Human Factors Session Spotlight: Linking HF to Clinical Trials – Can Clinical Trials Be a Source of Human Factors Information, or Not?

Clinical studies on the drug component of many drug-device combination products are conducted simultaneously, yet independently of the human factors studies. If there is a delay on one of these studies, the market launch of the combination product can be delayed.  This May in Bethesda, Maryland, experts from P/L Biomedical, MannKind Corporation and Hospira gather to discuss the  interface between the clinical drug study and the human factors device study to see where there are opportunities for greater synergy and efficiency.

The Human Factors for Drug-Device Combination Products Summit will take place May 14-15, 2013.  For more information on this session and the rest of the agenda, download the brochure.  If you'd like to join us in Maryland, as a reader of this blog when you register to join us and mention code HFJP13, you'l save 20% off the standard rate!

Featured Session: Linking HF to Clinical Trials – Can Clinical Trials Be a Source of Human Factors Information, or Not?

Participants:
Moderator: Lee H. Leichter, RAC, MBA, President, P/L Biomedical
Panelists: Chad Smutney, Senior Director, Device Technology, MannKind Corporation
Seema Kumbhat, MD., Medical Director, Drug Device Development, Hospira

About the session:
• How are clinical studies affected? Should they be conducted at the same time as when you’re conducting HF usability studies?
• What data can/cannot be collected effectively in a clinical trial?
• Can you link clinical trials to human factors studies to come up with elements during trials to show that you’ve probed patient user usage and that residual error is acceptable?
• Medical / clinical perspective on leading human factors programs at corporations: strengths/pitfalls

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