Decision-making in the development of new drugs.

The main decisions concerning the development of new drugs are taken by the drug producer, the prescriber, the drug regulator and the patient. The decisions taken by each party are different, although their aims are similar--to obtain safer and more effective therapy. These proposals are discussed in relation to antihypertensive drug therapy, but the underlying principles are similar for any therapeutic area. The producer must decide whether to be innovative, to cross-license another manufacturer's preparation, or to manufacture a 'me-too' drug. The prescriber must decide whether to treat the hypertensive patient and, if so, whether to use an established or a new drug. The regulator's decisions are constrained by the laws of the country in which he works and are concerned with safety, quality and efficacy of the product. The final arbiter is the patient, whose decisions are determined more by adverse effects than efficacy.