Incorporating Site-less Clinical Trials Into Drug Development: A Framework for Action

Area of Science:

• Clinical Research
• Health Information Technology
• Drug Development

Background:

• Traditional clinical trials face challenges with paper-based processes, increasing costs and labor intensity.
• Evolving telemedicine technologies outpace the adoption of new methods in clinical research.
• Existing tools for collecting real-world data in home settings require closer examination for trial applications.

Purpose of the Study:

• To examine alternatives to traditional clinical trial models using telemedicine and remote data collection.
• To discuss advancements in site-less clinical research organization (CRO) practices and remote trial management.
• To consider investigator, sponsor, and regulatory perspectives on remote clinical trial methodologies.

Main Methods:

• The site-less CRO model utilizes pharmacists and health professionals for remote participant counseling and protocol compliance.
• Phone and videoconferencing sessions facilitate direct management of clinical trial participants from their homes.
• An expert panel convened to discuss remote clinical trial practices, including specialists in diseases, health IT, CROs, and the pharmaceutical industry.

Main Results:

• Site-less trial management provides real-time data from diverse patient populations in real-world settings.
• This methodology aids in the proactive identification of safety and operational issues.
• Current site-less CRO practices serve as a bridge to alternative trial models like "large simple trials".

Conclusions:

• Site-less CROs demonstrate the effectiveness of remote technologies and in-home monitoring in overcoming conventional drug development limitations.
• This model optimizes time and cost, potentially leading to earlier adverse event detection.
• Standardized strategies and coordinated communication among stakeholders are crucial for integrating site-less CROs into future study designs.