Enhanced Infrastructure for Optimizing the Design and Execution of Clinical Trials and Longitudinal Cohort Studies in the Era of Precision Medicine

Abstract

In 2006, the National Institutes of Health (NIH) launched the Clinical and Translational Science Awards (CTSA) program in order to support an accelerated pace of translational science (from bench to bedside and community, and back), both within and among academic centers. The CTSA program was also developed with an aim of training the next generation of clinical and translational scientists. The CTSA program replaced the previous General Clinical Research Centers program, for which the utilization of resources and infrastructure toward industry-sponsored trials was restrictive and had led to maintenance of both the General Clinical Research Centers and the Clinical Trial Office as dual and often redundant 1 organizations for centralized research support and review processes for NIH-funded vs industry-sponsored studies. CTSA-funded institutions have centralized both laboratory cores for research-based analytics and staff resources for regulatory (Food and Drug Administration [FDA]- and Institutional Review Board [IRB]related) expertise and process improvement. In addition, the CTSA cooperative group and colleagues have developed informatics approaches to enhance recruitment in research studies and facilitated broad adoption of a free electronic data capture system developed previously via NIH funds (REDCap). 2