The role of the clinical and translational science awards program in improving the quality and efficiency of clinical research.

Recognizing the need to increase the efficiency and quality of translating basic discovery into treatment and prevention strategies for patients and the public, the National Institutes of Health (NIH) announced the Clinical and Translational Science Awards (CTSAs) in 2006. Academic health centers that competed successfully for these awards agreed to work as a consortium and in cooperation with the NIH to improve the translation process by training the next generation of investigators to work in interdisciplinary teams, developing public-private partnerships in the movement of basic discovery to preclinical and clinical studies and trials, improving clinical research management, and engaging with communities to ensure their involvement in shaping research questions and in implementing research results. The CTSAs have addressed the crucial need to improve the quality and efficiency of clinical research by (1) providing training for clinical investigators and for bench researchers to facilitate their participation in the clinical and translational research environment, (2) developing more systematic approaches to clinical research management, and (3) engaging communities as active participants in the design and conduct of clinical research studies and trials and as leaders in implementing health advances that are of high importance to them. We provide an overview of the CTSA activities with attention to these three areas, which are essential to developing efficient clinical research efforts and effective implementation of research results on a national level.

Reaping the benefits of biomedical research: partnerships required.

Reaping the benefits of investments in biomedical research can be achieved most efficiently through active collaboration among industry, academia, government, and nonprofit organizations. The National Institutes of Health (NIH) are exploring multiple ways in which to increase the efficiency of the translational process. Investigators involved in the NIH-funded Clinical and Translational Science Awards are developing public-private partnerships, addressing the barriers to collaboration, training the next generation of interdisciplinary team-oriented researchers, and producing open-source tools for collaboration. NIH is engaging with industry through the Foundation for the NIH and the Small Business Innovation Research Awards.

Response to: "Rescuing the NIH before it is too late".

We, the directors of the 27 NIH institutes and centers, wanted to respond to the points made by Andrew Marks in his recent editorial. While we appreciate that the scientific community has concerns, the current initiatives and directions of the NIH have been developed through planning processes that reflect openness and continued constituency input, all aimed at assessing scientific opportunities and addressing public health needs.

Executive summary of the Strategic Plan for National Institutes of Health Obesity Research.

The Strategic Plan for National Institutes of Health (NIH) Obesity Research is intended to serve as a guide for coordinating obesity research activities across the NIH and for enhancing the development of new efforts based on identification of areas of greatest scientific opportunity and challenge. Developed by the NIH Obesity Research Task Force with critical input from external scientists and the public, the Strategic Plan reflects a dynamic planning process and presents a multidimensional research agenda, with an interrelated set of goals and strategies for achieving the goals. The major scientific themes around which the Strategic Plan is framed include the following: preventing and treating obesity through lifestyle modification; preventing and treating obesity through pharmacologic, surgical, or other medical approaches; breaking the link between obesity and its associated health conditions; and cross-cutting topics, including health disparities, technology, fostering of interdisciplinary research teams, investigator training, translational research, and education/outreach efforts. Through the efforts described in the Strategic Plan for NIH Obesity Research, the NIH will strive to facilitate and accelerate progress in obesity research to improve public health.

Consultations on patients with venous or arterial diseases.

Advances in vascular biology and drug development, as well as improved interventional techniques, are yielding multiple new treatments for patients with venous and/or arterial thrombosis. Hematologists who are providing consultations for these patients often participate in a multidisciplinary approach to provide optimal care. New anticoagulants, simplified and validated tests for detecting vascular disease, and improved interventional procedures can all reduce the morbidity and mortality that result from venous and arterial thrombosis. In this chapter, different aspects of the diagnosis and treatment of these disorders are addressed by a hematologist, an expert in vascular medicine, and a vascular surgeon. The key to the prevention and treatment of venous and arterial thrombosis is anticoagulant and antiplatelet therapy. In Section I, Dr. Charles Francis, a hematologist with expertise in thrombosis and hemostasis, describes the clinical trials that have resulted in the approval of newer anticoagulants such as fondaparinux and the thrombin- specific inhibitors. He also reviews the clinical trials that have shown the efficacy of the new oral anticoagulant ximelagatran. Although currently under study primarily for the prevention and treatment of venous thrombosis, these anticoagulants are likely to undergo evaluation for use in arterial thrombosis. Peripheral arterial disease (PAD), which affects as many as 12% of individuals over the age of 65 years, provides a diagnostic and therapeutic challenge to physicians across multiple subspecialties. Dr. William Hiatt, a specialist in vascular medicine, discusses in Section II the epidemiology and manifestations of PAD, the best ways in which to diagnose this disorder and determine its severity, and the most appropriate pharmacologic treatment. In Section III, Dr. Mark Jackson, a vascular surgeon, describes interventional procedures that have been developed or are under development to treat arterial thrombosis. He also reviews the status of inferior vena caval filters that are retrievable.