In the seven years since the sequencing of the human genome, the much anticipated acceleration in the prevention and treatment of human disease has not materialized. In fact, the development of new therapies, drugs and devices has declined markedly.1,2 Paradoxically, “at a time when basic biomedical knowledge is increasing exponentially, the gap between bench discovery and bedside application appears to be expanding.”1 The recognition of this widening gap between basic biomedical discovery and clinical application has stimulated a number of national programs to narrow this gap such as the series of NIH Roadmap initiatives. |
While many of these new programs focus on the clinical and translational components of the continuum between discovery and patient care, the development of novel clinical and translational methodologies has been largely overlooked. As pointed out in the FDA Critical Path Initiative,1,3,4 we urgently need a new “toolkit” – containing refined and new methods for identifying novel translational methodologies, the development of biomarkers, clinical trial design research, ethics research, and community-based research – if we are going to keep pace with the tremendous advances in basic science. Consequently, we propose to modernize our toolkit for clinical and translational science at UK through the activities of the KF-7 Development of Novel Clinical and Translational Methodologies key function. The overall goal of this key function is to refine existing tools and develop new ones that make the process of clinical and translational science itself more efficient and effective and more likely to accelerate the movement of basic science discoveries to tangible improvements in patient care. In so doing, this key function, very much like biostatistics, will permeate, reinforce & amplify the impact of all the other key functions. |
