Title of Abstract Presentation:
A Global Rheumatoid Arthritis Trial Involving Biologic vs. Biosimilar: The Medical Affairs and Clinical Operations Challenges

Dr. Nermina Nakas, MD, MPH
Executive Medical Director, 
Medical Management and Scientific Services
Syneos Health 

Dr. Maria Marta Harrington, MD
Medical Director 
Medical Management and Scientific Services
Syneos Health 


Abstract Interest Area/Track: 
Clinical Operations

Key Words:
Biosimilar, Clinical Operations, CRO, Global Trials, Medical Affairs, Rheumatoid Arthritis

Objective:
Describe and discuss Medical Monitor (MM) team spirit, clinical trial related considerations, encountered challenges, notable successes and lessons learned in MM day-to-day activities with sites and project teams.

Method:
A Phase III, multinational rheumatoid arthritis trial, enrolled over 650 patients, conducted in over 115 sites in 13 countries, in North America, South America and Europe, with Contract Research Organization performing selected services including Clinical Operations and Medical Monitor full service.

Results:
Medical Monitors input to the site selection and feasibility, and Principal Investigator (PI)/Key Opinion Leader (KOL) follow up was crucial by supporting the PI/KOL active collaboration.  Rheumatoid Arthritis Biosimilars is a competitive area needing a Global feasibility to identify sites (over 400 sites were contacted).   

The MMs led on-going site/PI/KOL WebEx conference trainings with Question and Answer (Q & A) sessions and peer-to-peer lessons learned were discussed in detail. Additionally, Medical Monitors conducted 1:1 calls with PIs/KOLs as needed.  The project team communication, internal and external, was notably remarkable. The quarterly Newsletters to the sites and Investigators were implemented to boost a healthy PI competition, and included MMs reviews of rheumatoid arthritis articles of interest.

The screen failure rate was on the high end due to some specific protocol requirement for entry criteria(s).  The Medical Monitors involvement with the Clinical Operations team has tremendously supported the recruitment and enrollment to achieve First Patient In (FPI) on schedule and to reach on time the 100% randomization target in 11 countries that were enrolling subjects.  Monthly Safety MM meetings were ongoing for medical and safety data listings review.  The Serious Adverse Event (SAE) rate and TB conversion reported was as expected for other biosimilars.  Latent TB prophylaxis treatment was in place as per the sites standard of care with close contacts and follow ups by Medical Monitors.  

Conclusion:
In this presentation, we will share our challenges in medical monitoring a global rheumatoid arthritis trial.  Effective relationships between Medical Monitors, Clinical Operations team and the sites are noted as one of the key factors for success. The Medical Monitor lessons learned we would present as a peer-to-peer educational effort.

A Global Rheumatoid Arthritis Trial Involving Biologic vs. Biosimilar: The Medical Affairs and Clinical Operations Challenges

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