HHS Strategic Plan, Fiscal Years 2007–2012 (Strategic Plan). Pace and Success of Research

11/22/2015

In recent years, rapid advances in the biomedical sciences have raised expectations of similar progress in the development of products for the prevention and treatment of serious illnesses. Despite huge strides to decipher the intricacies of human biology, medicine today remains, to an unfortunate degree, an attempt to balance the risks of treatments against their uncertain potential to cure. Physicians earnestly attempting to provide the best treatments, along with their patients—who may be suffering from any of a host of debilitating, even fatal, diseases—are too often left waiting for treatments that are expensive and, ultimately, may not work for them. Compounding these problems is the fact that the number of new drugs and other treatments approved each year for use in the United States is steadily dropping, in no small part because scientists test new discoveries using outdated and inefficient tools and techniques. The result is a slow, expensive process, one that produces fewer and fewer treatments that can be approved as safe and effective. This process also leaves consumers on their own to grapple with the question marks of treatment and a short list of prevention options.

One of HHS’s primary strategies for reversing this trend is through the FDA Critical Path Initiative (CPI). The CPI identifies and prioritizes the most pressing medical product development problems and the greatest opportunities for rapid improvement in public health benefits. The goal is to stimulate the development of powerful new scientific and technical tools—such as proven biomarkers, innovative clinical trial designs, simulation models of physiology and disease processes, and manufacturing quality assessment methods—capable of rapidly predicting the safety, effectiveness, and quality of new medical products. Development of these tools will be based on an understanding of the most successful practices as well as the failures, roadblocks, bottlenecks, and missed opportunities along the way.

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