Remote Monitoring in Clinical Trials During the COVID-19 Pandemic

Area of Science:

• Pharmaceutical Science
• Clinical Trial Management
• Digital Health

Background:

• The COVID-19 pandemic accelerated the need for remote clinical trials.
• The pharmaceutical industry has limited experience with remote measurements.
• Key questions exist regarding candidate selection, data validity, and regulatory aspects of remote assessments.

Purpose of the Study:

• To propose a decision-making framework for transitioning clinical assessments to remote settings.
• To identify critical activities for ensuring the validity, safety, and usability of remote measurements.
• To address the challenges faced by the pharmaceutical industry in implementing remote clinical trials.

Main Methods:

• Development of a decision tree for migrating clinic-based assessments to remote modes.
• Identification of key considerations for remote data collection.
• Review of regulatory implications for remote trial components.

Main Results:

• A structured decision tree is presented to guide the migration process.
• Essential activities for validating remote measurements are highlighted.
• The framework addresses candidate selection, data integrity, and regulatory compliance.

Conclusions:

• The proposed decision tree facilitates the strategic implementation of remote clinical trials.
• Ensuring the validity, safety, and usability of remote assessments is crucial for successful trial execution.
• This approach helps the pharmaceutical industry navigate the complexities of remote clinical trial operations.