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June 7, 2007 @ 10:00am – 12:00pm EDT
Best Practices in Cardiac Safety Data Collection Before and After the Thorough QT Trial

- Jeffrey S. Litwin, M.D., F.A.C.C., Executive Vice-President, Chief Medical Officer, eResearchTechnology, Inc Learn More

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Recent years have seen a dramatic increase in focus on cardiac safety in new drug development.  ICH E14 guidance was finalized in May 2005.  An important component of the guidance is the requirement of the Thorough QT Trial (TQT) in the development of new drug candidates.  The decision for approval in reference to cardiac risk of the effect of a new drug on the ECG (especially QTc duration and cardiac repolarization) depends on the total data available. Dr. Litwin will review the QT work that should be done in Phase I prior to a TQT and to prepare for the TQT.  The TQT is the most important piece of the total risk assessment, however, it must be viewed in the context of ECG data in the Phase II-III target population, where one looks carefully for the presence of unexpected outliers.

click to registerThe main goal of ECG assessments in Phases II and III is to identify clinically relevant effects of the study drug, and any dose effect on cardiac intervals and/or morphology.  These assessments are extremely important to development programs in order to identify the electrocardiographic effects of the study drug in patients in whom the drug is intended.  eResearchTechnology, Inc. (eRT) has provided ECG Core Laboratory functions in support of thousands of studies throughout the world in virtually every therapeutic group.  This significant experience provides the basis for understanding the necessary technical and logistical functions and currently accepted best practices which should be considered prior to designing multi-center Phase II and III trials.

Dr. Jeffrey Litwin will provide current insights into the differences between Phase I versus Phases II-III and Phase IV cardiac safety testing.  He will address common ECG collection practices at sites versus best practices and when one approach may be preferred over another.  Dr. Litwin will address the impact of the TQT on Phase III programs and provide additional discussion on ECG data considerations beyond QTc.  Dr. Litwin will address how implementation of best practices ensures data quality and consistency and reduces data evaluation time.

Pre-web Cast Questions

  1. What is the difference between cardiac safety assessments in Phase I versus Phase II-III and Phase IV?
  2. When and how many ECGs should be acquired and how should ECG measurements and interpretations be conducted?
  3. How should ECGs be acquired at clinical sites and what is the role of local interpretation of ECG data?
  4. How should ECG data be analyzed?.

    EVPs, VPs, Directors, Heads, Managers, Principal Scientists of:

    • Clinical R&D
    • Clinical Operations
    • Regulatory Affairs
    • Medical Affairs
    • Outsourcing Management

    eResearchTechnology (eRT) provides technology and services that enable life sciences industries to collect, interpret and distribute cardiac data accurately and efficiently. eRT is a leading provider of centralized electrocardiographic (ECG) services and supports the full-range of studies from single center to multi-center global trials across all therapeutic groups. eRT is an industry leader for Thorough QTc Trials (TQT), having completed significantly more than any other core lab.

    EXPeRT® 2, eRT’s market leading analysis platform, provides secure and validated scalable capacity and efficient workflow processing. eRT offers best-practices digital collection, transmission and processing plus paper ECG processing and digital or paper rescue projects. eRT’s SOP-driven, cross-functional Project Assurance methodology encompasses pre-study planning, set-up, monitoring and close-out activities to ensure effective study conduct and drive superior performance metrics. eRT provides data access in a secure web platform plus flexible reporting options including XML waveforms.

    eRT’s global experience includes thousands of studies and currently includes 24/7 customer care, logistics and site support to over 17,000 investigation sites. eRT’s cardiologists consult on medical and regulatory issues related to cardiac safety, including protocol design and medical report writing. eRT has formal partnerships across the clinical services spectrum and can facilitate assembly of best-in-class cross-functional solutions.



    Jeffrey S. Litwin, M.D., F.A.C.C., Executive Vice-President, Chief Medical Officer, eResearchTechnology, Inc

    Jeffrey Litwin, M.D. is a board certified Internist and Cardiologist. He is currently an Executive VP and Chief Medical Officer for eResearchTechnology which he joined in 2000. He provides consultation to the Biopharmaceutical Industry for the design and conduct of cardiac safety trials and to the Device Industry for the design of ECG and Holter technologies. Dr. Litwin left his cardiology practice in 1988 to serve as Director, Medical Affairs, Wyeth-Ayerst Laboratories. Dr. Litwin also served as Executive VP and CEO of Executive Health Group in addition to Deputy Medical Director of Nutri/System. He was also a consultant to Schlumberger Ltd., and the American and National League of Professional Baseball Clubs.

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