Iintroduction

The product decision to invest enormous sums in pivotal studies of safety and efficacy of a new treatment should be made when the probability of success has grown to 90% from the 10% on choosing a new molecule. This point can be reached in less than 1000 days after 100 patients for $10 million. For optimal speed, minimal waste resources, enhanced ethics, and maximal information from each subject, the chemistry, toxicology, and clinical studies should not be done en bloc in series, but rather elegantly braided together in a stronger, shorter continuum of data capture, analysis, and utilization to plan the next dose. A clear focus on the goal—a better-quality investment decision—will aim this braid straight to that target with no unraveling of unnecessary studies, with conservation of living subjects, and with maximum decision-critical information per minute. Only three things are needed to achieve this new paradigm of efficiency: clear thinking, an elegant informatics system for all data and users, and a plan based on the relevance diagram of the product decision.

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