Use of Cardiac Safety Data in Early Phase Trials to Supplement or Replace a Thorough QT Trial
Cardiac safety assessment, and particularly the evaluation of a drug’s effect on QTc, are required for all new chemical entities. This webinar will discuss strategies for collecting cardiac safety data in early phases in order to complement or help with the design of a definitive QT trial, as well as the circumstances in which early phase QT assessment may be able to replace a standard Thorough QT Trial.
Key learning points: The webinar will address:
- How early phase ECG data can help de-risk a compound
- How early phase ECG data may help with the planning of a TQT
- How early phase ECG data may replace a TQT under certain circumstances
Best practices for ECG collection in early phase trials
*Participants limited at our discretion.
Robert Kleiman M.D.
Chief Medical Officer & Vice President, Global Cardiology
Dr. Robert B Kleiman is a board certified cardiologist and cardiac electrophysiologist who has performed research in both basic cellular electrophysiology as well as clinical electrophysiology. Dr Kleiman completed his training at the University of Pennsylvania, and was a member of a busy cardiology practice for 12 years, before joining ERT full time in 2003. Dr. Kleiman is currently ERT’s Chief Medical Officer and Vice President, Global Cardiology. His responsibilities include, oversight of ERT’s cardiology services as well as consulting with external clients.
* = required.