Introduction. Paolo G. Casali
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1 Introduction Paolo G. Casali
2 rare diseases
3 rare diseases rare cancers cancer
4 rare cancers
5 Rare cancers childhood
6 Rare cancers childhood haematological
7 Rare cancers childhood haematological solid of the adult
8 Eur J Cancer 2011;47:2493 RARE CANCERS 1. Pediatric cancers 2. Haematologic rare neoplasms 3. Sarcomas 4. Rare thoracic cancers 5. Neuroendocrine tumours 6. Head & neck cancers 7. Central nervous system tumours 8. Rare female genital cancers 9. Rare urological and male genital tumours 10. Endocrine gland tumours 11. Digestive rare cancers 12. Rare skin cancers & non-cutaneous melanoma
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14 rare diseases rare cancers cancer
15 Deliverables
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17 will provide highly specialised healthcare for rare or low prevalence complex diseases or conditions
18 promote good quality and safe care to patients by fostering proper diagnosis, treatment, follow-up and management of patients across the Network empower and involve patients offer and promote multi-disciplinary advice for complex cases develop and implement clinical guidelines and cross-border patient pathways exchange, gather and disseminate knowledge, evidence and expertise within and outside the Network promote collaborative research within the Network reinforce research and epidemiological surveillance, through setting up of shared registries exchange and disseminate knowledge and best practices, in particular by supporting national centres and networks
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21 Objectives With regard to RCs in the EU, to improve: 1. Epidemiological surveillance 2. Quality of care through ERNs 3. Clinical practice guidelines 4. Innovation 5. Medical and Patient education 6. Health policy measures 7. Patient empowerement
22 WP Work packages 1 Coordination INT, IT 2 Dissemination NKUA, GR 3 Evaluation CSF, FI 4 Epidemiology INT, IT 5 Assuring Quality of Care OECI 6 Clinical practice guidelines DKG, DE 7 Innovation and access to innovation WIV-ISP, BE 8 Medical education SZTE, HU 9 Childhood Cancers SIOPE 10 Rare Cancer Policy ICO, ES
23 18 MSs 34 ass. partners
24 Collaborating partners European Cancer Patients Coalition (ECPC) University College of London-Institute of Child Health (UCL-ICH) European School of Oncology (ESO) European Medicine Agency (EMA) European Network of Cancer Registry (ENCR) Joint Research Centre (JRC) Belgian Cancer Registry (BCR) Italian National Institute of Health (Istituto Superiore di Sanità) European Society for Medical Oncology (ESMO) Istituto Superiore di Sanità (ISS - Rare Best Practice) European Organisation for Research and Treatment of Cancer (EORTC) Anticancerfund Association of European Cancer Leagues (ECL) European Society of Surgical Oncology (ESSO) Childhood Cancer International (CCI-Europe) St. Anna Children's Cancer Research Institute (CCRI) Rare Cancer Europe (RCE) EFPIA-EuropaBio University of Milan Hospital Universitario y Politécnico La Fe. GICT-Cáncer IIS La Fe, (CICT)
25 .
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27 17. Call for increased integration of local, national and European centres of expertise into European reference networks, based on specific criteria as set out in the Commission s proposed Directive on the application of patients rights in cross-border healthcare, in order to provide the necessary sound organisational structures for more efficient clinical research and early transfer of research data into clinical practice, thus improving the clinical management of rare cancers.
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29 Networking: medical workload!
30 Networking
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34 Clinical decision-making Methods to combine evidence New study designs Surrogate end points Organization of studies
35 London, October 3 rd 2014
36 Researchers Pharma
37 Researchers Pharma Regulators
38 Researchers Patients Pharma Regulators
39 London, April 30 th 2015
40 London, June 30 th 2016
41 Martinalbo J et al ESMO 2016
42 Martinalbo J et al ESMO 2016
43 Martinalbo J et al ESMO 2016
44 Prospective clinical data bases / observational studies
45 «Big clinical data»
46 Ann Oncol 2014;25:1458
47 The «one-time consent» One time consent
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49 N Engl J Med 1987;316:250
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51 Post-graduate Master on Clinical Oncology of Rare Adult Solid Cancers
52 @casali_pg
Paolo G. Casali Annalisa Trama
Paolo G. Casali Annalisa Trama Objectives With regard to RCs in the EU, to improve: 1. Epidemiological surveillance 2. Quality of care through ERNs 3. Clinical practice guidelines 4. Innovation 5. Medical
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