How to Interpret an Investigator's Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum.

Jens RengelshausenKerstin Breithaupt-GroeglerFrank DonathKatharina Erb-ZoharTim HardmanGerd MikusStephanie PlassmannGeorg WensingHildegard Sourgens

Published in: Therapeutic innovation & regulatory science (2021)

The overall consensus was that an optimised presentation of data will ensure the best possible understanding of a compound's characteristics and an optimal benefit-risk assessment which will safeguard the participants in clinical trials.

Keyphrases

risk assessment
clinical trial
human health
heavy metals
electronic health record
big data
clinical practice
randomized controlled trial
machine learning
climate change