To Ensure Innovation In Clinical Trials, The Rules Need To Change

The COVID-19 pandemic accelerated the adoption of decentralized clinical trials, telemedicine, and remote monitoring, enabling continued drug and vaccine development while minimizing COVID-19 exposure, and demonstrating that these innovative approaches can meet FDA standards for data integrity and patient protection. Click here for article.

• Regulatory Modernization: The FDA needs to update regulations to support community-based clinical trials, focusing on oversight of trial personnel's qualifications and training rather than direct supervision by investigators.

• Digital Health Tools: Clear FDA guidance on the use and validation of digital health tools (DHTs) in clinical trials is necessary to mitigate regulatory risks and streamline their integration.

• Consistent Sponsor Roles: The decentralized nature of community-based trials requires clarity on sponsor roles and responsibilities to ensure patient safety and data integrity.

• Diversity in Clinical Trials: Continued support and clear guidelines are essential for improving diversity in clinical trials, ensuring they reflect the populations affected by the studied conditions.