DevelopingChronicDiseaseTherapiesPresentationtothe.ppt

DevelopingChronicDiseaseTherapiesPresentationtothe.ppt

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Developing Chronic Disease Therapies Presentation to the FDA Science Board Robert M Califf MD Director Duke Clinical Research Institute Details in: Health Affairs: 23:77-88; 2004 Key Points Chronic diseases will be (are) the dominant health issue in our society Predicting whether a chronic disease therapy causes net benefit or harm is difficult Biomarkers and imaging are the way to go But mostly as a screen Cannot substitute for clinical outcomes in most circumstances Tremendous inefficiency in clinical trials Life Expectancy Medicare Growth 2002–2030 Medicare enrollment 2002: 40 million 2030: 77 million —N Engl J Med 2001;344:928–31 Worker : beneficiary ratio 2002: 4.0 : 1 2030: 2.3 : 1 2070: 2.0 : 1 — Annual Report to Congress, the Medicare Board of Trustees “The financial status of the fund has deteriorated significantly, with asset exhaustion projected to occur in 2019 under current law compared to 2026 in last year's report.” Medicare will grow much faster than the economy as a whole, increasing from 2.6 percent of the gross domestic product last year to 3.7 percent in 2010, 7.7 percent in 2035 … Projected Medicare costs would exceed those for Social Security in 2024 … The Cycle of Clinical Therapeutics—New Model Principles for Trials Designed to Define Balance of Risk and Benefit of Therapy Treatment effects usually modest Qualitative interactions are uncommon Quantitative interactions common Unintended targets common Long-term vs. short-term effects may differ Combinations are unpredictable Class effect may not be valid Most treatments produce a mixture of benefits and risks Califf and DeMets Circ 2002 Principles of Trials Designed to Elucidate the Balance of Risk and Benefit of Therapies Most beneficial therapies do not save money, but create incremental benefit for incremental cost Applying the results of clinical trials is beneficial Some areas of CV medicine are underserved and therefore lack evidence to guide practice Our current method

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