Ann Collins
Vice President, Clinical Development Syneos Health
Ann has over 20 years of experience in oncology drug clinical development. Ann is a proven leader in oncology global clinical program development, having been a sponsor lead for high-level FDA and EMA clinical/regulatory interaction (IND, EOP2, pre-NDA and ODAC) in hematologic malignancies. Through her experience in biopharmaceutical clinical trials and strategic development Ann has therapeutic and clinical/regulatory expertise in oncology as well as excellent working relationships with global key opinion leaders and cooperative groups dedicated to research in those areas.
WEDNESDAY, OCTOBER 28
10:30 AM Opportunities & Challenges for Using Real-World Data in Oncology Trials
Real-world data (RWD) is increasingly being used to facilitate and enhance clinical research in oncology. Opportunities for using RWD in oncology trials include assessing protocol feasibility by overlaying trial eligibility criteria onto a RWD source, identifying patients from RWD sources for inclusion in external control arms, and using RWD to augment data collection in long-term follow-up studies following gene therapy trials. However, it is easy to underestimate the challenges that arise in implementation.
This session will discuss the opportunities and challenges for RWD in oncology trials. Attendees will:
- Hear an overview of use of RWD sources in oncology trials
- What are the challenges related to use of RWD in any given trial
- Gain insight into opportunities to expand use of this approach with FDA, EMA and regulatory bodies around the world
The session will end with a live open question and answer discussion.
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