The Utilization of Externally Sourced Data and Data Collected and Analyzed from Previously Completed Studies Using...

Area of Science:

• Clinical research
• Regulatory affairs
• Data science

Background:

• Clinical trials face numerous challenges, including rare diseases, limited sites, complex procedures, and parental consent issues in pediatric studies.
• These difficulties can impede the successful and timely achievement of regulatory commitments.
• Strategies to supplement trial data are crucial for meeting regulatory requirements.

Purpose of the Study:

• To review clinical trials and regulatory commitments that successfully incorporated external data.
• To assess the use of data from previously completed internal studies in regulatory submissions.
• To highlight the potential of these strategies in overcoming common clinical trial barriers.

Main Methods:

• Conducted a review of clinical trials and regulatory commitments.
• Identified instances where externally sourced data was utilized.
• Analyzed the inclusion of data from previously completed internal studies.

Main Results:

• Externally sourced data and data from completed internal studies can supplement clinical trial data.
• This approach can add robustness to regulatory submissions.
• The strategy is effective in addressing gaps caused by recruitment barriers and other challenges.

Conclusions:

• The utilization of external data and prior internal study data is a valuable strategy.
• This method can significantly enhance regulatory submissions, especially when facing recruitment difficulties.
• Increased awareness and adoption of these data supplementation techniques are recommended.