Using Clinical Trials to Strategic Advantage is a new DR Report from Decision Resources, Inc., that explains how clinical trials can be invaluable sources of strategic and competitive advantage. Clinical trial results drive internal decisions regarding portfolio priorities and resource allocation; they are often among the most important factors in merger, acquisition, financing, and strategic alliance decisions; and, particularly for smaller and start-up companies, they are the primary determinant of share price and market valuation. This report evaluates three distinct but closely interrelated topics -- the factors contributing to overall clinical trial success; well-planned clinical trial end points; and the appropriate use of a uniquely robust clinical trial design, the placebo-controlled trial -- that provide frameworks for exploring the singular opportunities clinical trials present for reaching business goals.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000303/DECISION ) Components of Clinical Trial Success
The clinical research phase is the longest and most costly segment of the drug development process, and is therefore the focus of intensive efforts to streamline it and improve its probabilities of success. Every development program should include a formal Clinical Development Plan (CDP) that maps out the clinical pathway to be pursued in the quest for regulatory approval and that is firmly grounded in the Prospective Package Insert (PPI). However, the findings of this report show that the CDP and the PPI are the most frequently ignored components in clinical development programs.
Clinical Trial End Points -- A Key Strategic Decision
Successful pharmaceutical manufacturers are increasingly using clinical trial end points to differentiate their products in attractive market segments that are already crowded with similar products. In selecting end points for clinical trials, trial strategists must keep in mind the multiple audiences for efficacy data: corporate management, scientific and academic communities, regulatory authorities, and the prescribers/users market. Because the choice of end points is critical to conducting successful clinical trials, obtaining regulatory approval, and securing market share, this choice must be regarded as a key strategic decision.
Controversy Surrounds Placebo-Controlled Trials
One of the most powerful tools available to many clinical development programs is the placebo-controlled clinical trial. In recent years, however, the use of such trials has spawned considerable controversy: medical ethicists have adopted diametric positions on the ethical acceptability of placebo- controlled trials. At the crux of the controversy is the Declaration of Helsinki, with advocates on both sides basing their arguments on discrepant interpretations of its statements on the use of "best current therapy" in medical research.
Using Clinical Trials to Strategic Advantage is a DR Report published by Decision Resources, Inc. This report is available for $2,400.00.
Decision Resources, Inc., is a world leader in research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets. Founded as a subsidiary of Arthur D. Little, Inc., the company has provided strategic information services for 30 years, assessing international pharmaceutical and health care industry trends. Visit Decision Resources at http://www.dresources.com/.
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