In-House vs. Out-Source: Operational Models for Data-Monitoring Committees

• Activity Number: 547
• Type: Contributed
• Date/Time: Wednesday, August 7, 2013 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Denka Markova*+ and William Coar and Lynn Navale
• Companies: Axio Research Inc. and Axio Research and Amgen
• Keywords: Data Monitoring Committee ; Operational Model ; Independent Statistical Center ; DMC ; DSMB ; ISC

Abstract

Data Monitoring Committees (DMCs) are now standard for many types of clinical studies, and have roles of protecting patient safety and ensuring quality conduct of the study. This is done through interim assessment of data throughout the course of a study and involves the Sponsor organization, an Independent Statistical Center (ISC), and the DMC. There is a spectrum of ways in which the ISC and Sponsor may arrange responsibilities, and several commonly used cases will be discussed.

One commonly used model is where the ISC performs all programming of the reports that are provided to the DMC. In this setting, the Sponsor facilitates data transfers from all external vendors to the ISC. Another common model is where the Sponsor provides the complete set of programs and data to the ISC. A third (less commonly used) method is where the Sponsor identifies an unblinded team internally to coordinate with the DMC thereby eliminating the involvement of an ISC. Merits associated with each model will be discussed.