The growth of clinical trials has emerged as an indispensable foundation and major source of advances in medicine and human health. Their proliferation, size, complexity, and cost have engendered several recent consensus conferences; the reports arising reflect broad concern about the future sustainability of the current model of clinical trials.1,2 These initiatives have also variously called for greater efficiency, increasing end point validity and relevance, more adaptable and flexible designs, and better return on the investment of diverse stakeholders.
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