NIH, FDA and the pharma/biotech industry are working together to drive breakthrough changes in the collection, management and dissemination of clinical data and to promote harmonization and effectiveness of collaborations between stakeholders in clinical trials. This session will discuss cutting-edge techniques for leveraging proven ROI models and opportunities such as integrated applications, expert systems and translation research, global sites and new shared funding mechanisms.



Objectives:

Discuss how to improve the quality and effectiveness of collaborations between study stakeholders—including investigators, sponsors, funding agencies and institutional review boards—and how to integrate patient and trial data more accurately and quickly to improve safety and support better day-to-day decisions during clinical trials.

Discuss how to streamline the critical path for bringing new drugs to market through translational research to get rid of redundant review processes and unnecessary trial procedures.

Discuss how to leverage the evolving new models for funding clinical trials through public-private partnerships globally.