Optimising the economic efficiency of drug studies.

The cost of the development of a new drug product, from concept and synthesis of a new chemical entity to safety and efficacy testing, to the approval process and postmarketing surveillance, has more than quadrupled in the last 20 years. To amortise these costs, the pharmaceutical industry has taken on international dimensions. These efforts will not be enough. This review outlines many cost-saving and cost-containment suggestions that have been instituted or that need to be instituted in order to bring cost-effective drug therapy to individual patients. As the cost of illness continues to increase worldwide, it is imperative that new and cost-effective medications be developed and brought to worldwide markets. This article considers components of the drug discovery and development processes which are likely to be inefficient and correctable. It further reviews current knowledge about the conduct of different parts of the processes, including different types of clinical trials and proposals that have been made to address these in an efficient manner. Documented and proposed cost-containment measures are presented, using several large scale trials as examples. Particular emphasis is placed on statistical methods and their contribution to either efficiencies or inefficiencies. No facet of the drug/product development should be overlooked in the attempt to reduce costs, from reducing the time it takes to bring a product to market to simple but too-frequently occurring errors, such as failing to have trial material at hand at the optimum time.