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FDA ovarian cancer clinical trial endpoints workshop: A Society of Gynecologic Oncology White Paper
Journal article   Open access  Peer reviewed

FDA ovarian cancer clinical trial endpoints workshop: A Society of Gynecologic Oncology White Paper

Thomas J. Herzog, Gwynn Ison, Ronald D. Alvarez, Sanjeeve Balasubramaniam, Deborah K. Armstrong, Julia A. Beaver, Annie Ellis, Shenghui Tang, Peg Ford, Amy McKee, …
Gynecologic oncology, Vol.147(1), pp.3-10
10/2017
PMID: 28844539

Abstract

Clinical trial endpoints Immunotherapy Ovarian cancer Patient reported outcomes Rare tumors Regulatory approval
•Epithelial ovarian cancer is a constellation of diseases challenging development.•Patient classification systems should incorporate multiple descriptive factors.•New platforms for drug development (e.g. neoadjuvant chemotherapy) are encouraged.•Patient advocate collaborators are vital to meeting the many challenges of enrollment.•Surrogate endpoints (e.g. PFS and response) are viable for accelerated approval.
url
https://doi.org/10.1016/j.ygyno.2017.08.012View
Published (Version of record) Open

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