Crossing the research valleys of death: the University of Pittsburgh approach.

Bridging the valley of death” is a phrase that has been used in nonhealth-related disciplines to describe the fundamental challenge of applying research and development advances to operations.1 However, the “valley of death” metaphor is equally appropriate to describe the two major gaps in the translational research continuum: (1) the translation of laboratory discoveries to human subjects and (2) the translation of the resulting evidence to clinical and public health practice and policy.2,3 As one of the initial 12 academic health centers to receive a Clinical and Translational Science Award (CTSA) from the National Institutes of Health (NIH) in 2006, the University of Pittsburgh is part of a growing national consortium (24 institutions in 18 states as of September 2007) on the forefront of developing and evaluating new research models as a means of bridging these valleys. The intent of the CTSA program—an outgrowth of NIH’s well-publicized Roadmap for Medical Research— is to transform how clinical and translational research is done and, thus, to improve how efficiently and effectively biomedical advances reach the individual patient and the population as a whole. NIH has expressed the significance and urgency of this plan: “Over the years, clinical research that helps discover mechanisms of disease, prevention, diagnosis, or treatment has become more difficult to conduct. Yet the exciting discoveries we are currently making require us to conduct even more efficiently the complex clinical studies needed to make rapid medical progress and to further inform our basic science efforts. This is undoubtedly the most challenging, but critically important, area identified through the NIH roadmap process.”4 Strategies employed by industry to meet the “valley of death” challenge include the development of interdisciplinary research programs, infrastructure, interfaces with user communities, observation and data access partnerships, and continuous evaluation processes.1 In addition to adopting these strategies, the biomedical research community must develop strategies to overcome other barriers in order to more effectively translate research findings into healthcare practice.5 Among these barriers are the complex organizational structures of traditional academic health centers, cultures that do not foster collaboration, a shortage of translational investigators to bridge the two major gaps, the absence of mechanisms to facilitate transdisciplinary research, inadequate financial support, and regulatory impediments to clinical research. With $83.5 million in CTSA funding over a 5-year period, the University of Pittsburgh has established a Clinical and Translational Science Institute (CTSI) to serve the dual purposes of: (1) integrating existing programs with innovative new clinical and translational science initiatives under a common umbrella and (2) creating an awareness and understanding—initially among members of the biomedical research/ healthcare community but eventually among the general public as well—of the tangible benefits to health practice that can be realized from clinical and translational research. A primary CTSI focus is to develop, nurture, and support a cadre of highly trained clinical and translational scientists by implementing comprehensive educational and training programs. Other goals include (1) fostering a multidisciplinary, team-based approach to research (such as through an online resource for linking investigators and clinicians from throughout the University’s six health sciences schools and the University of Pittsburgh Medical Center (UPMC)); (2) providing needed resources (for example, research facilitators to serve as a single point of access for investigators to tap into CTSI’s growing array of programs and services); and (3) developing community and industry partnerships not only to draw patients, particularly those from underserved communities who might benefit most from the experience, into clinical research but also to foster the development of novel technologies that could result from such efforts. In all, CTSI embraces 10 core areas of development covering aspects of research from the basics of study design to technology transfer and entrepreneurship. During the recently completed first year of funding, two initiatives began to emerge from CTSI’s Novel Clinical and Translational Methodologies Core, which is designed to serve as an incubator for CTSI-sponsored research that can broadly affect translational research and clinical practice. Each initiative addresses one of the two valleys of death. One involves the adaptation of innovative computer software for diagnostic purposes; the other lays the groundwork for broad public participation in research and clinical trials. Addressing the first valley of death, the Diamond Program illustrates the value of multidisciplinary collaboration to apply emerging bioinformatics technologies to the improvement of clinical practice. Diamond is an open-source software architecture jointly created by Intel and Carnegie Mellon University (both CTSI Screenshot of the MassFind application built on the OpenDiamond platform (Figure provided by M. Satyanarayanan, PhD).