OBJECTIVES: 1)Understand how to navigate the regulatory environment, manage patient safety profiles, and achieve optimal process effectiveness in designing a Direct to Patient study; 2)Gather information on leveraging integrated technologies to support these studies; and 3)Learn key challenges and solutions from early Direct to Patient study implementations METHODS: The presentation will outline how to best design Direct to Patient studies to collect the right patient outcome data that will drive the most useful analysis. The presentation will look at the use of patient reported data to drive enrollment at the IND stage. Various methods of collecting patient data directly will be reviewed. RESULTS: Many questions are arising as the industry embarks on Direct to Patient programs, including how to navigate the regulatory challenges and various controls and guidelines. Other issues include how to address the changing role of investigators in this study model.Optimal roadmaps for designing Direct to Patient studies will be discussed, including the implementation of a flexible clinical and medical infrastructure to monitor patient participation. Issues such as the shift from site management to patient management, the process for management from recruitment to retention, and the processes for adverse event follow-up will be discussed. The optimal use of technology, such as portals, Randomization and Trial Supply Management technologies and ePRO data collection tools as well as the use of EDC in Direct to Patient programs will be discussed along with the right application of web-based and new social media tools. CONCLUSIONS: The increased need to have more outcomes and effectiveness data along with mounting pressure on the biopharmaceutical industry to contain costs have forced companies to look at new ways to manage studies more effectively and efficiently. There is a trend toward designing studies that reach out to patients directly in new ways, while at the same time eliminating costs and intermediaries associated with traditional studies.