Ovarian Cancer Endpoints Workshop
Sept. 3, 2015
FDA White Oak Campus, Silver Spring, Maryland
Co-sponsored by FDA/AACR/SGO/ASCO
The Food and Drug Administration (FDA), hosted the “Ovarian Cancer Endpoints Workshop” with presentations by the Society of Gynecologic Oncology (SGO), the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO), on Thursday Sept. 3, 2015, at the FDA, White Oak campus Great Room, from 8 a.m. to 5 p.m. This workshop provided a forum for discussion of ovarian cancer, from the current state of science to novel clinical trial designs, biomarkers, statistical issues in clinical trials and how to evaluate new classes of agents such as immunotherapies.
Objectives of the workshop
The objective of this public workshop on ovarian cancer was to provide a venue for an in-depth discussion of the current science in ovarian cancer and potential new development pathways for ovarian cancer agents with the following goals:
- To review the current state of science of ovarian cancer biology and implications for clinical trial design;
- To discuss and explore emerging measures of treatment effect, including circulating factors and both tissue and imaging biomarkers;
- To discuss endpoints reflective of the diversity of disease and patient populations and how this impacts available trial designs and context for these endpoints; and
- To explore novel treatment designs relative to discovery and regulatory approval.