Scribe

Executive Summary

Patient-reported outcome data is of increasing importance to clinical research, but its collection and integration into the research data set is still stuck in the dark ages. In 2016, we have access to terrific online ways to capture the data, ways which allow us to also eliminate major pain points in use of patient-reported data. From modern methods of data collection to proper real-time validation to efficient transmission into existing data systems, Scribe aims to ease these pain points.

Clinical research teams have traditionally asked patients to fill out numerous paper surveys which ask about symptoms, function, and other markers. These forms then have to undergo manual checks for validity and quality, after which they are entered by hand into data systems. Frequently, the systems capturing this data aren’t the ones being used by investigators to capture the primary clinical- and laboratory-based data for their studies, leading to further difficulty at the time of analysis.

To address this, we are building a flexible, simple-to-use web-based system which can provide patients with a way to answer the surveys online. The data will undergo real-time validation and quality assurance, and will feed directly into each study’s primary data repository — allowing ongoing, near-real-time analysis as well as notification of clinical issues which might need further followup by the study team.

A project supported by the: HHS Ignite Accelerator

Team Members

Jason Levine (Project Lead), National Cancer Institute, NIH
Rohit Paul, National Cancer Institute, NIH

Milestones

March 2016: Project selected into the HHS Ignite Accelerator
April 2016: Time in the Accelerator began

Project Sponsor

Tom Misteli, Director, Center for Cancer Research, NCI, NIH