Data Monitoring Committee (DMC) Membership
Consistent with the FDA and EMA draft guidances on adaptive design, drug development sponsors using adaptive design late phase clinical trials are increasing organizing external independent Data Monitoring Committees (DMC’s, similar in function to Data Safety Monitoring Boards or DSMB’s).
Our Project Teams
Cytel has clinical trial statisticians with extensive experience participating with and on DMCs. They are highly knowledgeable about relevant statistical methods associated with clinical trials involving DMCs. These methods include, but not limited to, group sequential and adaptive designs, multiplicity, missing data, decision sciences, etc. They've interacted with steering committees of clinical trials, sponsors, and regulatory agencies on numerous clinical trials.Our Experience
The regulatory guidances on adaptive design stress maintenance and documentation of the integrity of clinical trials with regard to securing unblinded information to the DMC and Independent Statistical Center, and keeping a “firewall” between them and the Sponsor. Enter ACES, a software package which enables us to execute adaptive trials in a secure, audit trailed environment.