Accelerating Adoption of Risk-Based Monitoring in Clinical Trials

posted on September 5th 2014 in News & Events with 0 Comments /


Risk-based monitoring (RBM) is the future direction for modernizing how clinical trials are conducted. This spring Medidata and TransCelerate BioPharma Inc. announced a partnership to analyze and assess the relative contribution of source data verification (SDV) to overall clinical data quality.

The study is extensive and will leverage operational data and business analytics solutions from Medidata. Data collected over the last five years and from more than 7,000 clinical trials conducted throughout the world and by more than 120 sponsor organizations will be included in the analysis. The results will be published in the Fall of 2014 and co-authored by TransCelerate and Medidiata.

This is by far the most robust analysis of SDV-based trials to date. I’m excited to have this information, which can serve as a baseline comparator for future trials.

A few key areas where sponsors can leverage this clinical trial data includes:

  • The ability to analyze data across trials for the following TransCelerate identified key risk indicators: safety, subject recruitment and discontinuation, and data quality
  • Comparing audit changes and trends to identify protocol design issues by phase, therapeutic area, etc.
  • Evaluating protocol deviations across sites and study phase–an example is the ability to look at Phase II oncology trials and identify the sites in a particular country or region where the maximum number of protocol deviations occur
  • Benchmarking adverse events by disease state, study phase, and geographic location
  • Identifying sites that need oversight and quickly providing retraining

Ultimately, utilizing this baseline data helps sponsors determine indicators that assess clinical study quality and identify sites that are not performing optimally allowing clinical trial monitors to focus their time with the sites most in need of oversight.

The benefits of RBM include enhanced patient safety, improved trial oversight, more informed decisioning making, increased efficiencies across clinical trial operations, decreased costs for conducting clinical trials, and enhanced data integrity and compliance. Embracing the RBM methodology requires technology to support it. Together these provide significant benefits and enhance the quality of the clinical data sponsors collect.

Join the conversation and share your experiences, key learnings, and thoughts on areas to watch for as sponsors implement RBM-based monitoring. Are you moving toward RBM-based clinical trial monitoring? 

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