Approved by the Expert Working Group on 7Mar2023, this final guidance was recently released. After the TOC, it starts with a glossary whose first entry is artificial intelligence. With the recent explosion of AI systems and the discussions on their use, that is certainly fitting (recognizing that, yes, the glossary is alphabetical). It includes an Executive Summary which nicely captures the content, including a focus on the patients and their rights. This guideline is also important as more and more trials are being decentralized with increased use of apps and devices for remote and in-home data collection.
Executive
summary
Computerised
systems are being increasingly used in clinical research. The complexity of
such systems has evolved rapidly in the last few years from electronic
case report forms (eCRF), electronic patient reported outcomes (ePROs)
to various wearable devices used to continuously monitor trial participants
for clinically relevant parameters and ultimately to the use of artificial
intelligence (AI). Hence, there is a need to provide guidance to all
stakeholders involved in clinical trials reflective of these changes in data
types and trial types on the use of computerised systems and on the collection
of electronic data, as this is important to ensure the quality and
reliability of trial data, as well as the rights, dignity, safety and
wellbeing of the trial participants.
This would ultimately contribute to a robust decision-making process based on such clinical data. This guideline will describe some generally applicable principles and definition of key concepts. It also covers requirements and expectations for computerised systems, including validation, user management, security, and electronic data for the data life cycle. Requirements and expectations are also covered related to specific types of systems, processes, and data.
I'll be reading this in detail today, since the implications are extensive for anyone working in clinical drug development.
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