Institute for International Research

This workshop focuses on outlining the criteria needed to accurately recruit patients for clinical trials. Acknowledging the increasing demand for specialized patient populations, the speakers discuss topics currently relevant to this topic, such as:

• Who should control recruitment?
• How to diversify subject populations
• How to avoid ‘serial subjects'
• The industry's perspective on testing subjects abroad
• Examining patient recruitment companies
• Industry collaboration-creating a subject/patient participant database
• Consent forms
• What types of patients have greater value in drug development process?

Workshop Leaders:
Bryan McIntyre, Senior Vice President, INCLINIX
Richard Anthony, CEO, CATALYST PHARMA GROUP

This workshop led by ASTRAZENECA examines the use of QT/QTc studies to outline the decision making process and expectation for cardiac safety. The speaker will take workshop participants through the following:

• ICH E14: Update and Key Issues
• Planning a Thorough QT Study: Practical Issues
• Late Stage Development: QT Issues and Labeling
• Study Management Challenges Workshop

Leader:
Philip T. Sager, MD, FACC, FAHA, Executive Director, MSD/Global QT Strategy Leader, CV Research, ASTRAZENECA LP

Workshop Speakers:
Charles M. Beasley, Jr., MD, FRCPP, Distinguished Lilly Scholar; Chief Scientific Officer, Global Product Safety, ELI LILLY & COMPANY

Christopher H. Cabell, MD MHS FACC, Director, Cardiac Safety,
DUKE CLINICAL RESEARCH INSTITUTE; Chief Executive Officer, CORESEARCH

Polina Voloshko, MD, Vice President, Cardiovascular Clinical Services,
GENTIAE CLINICAL RESEARCH