Recent Advances in Addressing Recruitment, Enrollment and Retention of Women In Cardiovascular Medical Device Clinical Trials
Date(s) - 06/27/17
8:30 am - 10:00 am
Sunnyvale City Council Chambers- 456 West Olive Ave., Sunnyvale,
Event Speaker Title:
Director of Clinical Affairs
Event Speaker Company:
Event Speaker Bio:
Tamara (Tami) Shipman is an RN and clinical researcher with extensive experience from both the Investigator and Sponsor side for over 25 years. She has participated in and managed numerous studies in cardiology and electrophysiology. Tami is the Director of Clinical at Vascular Dynamics and is currently active in the Clinical Trials Group and the Ad Hoc Women’s Group at AdvaMed, a trade organization for the medical device industry.
While there has been some progress, gender bias and under-representation of women in cardiovascular medical device trials continues to be a challenging issue. The reasons for this under-representation are multi-factorial and include physician screening of trial subjects, gender gaps in the diagnosis of women with cardiovascular disease, misconceptions on the incidence of cardiovascular disease in women and trial designs that fail to appropriately capture women. The medical device industry has recently partnered with the FDA , advocacy groups, and physicians to develop strategies to address this long-standing issue. An update on the progress to date and current thinking on this topic will be discussed.