Evolution of Translational Omics:

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ClinicalTrials.gov ID NCT00636441 NCT00509366 NCT00545948Disease Breast cancer Lung cancer Lung cancerStart date April 2008 February 2007 October 2007Date listed inclinicaltrials.govPatient accrualIntendedActualMarch 2008 July 2007 October 200727056Sponsor DOD Eli Lilly/Duke/NCI Eli Lilly/DukePI Markom, MD (Duke) Vhlahovic, MD, MHS(Duke)Chemosensitivity predictorDoxorubicin anddocetaxel8047Cisplatin11724Ready, MD, PhD (Duke;Comp. Cancer Center)Pemetrexed andVinorelbineTermination date 11/4/2010 11/4/2010 2/3/2011Citations inclinicaltrials.govThree Trials at Duke UniversityPotti et al., 2006aBild et al., 2006; Potti etal., 2006aPotti et al., 2006a,b;Potti et al., 2007b
Duke: Retracted Publications• Key retracted papers by Nevins and Potti: first five paper in the series• 2006 Nature Medicine (Potti et al.)‣ Cited 306 times• 2006 New England Journal of Medicine (Potti et al.)‣ Cited 350 times• 2007 Lancet Oncology (Bonnefoi et al.)‣ Cited 95 times• 2007 Journal of Clinical Oncology (Dressman et al.; Hsu et al.)‣ Cited 111 times, 60 times• Duke leadership identified 40 papers with Potti as co-author• Two thirds will be partially or fully retracted• Others may still be valid; pending evaluation (as of 8/11)• Surveyed 162 co-investigators: none had raised any questions
Page 1 and 2: Evolution of Translational Omics:Le
Page 3 and 4: Disclosure Information:Name of Spea
Page 5 and 6: Origin of the Task for the IOM Comm
Page 7 and 8: IOM Committee Composition20 member
Page 9 and 10: Omics• Encompasses multiple molec
Page 11 and 12: Omics-Based Test DevelopmentFramewo
Page 13 and 14: How are Omics Tests Different?• N
Page 15 and 16: Discovery Phase• Candidate test i
Page 17 and 18: Test Validation Phase
Page 19 and 20: How are Omics Tests Different?• R
Page 21 and 22: Evaluation for Clinical Utility and
Page 23 and 24: Case Studies (see report appendix)
Page 25 and 26: Statistical and Bioinformatics Vali
Page 27: Disclosure Information:Name of Spea
Page 36 and 37: Importance of:Lessons from the Duke
Page 38 and 39: Recommendation 2: Test Validation
Page 40 and 41: Big PictureRecommendations to ensur
Page 42 and 43: Recommendation 4: Institutions4c: I
Page 44 and 45: Recommendation 6: FDA6a: FDA should
Page 46 and 47: AcknowledgementsStudy Funders:Natio
Page 48 and 49: To download or read the report onli
Page 50 and 51: HER 2 Early single marker test for
Page 52 and 53: MammaPrint 70 gene microarray expre
Page 54 and 55: OvaCheck Serum proteomics-based app
Page 56 and 57: Allomap Blood test; measures expres

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