1. Better therapeutic trials in ovarian cancer
- Author
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Michael J. Birrer, Jonathan A. Ledermann, Michael A. Bookman, Carol Aghajanian, Elise C. Kohn, Kenneth D. Swenerton, Amit M. Oza, David G. Huntsman, C. Blake Gilks, and Karen O. Kaplan
- Subjects
Oncology ,Research design ,Cancer Research ,medicine.medical_specialty ,Drug Industry ,Disease ,law.invention ,Randomized controlled trial ,law ,Intervention (counseling) ,Internal medicine ,Research Support as Topic ,Biomarkers, Tumor ,Medicine ,Humans ,Molecular Targeted Therapy ,Pharmaceutical industry ,Neoplasm Staging ,Randomized Controlled Trials as Topic ,BRCA2 Protein ,Ovarian Neoplasms ,Government ,business.industry ,BRCA1 Protein ,Patient Selection ,medicine.disease ,Adenocarcinoma, Mucinous ,National Cancer Institute (U.S.) ,United States ,Cystadenocarcinoma, Serous ,Clinical trial ,Gene Expression Regulation ,Research Design ,Family medicine ,Mutation ,Commentary ,Female ,Drug Screening Assays, Antitumor ,Neoplasm Grading ,business ,Ovarian cancer ,Carcinoma, Endometrioid ,Adenocarcinoma, Clear Cell - Abstract
The Ovarian Task Force of the Gynecologic Cancer Steering Committee convened a clinical trials planning meeting on October 28โ29, 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.
- Published
- 2014