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These are the best of times and the worst of times for those involved in the discovery, development, and evaluation of medical therapies. The revolutions in molecular biology, electronic technology, global economics, and the political process offer both promise and peril for all scientists wherever and however they pursue their disciplines. Scientists within the U.S. Food and Drug Administration (FDA) have not been shielded from these cataclysms of dangerous opportunity. Despite the uncertainty about the future roles of the FDA itself, there has never been as much intellectual activity within the Agency directed at understanding the principles and improving the processes by which drugs and other therapies are assessed and approved. Within the Agency, there is growing recognition of the scientific discipline involved in the evaluation of drugs. More science and less art in the evaluation of drug research should be welcomed by everyone working to discover and develop new treatments. Support and involvement of those from every area of biomedical science is needed now for the development of this discipline to proceed apace. Drug evaluation science is more than just the specialized application to the drug development process of well-defined scientific disciplines such as biostatistics, pharmacology, and molecular biology. Membership in one of these or the many other disciplines involved in drug development is necessary but, by itself, insufficient to qualify as a drug evaluation scientist. In essence, the evaluator scientist begins with a detailed understanding of a complex, multidisciplinary process. The practice of the science centers around incessant hypothesis generation and assumption testing. Finally, the logic of and the conclusions reached

Beyond Drug Regulation: The Science of Drug Evaluation