Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology white paper.

ABSTRACT:

Objective

To explore the value of multiple clinical endpoints in the unique setting of ovarian cancer.

Methods

A clinical trial workgroup was established by the Society of Gynecologic Oncology to develop a consensus statement via multiple conference calls, meetings and white paper drafts.

Results

Clinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics. Selection of the optimal clinical trial endpoint is particularly provocative in ovarian cancer where long overall survival (OS) is observed. The lack of new regulatory approvals and the lack of harmony between regulatory bodies globally for ovarian cancer therapeutics are of concern. The advantages and disadvanta

SUBMITTER: Herzog TJ 

PROVIDER: S-EPMC4702266 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature