OECD/WHO Consultation on Xenotransplantation Surveillance: Summary

WHO/CDS/CSR/EPH/2001.1

저자:

Elettra Ronchi; OECD Working Party on Biotechnology,; World Health Organization. Department of Communicable Disease Surveillance and Response,; World Health Organization,

출판사:

[Geneva] : World Health Organization, [2001]

Transplantation, Heterologous -- Congresses.
Clinical Trials as Topic -- Congresses.
Communicable Diseases -- epidemiology -- Congresses.

N1553_WHO_CDS_CSR_EPH_2001.1.pdf

관련링크 1 : http://www.who.int/zoonoses/resources/xenotransplantation/en/

관련링크 2 : http://www.worldcat.org/title/oecdwho-consultation-on-xenotransplantation-surveillance-summary/oclc/857277590&referer=brief_results

유형 : 컨퍼런스 간행물, 문서, 정부 간행물, 세계적 정부 간행물, 인터넷 자료

This report summarises the topics, issues and considerations discussed at the OECD/WHO Consultation on Xenotransplantation Surveillance. The Consultation was held in Paris at OECD Headquarters on 4-6 October 2000 and was attended by over 60 participants from around the world, representing countries currently hosting xenotransplantation clinical trials; countries not actively engaged in xenotransplantation research but interested in its potential public health impact; and relevant international bodies such as the Council of Europe and the European Commission. The purpose of the Consultation was to bring together epidemiologists, infectious disease specialists, clinicians, industry, government and international organisation representatives and others working in public health and xenotransplantation research to discuss and exchange ideas on the desirability of and possible approaches to xenotransplantation-associated infectious disease surveillance, both at country level and internationally

[목차]

NOTE BY THE SECRETARIAT ...2

EXECUTIVE SUMMARY ...4

KEY SUMMARY POINTS ...6

1. Introduction ...8

2. Surveillance Issues in Xenotransplantation ...9
What is xenotransplantation? ...9
2.1 Developing a case definition for a xenogeneic infection or disease
event - do we need a new paradigm? ...9
What tools are there to discover novel syndromes? Can the traditional
paradigm of surveillance apply? ...10
2.2 Surveillance from a virologist's perspective ...10
2.3 Existing surveillance systems as potential models for
xenotransplantation ...11
2.3.1 Pharmacosurveillance systems: the European Union Drug
Regulatory Authorities Network ...11
2.3.2 Clinical trial surveillance systems: expedited reporting ...14
2.3.3 Examples of current surveillance strategies in industry-sponsored
xenotransplantation clinical trials ...16
2.3.4 Infectious disease surveillance systems ...17
3. Ethical considerations in xenotransplantation surveillance ...20

4. Tools and characteristics desirable for xenotransplantation
surveillance ...22
4.1 The specialised issues of early detection and response ...22
4.2 Rapid communication: the Canadian GPHIN ...23
4.2.1 The WHO outbreak verification process ...23
4.3 Databases and registries: the US National Xenotransplantation
Database ...25

5. Developing a concept framework for international xenotransplantation
surveillance ...27
5.1 The need for international xenogeneic infection and disease event
surveillance ...27
5.2 General attributes of international surveillance ...28
5.3 A network as a possible framework for international
xenotransplantation surveillance ...28
5.3.1 The peripheral network level ...29
5.3.2 The intermediate network level ...30
5.3.3 The central or country-wide network level...30
5.3.4 The international network level ...31

6. Results from Working Group discussions on international
xenotransplantation surveillance ...32

7. Consultation conclusions and recommendations ...34

APPENDIX I PROGRAMME AND LIST OF PARTICIPANTS ...37
APPENDIX II PRESS RELEASE ...51