Details of person submitting   
Name Jagat Mishra
Organisation Parexel
Email jagat.mishra12@gmail.com
   
Details of abstract   
Title of abstract  Smart data collection for smart trials by BYOD
Abstract 

Internet-based devices has offered paradigm shift in how data is being captured for clinical trials, patient-reported outcome (PRO) assessments, including measures of signs, symptoms, and events that are administered outside of the site are critical in safety & efficacy evaluation of novel drugs, data collection here commonly involves providing subjects with stand-alone electronic devices as smartphones, that they can use to respond to assessments in their home or work environment. Although this approach is useful but has limitations as well-as provisioning stand-alone devices can be costly for sponsors and requiring subjects to carry a device that is exclusively dedicated to the study can be burdensome. The “Bring Your Own Device” (BYOD) approach, in which subjects use their own smartphone or Internet-enabled devices to complete field-based PRO assessments, addresses many of these concerns, BYOD model has enabled cost-effective deployment of electronic patient communication and data capture, BYOD has ability to gather data on a real-time basis, instead of when the subject is holding the provisioned device. Real world evidence, a current focus of the Federal Drug Administration, is also easy to gather in the BYOD environment and lets researchers focus on subjects’ activity levels, location, environmental exposures, nutrition, and social-behavior patterns. In future as, smart & zero site trials are on their way we can see BYOD would be an integral part of data management.

 

First learning objective Smart Data collection & Management
Second learning objective Project Management
Third learning objective
   
Presenter Details  
Name  Jagat Mishra 
Organisation Parexel
Job title Clinical Data Analyst