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Clinical Trials Clinician’s Perspective Wael Harb, MD Director of Oncology & Director of Research IU Health Arnett This session will: • • • Explain the clinical trial process Illustrate the importance of participation in clinical trials Identify ways that you can get involved Ovarian Cancer • 2012 Estimates for ovarian cancer in the United States: –About 22,280 women will receive a new diagnosis of ovarian cancer. –About 15,500 women will die from ovarian cancer. 3 Background on Clinical Trials • Clinical trials are only a small part of the research that goes into developing a new treatment • • • • • • • Drugs of the future first have to be: Discovered by scientists Purified by researchers Described as a compound Tested on animals Tested in labs for many years before reaching human clinical trials Background on Clinical Trials • A new cancer drug will undergo years of discovery research before reaching a clinical trial Background on Clinical Trials Research… it Matters The “OMICS” Revolution Genomics Proteomics BLOOD Finding a needle in a haystack Lipidomics Metabolomics Control No Disease Cancer Cancer Research… it Integrated “omics” analysis Matters Genomics Proteomics BLOOD Molecular Signature Lipidomics of cancer Metabolomics No Disease Cancer Figure 5"> Tothill, R. W. et al. Clin Cancer Res 2008;14:5198-5208 Copyright ©2008 American Association for Cancer Research Research is the only way to find cures • Medical breakthroughs are the results of clinical trials • Based on what researchers have learned in the past about cancer, new treatments can be developed in a more logical way New Drugs in the Pipeline • Innovations in drug development • New discoveries in molecular and cell biology • New compounds that are in preclinical and early phase trials Clinical Trial Participation • Increased patient participation in clinical trials • will help further research Benefits of Patient Advocates • Patient Advocates can help increase • participation in clinical trials by raising • awareness within – The Community – Treatment Centers – Local Hospitals – Local Organizations How Can Research Advocates Help Research? • Research advocates support conducting ethical, well-designed research and work to disseminate the results of that research so that new and better treatments are available in communities throughout the United States. How Can Survivors Help the Research Process? • Help reduce the barriers patients face in gaining access to clinical trials • Provide resources to patients and their families • Provide a link to the community • Increase awareness about clinical trials • Develop/review patient education materials • Match prospective clinical trial participants with a survivor that was a participant What Skills do Survivors Need? • Desire to make things better • Communication skills • Ability to represent all patients and not just your personal “story” • Willingness to learn the basics of science/treatments • Be able to work collaboratively