Optimizing the Value to Society of Industry-Sponsored Clinical Research

Clinical research, due to its costs and timelines, often stands as the rate limiting step in the translation of the extraordinary advances being made in biology and medicine into health benefits. A substantial portion of clinical research is funded by the pharmaceutical and medical device industries to support market access, market penetration, and reimbursement of products. While private and government funded research supplements this research, there is much that can be done to ensure the industry-funded, product-directed research addresses societal needs optimally. In this talk I will compare the clinical information needs and value equations of regulators, payers, policymakers, providers, and patients. Several aspects of clinical research design that play a role in ensuring efficient addressing of critical needs will be discussed, with examples. Some public policy measures that can impact the efficiency and utility of industry-sponsored trials will be identified.