Recomendaciones y Normativas aplicadas a tareas de Gestión de Datos y Estadística

1. Recomendaciones y Normativasaplicadas a tareas deGestión de Datosy Estadística Ferran Torres Ferran.Torres@uab.es Dirección Departamento de Bioestadística y Gestión de Datos de CAIBER Statistics and Methodology Support Unit (USEM). Hospital Clinic Barcelona Biostatistics Unit. School of Medicine. Universitat Autònoma de Barcelona (UAB)

2. Today’s lecture is on Statistics

5. Documentación http://ferran.torres.name/edu/caiber • Presentación pps // pdf • Algunas referencias y material adicional • Recomendaciones y normativas científicas • Consort:  resumida, // general, // no-inferioridad • Moose: Meta-análisis estudios Observacionales • Quorum => PRISMA: Meta-análisis Ensayos Clínicos • Strobe: Observacionales • Stard: Pruebas Diagnósticas • Medicina clínica: Monográfico Med Clin. Comprobación tipos de estudios. • - Ensayos Clínicos (CONSORT) // Recomendaciones reguladoras

6. http://www.equator-network.org/resource-centre/library-of-health-research-reporting/http://www.equator-network.org/resource-centre/library-of-health-research-reporting/

8. SERVICIOS PERIFÉRICOS DE INSPECCIÓN FARMACÉUTICA SISTEMA ESPAÑOL DE FARMACOVIGILANCIA

9. Globalización

10. AGENCIAS REGULADORAS

11. EMA committees SAWP CHMP (Committee for Medicinal Products for Human Use) Chair : Dr. E. Abadie – Vice Chair: Dr. T. Salmonson COMP (Committee for Orphan Medicinal Products) Chair : Dr. K. Westermark – Vice Chair: Mrs. B. Byskov Holm HMPC (Committee for Herbal Medicinal Products) Chair: Dr. K. Keller - Vice-Chair: Dr. I. Chinou PDCO (Paediatric Committee) Chair: Dr. D. Brasseur - Vice-Chair: Dr Dirk Mentzer CAT (Committee for Advanced Therapy Medicinal Products) Chair: Dr. C. Schneider - Vice-Chair: Prof. P. Salmikangas

12. Working Party Constellation Pharmacogenomics Biosimilars Urology Biostatistics SAG CVS SAG diagnostics Radiopharmaceuticals Blood Prod Respiratory SAG Neurology QWP* Patients & Consumers Gastroenterology CHMP Cardiovascular SWP* Vaccines CNS PhVig* SAG Psychiatry Cardiovascular Rheumatology Immunology BWP* Sci Adv SAG Diabetes Vaccines Infectious Diseases * 1 / MSrepresentation Pharmacokinetics SAG HIV / Antiviral Oncology SAG Anti-Infectives SAG Oncology

13. Biostatistical/Methodological guidanceshttp://ferran.torres.name/download/material_comun/guias.htm

15. Listas de comprobación 16

16. Other regions Canada Sweden SweCRIN Denmark DCRIN Ireland ICRIN EFGCP UK UK-CRN EORTC and other EU countries Aus, Bel, NL… Germany KKS France CIC & UEC Hungary HECRIN Spain SCReN CAIBER Italy IRFMN & CIRM National networks of Clinical Research Centres / Clinical Trial Units www.ecrin.org

17. ECRIN, an integrated infrastructure for clinical trials in the EU • ECRIN-1 (2004-2005) : • Identifying bottlenecks • ECRIN-2 (2006-2008) : • Preparing the infrastructure • ECRIN-3 (2008 -> ) : FP7 ESFRI roadmap • Running the infrastructure supporting multinational clinical trials in the EU • In line with expectations of FP7 ‘Innovative Medicines Initiative’ www.ecrin.org

18. ECRIN-1 (2004-2005) : identifying bottlenecks ECRIN-RKP (FP6-funded): -> survey and comparative analysis on 1 - Structures and objectives of centres and networks 2 - Financing, sponsoring 3 - Ethics 4 - Legislation, regulatory affairs, insurance 5 – Adverse event reporting, drug dispensing 6 – Methodology, data management, data monitoring 7 - Quality management, SOPs, audits 8 - Communication, partnerships 9 - Study registers 10 – Education and careers -> reports on www.ecrin.org www.ecrin.org

19. ECRIN-2 (2006-2008) :preparing the infrastructure ECRIN TWG (FP6-funded) TRANSNATIONAL WORKING GROUPS : -> Guidelines and procedures 1 - ethics 2 - regulation 3 - adverse event reporting 4 - data management 5 - monitoring 6 - quality assurance – SOPs 7 - education www.ecrin.org

20. ECRIN-3 (2008-) : Integrated services to multinational studies (1) • Flexible, integrated services (one-stop shop) in the conduct of the study 1 - interaction with ethics commitees 2 - interaction with competent authorities, regulatory affairs 3 - drug dispensing 4 - adverse event reporting 5 - data management 6 - data monitoring 7 - management of biological samples www.ecrin.org

27. Documentos a tener en cuenta • Regulatory Documents • Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) • European Directive for the implementation of GCP 2001/20/EC • Directive 95/46/EC of the European Parliament and of the council of 24 October 1995 • Guidance for Industry. Part 11, Electronic Records; Electronic Signatures – Scope and Application (August 2003) • Guidance for Industry. Computerized Systems Used in Clinical Investigations (May 2007) • Documents with normative character • EMEA. Reflection on expectations for electronic source documents used in clinical trials. London, 17 October 2007 • Documents with recommendation • The draft “Implementation of Good Clinical Practice Software” by JM Lauritsen, University of Southern Denmark (02/2007) • The policy document of the German Coordinating Centres for Clinical Trials networks (October 23rd 2001, updated December 20th 2007) • Good Clinical Data Management Practice, Version 4, SCDM, October 2005 • Glossaries • Glossary in “Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95)” • CDISC Clinical Research Glossary, Version 6.0 • CDISC Acronyms, Abbreviations, and Initials, Version 6.0

30. http://ferran.torres.name/edu/caiber Gracias por vuestra atención!!