Key Challenges and Considerations
This webinar will explore some of the key challenges related to enrolling women into clinical trials as well as ideas for mitigating potential issues in cardiology-related device trials. In partnership with Boston Scientific, we will discuss the importance of women in clinical trials, current guidance on women in trials, assessments of data by gender, and hear about some of the work Boston Scientific has done in this space.
Bringing devices to market is a large and complex opportunity, and sponsors can face significant challenges when designing and conducting clinical trials for stents, valves, pacemakers, ventricular assist devices, and novel technologies.
In this webinar, the featured speakers will explore best practices for women in medical device trials, considering the:
• Opportunities and challenges in the clinical investigation of medical devices
• Importance of women in clinical trials
• Current guidance on women in clinical trials
• Impact of the female anatomy in device trials
Renee Sullivan, MD, FACC,
Senior Medical Director, Cardiovascular, Metabolic, Endocrine, Renal
Dr. Renee Sullivan is board certified in Internal Medicine and Cardiovascular Disease and trained in Clinical Cardiac Electrophysiology. As the Senior Medical Director at Covance she is responsible for providing medical and scientific expertise, consultation and leadership for project teams and site investigators; designing and reviewing clinical trial protocols; maintaining professional relationships with key opinion leaders; and performing medical monitoring for clinical research trials. In addition, she serves as a Covance medical expert in cardiovascular, cardiac electrophysiology and device-based therapeutics. Dr. Sullivan completed a combined BA/MD program at the University of Missouri- Kansas City and completed her residency and chief residency in Internal Medicine and fellowships in Cardiovascular Disease and Clinical Cardiac Electrophysiology at the University of Iowa Hospitals and Clinics.
Brooke Allocco, MD, MBA,
Vice President of Clinical Communications and Education for the Rhythm Group, Boston Scientific
Brooke Allocco currently serves as the Vice President of Clinical Communications and Education for the Rhythm Group of Boston Scientific Corporation. Her areas of responsibility include physician education and training, investigator sponsored research, clinical data strategy, and publication planning. She is also leading the WIN-Her initiative focused on increasing enrollment of women in clinical trials. Prior to Boston Scientific, Dr. Allocco was a Manager at the Boston Consulting Group, where she advised Fortune 500 healthcare companies on key strategic issues. She received her AB from Harvard University and her MD and MBA from Duke University.