Adam Walker: Transformation in clinical data sources

Sam and Ivanna speak Adam Walker about the transformation in clinical data from his experience with CROs, sites and sponsors. Adam takes us through how clinical data collection has evolved from paper forms, to being collected digitally and now fully integrated with patients’ existing devices. This shift increases the volume of data available, the quality of the data, but also puts additional pressure on the industry to make sense of the data in real time. Adam makes the point that technology companies have an advantage in identifying the value of the information collected - not only for treatment, but also to support preemptive lifestyle choices. His advice for anyone working in this field is to “not take the comfy chair” of how we used to do things. 

“The data has not changed, but how we collect it has changed” 

• Adam Walker 

Notes

• Guest Adam Walker: https://www.linkedin.com/in/adam-walker-2327951/ 
• 21st Century Cures Act: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act  
• The 100 Year Life by Lynda Gratton and Andrew J Scott: https://www.100yearlife.com/ 
• Declaration of Helsinki: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ 
• ICH: https://www.ich.org/
• GCP: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical-practice
• CPRD: https://www.cprd.com/
• CDISC: https://www.cdisc.org/ 
• Clinical Trials overview: https://www.clinicaltrials.gov/ 
• Huxley Morton Podcast: https://www.huxleymorton.com/podcast.php 

Technology mentioned

• CTMS
• ePro
• eDiary
• RWE/ RWD
• AI/ ML
• EHR
• EDC
• Wearables
• Smartphones 
• Zoom

Functions mentioned

• Statistical Programming 
• Data Management 
• Biometrics

Abbreviations & Definitions

AI: Artificial Intelligence
CDISC: Clinical Data International Standards Consortium
CTMS: Clinical Trial Management System
CPRD: Clinical Practice Research Datalink
EDC: Electronic Data Capture
eDiary: Electronic Diary
EHR: Electronic Health Records
ePRO: Electronic Patient Recorded Outcomes
FDA: Food and Drug Administration 
GCP: Good Clinical Practice
ICH: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
MHRA: Medicines and Healthcare Products Regulatory Agency
ML: Machine Learning
NHS: National Health Service
RWD: Real-world Data
RWE: Real-world Evidence