Objective: Understand clinical trial use cases where the OHDSI platform & ecosystem can aid trials in any aspect, and assist in driving updates in OHDSI tools to support. This might be to represent data from interventional trial or observational study in OMOP CDM, might include enabling feasibility analysis, might include trial data collection, supporting biostatistics, or delivering real-world evidence to help trialists, or other.

Project Lead: Sonia Araujo, IQVIA London (sonia.araujo@iqvia.com)

Members:

• Andrew Williams, PhD, Tufts
• Greg Klebanov, MS, Odysseus
• Rupa Makadia, PhD, Janssen
• Vojtech Huser, PhD, NIH
• Chris Roeder, MS, Colorado
• Thomas Falconer, MS, Columbia
• Josh Ransom, PhD, Medidata
• Ryan Li, Columbia
• Ana Heredia, GMV
• Ayesha Kang, Deloitte
• Kees van Bochove, MS, The Hyve
• Maxim Moinat, MS, The Hyve
• Sonia Araujo, PhD, IQVIA
• Jill Hardin, PhD, Janssen
• Shawn Dolley, MBA consultant to Gates Foundation

Start Date: 2019 (this started as 'Clinical Study' working group in 2016 and was dormant)

Repository:

• https://github.com/vojtechhuser/project/tree/master/sdtm-omop
• White Paper: Using RWE in Trials by SHYFT Analytics
• Poster: Leveraging the OMOP CDMv5 for CDISC SDTM RCT Data
• Webinar: 7 Ways to Compress Your Clinical Trial (registration required)
• All Identified Use Cases Joining Clinical Trial Data with Real World Data
• The Hyve presentation on clinical trials in OMOP 20190412