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Wow — and we thought that the decade from the first to the second edition was one of rapid change. The changes in the pharmaceutical industry in the last decade, from the second to this third edition, have been even more enormous. For example, the industry and all of its thinking have become global so that planning from the very beginning of a new drug to its marketing are done on an international basis. The regulatory authorities have made great strides in harmonization so that there are fewer small and time consuming differences from one country to another. Computer power has permitted an increased level of statistical sophistication in analyses and in improved communication over the internet and intranet. Now one designs clinical trials that are adaptive and thus provide flexibility and also raise interesting new statistical issues of validity. Proving superiority over placebo is becoming less important and trials that show equivalence with (or superiority to) a known effective medication are thus more common and important.
This book then tries to convey the excitement of the pharmaceutical industry to an audience including those who work there on the industry side or the regulatory authorities who review the work of the industry and wish to learn about a different area, to those who may work there in the future and wish to learn more about the industry before making that decision, and to those who just wish to understand more about the role of statistics in this research and these companies. These chapters are written by those on the front lines in the industry and at the regulatory agencies. The views of those who originate the statistics and those who then evaluate the analysis are both here. While their roles may give these statisticians different viewpoints, their goals are the same: see that studies are designed to prove safety and efficacy and good manufacturing and find new medications that are marketable while weeding out the chemical candidates that have some defect. The answers vary with different classes of drugs and this variety is also illustrated in this volume.
We the editors express our thanks to the authors of these chapters who have recorded their knowledge and experience to make it easier for others to achieve the same level with fewer hurdles. The sophistication of the authors’ thinking has been a blessing to the editors.
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