Willie Muehlhausen: Transformation in patient reported outcomes (eCOA, ePRO and DCT)

Sam and Ivanna speak to Willie Muehlhausen about how simplifying and automating patient reported outcomes is not so much complicated, as it is complex. Willie shares his perspectives on the evolution of ePRO and eCOA and how the newer trend of decentralised clinical trials is closely tied to mastering the collection of patient reported outcomes. Willie is working towards making it possible to translate a clinical protocol into configuration in 12 minutes instead of 12 weeks and hints at other possibilities yet to be explored . If Willie could change one thing in our industry it would be increasing the level of knowledge sharing and knowledge retention. 

“The purpose is to get good data while making it easy for patients”  

• Willie Muehlhausen  

Notes & Links

• Guest Willie Muehlhausen
• eCOA Consortium (formerly known as the ePRO consortium) 
• Safira Clinical Research Limited 
• Recall Bias 
• CDISC
• ODM XML 
• Guidance on Ecological Momentary Assessment
• Considering BYOD in Clinical Trials 
• eConsent

Books by Willie Muehlhausen

• Patient Reported Outcomes
• Electronic Patient-Reported Outcome Measures: An Implementation Handbook for Clinical Research

Technology mentioned

• ePro
• eDiary
• eCOA
• AI/ ML
• EHR
• EDC
• PDAs

Functions mentioned

• CROs 
• Clinical Sites 
• Sponsors
• Data Management
• Statistical Programming 

Abbreviations & Definitions

AI: Artificial Intelligence

API: Application Programming Interface 

BYOD: Bring Your Own Device 

BYOT: Bring Your Own Technology 

CDISC: Clinical Data International Standards Consortium

CRA: Clinical Research Associate 

DCT: Decentralized Clinical Trial

EDC: Electronic Data Capture

eDiary: Electronic Diary

EHR: Electronic Health Records

ePRO: Electronic Patient Recorded Outcomes

EMAs: Ecologic