RADICAL CHANGES IN AN R&D PARADIGM: CHALLENGING THE FUNDAMENTAL ASSUMPTIONS SURROUNDING CLINICAL TRIAL STRUCTURES

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Abstract

♦ The pharmaceutical industry is in crisis, with rising costs and falling productivity. The prescription is radical, not incremental, change.

♦ Almost two thirds of all trials may be conducted outside the US in the near future; Latin America, central and eastern Europe, and Asia-Pacific are alternatives for site and clinical operations.

♦ The traditional study design fixes the sample size in advance, analyzing efficacy after all subjects have been enrolled and evaluated; adaptive designs monitor efficacy data as they accrue at convenient intervals to make important decisions concerning the future course of the study.

♦ Electronic data capture (EDC) is not just a new technology; it is about process and a radical new way of thinking about clinical trials.

♦ An effective tool, "Lessons Learned," provides a structured process for teams to share experiences and target areas for improvement, as well as identify project successes.

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