When studies in animals predict that a new molecule may be a useful medicine, i.e. effective and safe in relation to its benefits, then the time has come to put it to the test in man.
We devote substantial space to clinical evaluation of drugs because doctors need to be able to scan reports of therapeutic studies to decide whether they are likely to be reliable and deserve to influence their prescribing.
Moreover, most doctors will be involved in clinical trials at some stage of their career and need to understand the principles of drug development.
When a new chemical entity offers a possibility of doing something that has not been done before or of doing something familiar in a different or better way, it can be seen to be worth testing. But where it is a new member of a familiar class of drug, potential advantage may be harder to detect.
Yet these 'me-too' drugs are often worth testing. Prediction from animal studies of modest but useful clinical advantage is particularly uncertain and therefore if the new drug seems reasonably effective and safe in animals it is also reasonable to test it in man: 'It is possible to waste too much time in animal studies before testing a drug in man'.11
From the commercial standpoint, the investment in the development of a new drug can be in the order of £200 million but will be substantially less for a 'me-too' drug entering an already developed and profitable market.
Brodie B B 1962 Clinical Pharmacology and Therapeutics 3:
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