The ISC: Providing Interim Analysis Data for DMCs
Consistent with the latest FDA and EMA draft guidances on adaptive design, drug development sponsors are increasing their use of external independent Data Monitoring Committees (DMC’s) for their adaptive designed Late Phase clinical trials.
To carry out their mission, DMC’s require timely and accurate statistical analyses and summaries of accumulating clinical trial data. Independent Statistical Centers (ISC’s) provide these analyses to DMC’s.Our Project Teams
Cytel has highly knowledgeable clinical trial statisticians, statistical programmers, and database managers with extensive ISC performance experience. They design, program, assemble, and validate interim analysis packages, including tables, listings, and graphs summarizing trial results to date.Our Experience
We’ve served as ISC in a wide range of therapeutic areas, including oncology, cardio-vascular, CNS, gastro-intestinal, and Diabetes clinical research.Our Technology
The regulatory guidances on adaptive design stress maintenance and documentation of the trials with regard to securing unblinded information to the DMC and the ISC, and keeping a “firewall” between them and the Sponsor.
Cytel’s ACES system supports adaptive design implementation in a secure, audit-trailed environment. ACES facilitates sponsor-committee communications and interim data handling as prescribed by regulatory guidance and according to the study protocol and committee charter.
Learn more about the ACES system and how it’s being used to support independent committees.