NCI case report form standardization activities in the Cancer Biomedical Informatics Grid

1. NCI Clinical Case Report Form (CRF) Standardization Activities George A. Komatsoulis, Ph.D. Deputy Director Center for Biomedical Informatics and Information Technology (CBIIT) National Cancer Institute

2. “ A wonderful fact to reflect upon, that every human creature is constituted to be that profound secret and mystery to every other.” Charles Dickens: A Tale of Two Cities 1859

3. Childhood Cancer: Dramatic Improvement in Survival *5-year relative survival rates, based on follow up of patients through 2003. Source: Surveillance, Epidemiology, and End Results Program, 1975-2003, Division of Cancer Control and Population Sciences, National Cancer Institute, 2006. 5 - Year Relative Survival Rates * Age Year of Diagnosis 0 - 4 Years 5 - 9 Years 10 - 14 Years 1975 - 1977 1996 - 2002 1975 - 1977 1996 - 2002 1975 - 1977 1996 - 2002 79.7 77.9 80.1 58.8 58.2 57.3

4. High Participation in Clinical Research Winchester et al., CA Cancer J Clin 2001;51;119-130

5. Childhood ALL: Molecular Sub-types Impact Risk Tsao et al. Modern Pathology (2004) 17: 832–839 Rubnitz and Pui, Oncologist ( 1997) 2 :374-380

8. “ And the Lord said, Behold, the people is one, and they have all one language; and this they begin to do; and now nothing will be restrained from them, which they have imagined to do. Go to, let us go down, and there confound their language, that they may not understand one another's speech.” Genesis , Chapter 11, 500-450 BCE “ What we have here is… failure to communicate” Strother Martin in Cool Hand Luke 1967

9. Attribute Value Agent NSCNumber 007 Name Taxol

10. Attribute Value NCI Meaning Agent A chemical compound administered to a human being to treat an existing disease or condition, or prevent the onset of a disease or condition nSCNumber 007 Identifier given to a chemical compound by the US Food and Drug Administration (FDA) Nomenclature Standards Committee (NSC) Name Taxol Name of a chemical compound given by the NCI Cancer Therapeutics Evaluation Program (CTEP)

11. Attribute Value NCI Meaning CIA Meaning Agent A chemical compound administered to a human being to treat an existing disease or condition, or prevent the onset of a disease or condition A sworn intelligence agent; a spy nSCNumber 007 Identifier given to a chemical compound by the US Food and Drug Administration (FDA) Nomenclature Standards Committee (NSC) Identifier given to an intelligence agent by the National Security Council Name Taxol Name of a chemical compound given by the NCI Cancer Therapeutics Evaluation Program (CTEP) Code name given to intelligence agents by the Central Intelligence Agency (CIA)

12. Attribute Value NCI Metadata CIA Metadata Agent A chemical compound administered to a human being to treat an existing disease or condition, or prevent the onset of a disease or condition A sworn intelligence agent; a spy nSCNumber 007 Identifier given to a chemical compound by the US Food and Drug Administration (FDA) Nomenclature Standards Committee (NSC) Identifier given to an intelligence agent by the National Security Council Name Taxol Name of a chemical compound given by the NCI Cancer Therapeutics Evaluation Program (CTEP) Code name given to intelligence agents by the Central Intelligence Agency (CIA)

14. The ISO 11179 Model in the caDSR

15. The cancer Data Standards Repository (caDSR)

16. Enterprise Vocabulary Service (EVS)

17. Square Pegs and Round Holes

19. Clinical Trials Working Group (CTWG) CTWG Goal CTWG Initiative Enhanced Coordination Establish a comprehensive database containing regularly-updated information on all NCI-funded clinical trials Enterprise Wide Standardization Achieve industry and FDA concurrence on standard Case Report Forms incorporating Common Data Elements Promote establishment of national clinical trial information technology infrastructures that are fully interoperable with NCI’s cancer Biomedical Informatics Grid (caBIG™) Develop a credentialing system for investigators and sites that is recognized and accepted by NCI, industry sponsors, clinical investigators, and clinical trial sites

21. “ Genius is one percent inspiration and ninety-nine percent perspiration” Thomas Alva Edison, Harper’s Monthly , September 1932

22. Case Report Forms Based on Common Data Elements (CDEs)

33. ἄνδρα μοι ἔννεπε, μοῦσα, πολύτροπον, ὃς μάλα πολλὰ πλάγχθη, ἐπεὶ Τροίης ἱερὸν πτολίεθρον ἔπερσεν Ὅμηρος : Οδύσσεια “ Tell me, O Muse, of the man of many devices, who wandered full many ways after he had sacked the sacred citadel of Troy” Homer: The Odyssey (8 th Century BCE)

38. CRF Planning Matrix