Risk Based Monitoring (RBM): A global study focusing on perception and merits among clinical investigational sites

Area of Science:

• Clinical research methodology
• Drug development operations
• Regulatory science

Background:

• Risk-Based Monitoring (RBM) aims to enhance subject safety, data integrity, and cost-efficiency in clinical trials.
• Limited global data exists on clinical staff perceptions and confidence in RBM.
• This study investigates RBM applicability and adaptability among global clinical research staff.

Purpose of the Study:

• To assess global clinical research staff perceptions of Risk-Based Monitoring (RBM).
• To evaluate RBM's impact on clinical trial cost, data quality, and subject safety.
• To determine the readiness for RBM adoption across developed and emerging countries.

Main Methods:

• A validated 12-item electronic questionnaire was distributed globally to 3000 clinical research staff.
• Survey responses were analyzed based on participant demographics and clinical research experience.
• Data collected included perceptions of RBM's effect on cost, data quality, subject safety, and adoption readiness.

Main Results:

• Responses were received from 595 participants across 10 countries (6 emerging, 4 developed).
• No significant difference in perceived cost reduction was found between emerging and developed countries (p=0.20).
• Researchers from emerging countries showed higher confidence in RBM for data quality (p=0.006), patient safety (p=0.05), and fraud detection (p=0.01), and greater readiness for adoption (p<0.0001).

Conclusions:

• The study highlights a strong need for global RBM training and regulatory guidance.
• Implementing RBM systematically can improve subject safety and clinical trial data quality.
• Further research with larger sample sizes is recommended for an evidence-based approach to RBM implementation.