Rescuing a Suspended Gene Therapy Program by Applying Advanced Data Visualizations to Enable Robust Safety Monitoring

When the FDA put a clinical hold on further development of an intravitreal gene therapy, it was a serious setback for the Sponsor, as well as hopeful patients. Emmes SAS programmers and biostatisticians developed a robust monitoring system creating the needed data visualizations to ensure patient safety in order to rescue the gene therapy study. 

In this case study, Emmes experts discuss challenges and solutions for success in gene therapy clinical development.

Key topics covered and lessons learned include:

  • How to manage a Patient Monitoring Program to avoid delayed and incomplete data collection
  • Utilizing Patient Data Visualization program for timely and comprehensive reporting and analysis
  • Detecting the root cause of patient safety and efficacy through data-driven decisions
  • Data management and statistical strategy throughout clinical trials