-200 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 Types of trial design size Meta-analysis Pharmacoepidemiology Experimental therapeutics As the number of potential medicines produced increases the problem of whom to test them on grows. There are two main groups healthy volunteers and volunteer patients plus rarely nonvolunteer patients . .