title: Better therapeutic trials in ovarian cancer.
abstract: The Ovarian Task Force of the Gynecologic Cancer Steering Committee convened a clinical trials planning meeting on October 28-29, 2011, with the goals to identify key tumor types, associated molecular pathways, and biomarkers for targeted drug intervention; review strategies to improve early-phase screening, therapeutic evaluation, and comparison of new agents; and optimize design of randomized trials in response to an evolving landscape of scientific, regulatory, and funding priorities. The meeting was attended by international clinical and translational investigators, pharmaceutical industry representatives, government regulators, and patient advocates. Panel discussions focused on disease types, early-phase trials, and randomized trials. A manuscript team summarized the discussions and assisted with formulating key recommendations. A more integrated and efficient approach for screening new agents using smaller selective randomized trials in specific disease-type settings was endorsed, together with collaborative funding models between industry and the evolving national clinical trials network, as well as efforts to enhance public awareness and study enrollment through advocacy.
authors.affiliation: Affiliations of authors: University of Arizona Cancer Center, Tucson, AZ (MAB); Department of Pathology and Laboratory Medicine, Vancouver General Hospital, Vancouver, BC, Canada (CBG); Molecular Signalling Section, Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD (ECK); Director, Policy and Advocacy, Prevent Cancer Foundation, Alexandria, VA (KOK); Pathology and Laboratory Medicine (DH) and Department of Medical Oncology (KDS), University of British Columbia, Vancouver, BC, Canada (DH); Department of Medical Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY (CA); Department of Medicine, Harvard Medical School, Massachusetts General Hospital, Boston, MA (MJB); CR UK/UCL Cancer Trials Centre, University College London Cancer Institute, London, UK (JAL); Division of Medical Oncology and Hematology, Princess Margaret Hospital, Toronto, ON, Canada (AMO).
authors.forename: Michael A
authors.initials: MA
authors.lastname: Bookman
authors.forename: C Blake
authors.initials: CB
authors.lastname: Gilks
authors.forename: Elise C
authors.initials: EC
authors.lastname: Kohn
authors.forename: Karen O
authors.initials: KO
authors.lastname: Kaplan
authors.forename: David
authors.initials: D
authors.lastname: Huntsman
authors.forename: Carol
authors.initials: C
authors.lastname: Aghajanian
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Birrer
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: Ledermann
authors.forename: Amit M
authors.initials: AM
authors.lastname: Oza
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Swenerton
mesh_terms: D018262:Adenocarcinoma, Clear Cell / Q000188:drug therapy; D002288:Adenocarcinoma, Mucinous / Q000188:drug therapy; D019313:BRCA1 Protein / Q000378:metabolism; D024682:BRCA2 Protein / Q000378:metabolism; D014408:Biomarkers, Tumor / Q000097:blood*; D018269:Carcinoma, Endometrioid / Q000188:drug therapy; D018284:Cystadenocarcinoma, Serous / Q000188:drug therapy; D004345:Drug Industry; D004354:Drug Screening Assays, Antitumor / Q000379:methods / Q000592:standards / Q000639:trends; D005260:Female; D005786:Gene Expression Regulation; D006801:Humans; D058990:Molecular Targeted Therapy; D009154:Mutation; D054547:National Cancer Institute (U.S.); D060787:Neoplasm Grading; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism / Q000473:pathology; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards / Q000639:trends; D012107:Research Design; D012109:Research Support as Topic; D014481:United States
chemical_list: D019313:BRCA1 Protein; C492913:BRCA1 protein, human; D024682:BRCA2 Protein; C551750:BRCA2 protein, human; D014408:Biomarkers, Tumor