A key tenet of comparative effectiveness research is that it should be conducted in real-world health care settings. This article addresses a basic question: What is the capacity of the clinical research enterprise to conduct such studies? We argue that the clinical trial system is already at capacity and will not be able to absorb large amounts of comparative effectiveness research without diverting resources from other needs. We propose a federally funded national clinical research infrastructure that would increase comparative effectiveness research capacity by encouraging community-based clinicians and their patients to participate in trials.
Despite the great promise of immunization and recent progress in immunizing children throughout the developing world, a global crisis in vaccine R&D, supply and delivery is faced. This article reviews how the global US6 billion dollars vaccine market is structured and its attractiveness to vaccine suppliers, the international two-tiered pricing system in which high-income countries generate about 82% of vaccine revenues but represent only 12% of the doses, the impact of schedule divergence as high-income and developing countries introduce different vaccines, the role of the US government, and possible approaches to ameliorate the crisis.
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