Cytel Webinars
Secure Access to Interim Analysis Data and Automated DMC/DSMB Management with ACES®
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For a majority of pivotal studies and virtually every confirmatory adaptive trial, the FDA and EMA want verifiable assurance that unblinded data access is controlled to eliminate the possibility of bias. Their respective guidance also makes clear the need for precise audit trails documenting "who saw what and when". Meeting all requirements significantly increases trial costs.
Link to the FDA's DMC Guidance or the EMA's document.
Cytel's ACES® (Access Control Execution System) is the only available solution and also improves support of conventional (non-adaptive) studies by automating processes for presenting safety data to the DMC/DSMB.
What you will learn
- How do you build firewalls and protect interim data from inappropriate access? What will satisfy regulators?
- What should be considered when forming the information paths for DMC/DSMB communications?
- When is it best to schedule an interim analysis for either safety concerns or adaptive design modifications?
- What extent can you automate generation of supporting documentation - the required medicinal, statistical and operational reports?
Where is ACES being used now in trials? Click to the confirmatory VALOR trial, a Phase 3 Acute Myeloid Leukemia treatment study.
A Q&A session will follow the host presentations and discussion.
Your Presenters
Eric Silva
Manager, Enterprise & Hosted Solutions, Cytel Inc.
Eric oversees the development and deployment of Cytel's ACES® (Access Control Execution System). The only system of its kind, ACES safeguards integrity of trials with interim analyses and automates complex committee-sponsor interactions.
Steven Ketchum, Ph.D.
Sr. Vice President, Research & Development, Sunesis Pharmaceuticals
Steven is a Research and Development leader at Sunesis with marked experience in late-stage product development and clinical regulatory strategy, having led the successful filings of multiple NDAs and supplemental NDAs. Steve is a coauthor with Sunesis and Cytel colleagues of the 2011 ASCO-accepted AML treatment utilizing an adaptive sample size re-estimation trial design strategy. Steven was also instrumental in forming VALOR's DSMB with interim analysis is expected in 2012.
Can't attend but interested in slides and webinar replay?
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