title: SGO guidance document for clinical trial designs in ovarian cancer: a changing paradigm.
abstract: OBJECTIVE
  To explore and facilitate the multifaceted process of drug development and regulatory approval in ovarian cancer.
  
  
  METHODS
  The Society of Gynecologic Oncology (SGO) recently sought and received input from multiple stakeholders including the National Cancer Institute's (NCI) Clinical Therapy Evaluation Program (CTEP), the Food and Drug Administration (FDA), pharmaceutical industry, and patient advocates. This whitepaper is the work product and opinion solely of the SGO.
  
  
  RESULTS
  This document summarizes the SGO's interpretation of these meetings and the current regulatory environment where there has been a paucity of recent approvals in the United States. It provides guidance in clinical trial design with the express purpose of encouraging novel drug development in ovarian cancer. Points of emphasis include: ovarian cancer heterogeneity (histologic subtypes and molecular genetic alterations), clinical trial design elements, surrogate as well as composite endpoints, and the four principles of clinical drug development (unmet medical need, discovery, safety, and efficacy).
  
  
  CONCLUSIONS
  There has been an evolution in the acceptance of surrogate endpoints depending upon the clinical setting in ovarian cancer. While overall survival (OS) remains the most objective clinical trial endpoint, there is now realization that demanding OS as the primary endpoint has many obstacles. Ovarian cancer is a heterogeneous disease that is now divided by histologic subtypes. Future registration strategies will need to address disease heterogeneity. The exploration of currently acceptable clinical trial endpoints and alternative regulatory strategies will hopefully stimulate interest in novel drug development for patients with ovarian cancer.
authors.affiliation: University of Cincinnati, Cincinnati, OH, USA.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Herzog
authors.affiliation: University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Ronald D
authors.initials: RD
authors.lastname: Alvarez
authors.affiliation: Duke Cancer Institute, Durham, NC, USA.
authors.forename: Angeles
authors.initials: A
authors.lastname: Secord
authors.affiliation: University of Washington, Seattle, WA, USA.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Goff
authors.affiliation: University of Oklahoma, Oklahoma City, OK, USA.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Mannel
authors.affiliation: University of Arizona Cancer Center, Phoenix, AZ, USA.
authors.forename: Bradley J
authors.initials: BJ
authors.lastname: Monk
authors.affiliation: The University of Texas, MD Anderson Cancer Center, Houston, TX, USA. Electronic address: rcoleman@mdanderson.org.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Coleman
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D005260:Female; D006801:Humans; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017410:Practice Guidelines as Topic; D012107:Research Design; D016896:Treatment Outcome
keywords: Clinical trial endpoints; Ovarian cancer; Overall survival; Patient reported outcomes; Progression free survival