1. Large research and medical databases in clinical and research multi-centres trials 4th meeting of the EC International Dialogue on Bioethics Copenhagen, June 19, 2012 Dr Andreas Reis Ethics and Health

2. 4 th EC International Dialogue on Bioethics Copenhagen, June 19 th, 2012 Outline International Clinical Trials Registry Platform (ICTRP) Global Summit of National Ethics Committees, 26-28 September 2012, Carthage, Tunisia

3. 4 th EC International Dialogue on Bioethics Copenhagen, June 19 th, 2012 ICTRP is a global initiative that aims to make information about all clinical trials involving human beings publicly available. It was established in 2006 in response to demand from WHO's Member States through a World Health Assembly resolution, calling for… "a voluntary platform to link clinical trials registers in order to ensure a single point of access and the unambiguous identification of trials with a view to enhancing access to information by patients, families, patient groups and others."… The International Clinical Trials Registry Platform (ICTRP)

4. 4 th EC International Dialogue on Bioethics Copenhagen, June 19 th, 2012 It publishes the ICTRP Search Portal (205,000 records) –http://www.who.int/trialsearch collecting 20 items per record in English (Trial Registration Data Set)http://www.who.int/trialsearch –And the website http://www.who.int/ictrp (6 UN languages)http://www.who.int/ictrp It publishes International Standards for Clinical Trials Registration Future: Explore possibility to include information on ethical issues –Justification of placebo –Target population e.g. inclusion or exclusion of vulnerable groups –Expected benefits for the community The International Clinical Trials Registry Platform (ICTRP)

5. 4 th EC International Dialogue on Bioethics Copenhagen, June 19 th, 2012 It supports the WHO Registry Network –15 Primary Registries & Data Providers: Australia, Brazil, China, Republic of Korea, India, Cuba, EU, Germany, Iran, ISRCTN (UK), Japan, Netherlands, South Africa/PACTR, Sri Lanka, USA –3 Partner Registries: Germany 2, Hong Kong 1 It supports countries and regions –Potential new registries: EMRO, Philippines, Tanzania, Thailand, Russian Federation Additional services: Universal Trial Number (UTN), Webservices, Mobile website, Newsletter (650+), XML download, Bridging Collaboration: Overcome failure to Publish nEgative fiNdings (OPEN), Pan African Clinical Trial Alliance (PACTA) The International Clinical Trials Registry Platform (ICTRP)

6. 4 th EC International Dialogue on Bioethics Copenhagen, June 19 th, 2012 Data providers 2007 - 2012 USA UK Netherlands Germany Iran India Sri Lanka China Australia Japan Brazil Cuba Republic of Korea South Africa European Union

7. 4 th EC International Dialogue on Bioethics Copenhagen, June 19 th, 2012 Future data providers Thailand Tanzania

8. 4 th EC International Dialogue on Bioethics Copenhagen, June 19 th, 2012 WHO Central Database WHO Trial Registration Data Set Primary Registries and Data providers ICTRP Search Portal ICTRP Data Model Partner registries

9. 4 th EC International Dialogue on Bioethics Copenhagen, June 19 th, 2012 Search results http://www.who.int/trialsearch

10. 4 th EC International Dialogue on Bioethics Copenhagen, June 19 th, 2012 Global Summit of National Ethics Committees Since 1996, NECs meet every two years to discuss emerging ethical issues of global interest Regional meetings of NECs in the interim years: for ex. Mexico (October 2011); AFRO end 2012/2013 (tbc) As Permanent Secretariat, WHO was asked to establish working groups to prepare the next Summit: –research ethics –infectious diseases –Organ, tissue, and cell transplantation –biobanking

11. 4 th EC International Dialogue on Bioethics Copenhagen, June 19 th, 2012 Global Summit of National Ethics Committees The 9 th Summit will take place in Carthage, Tunisia 26-28 September 2012 You are all cordially invited! Registration at: http://www.9gsnec.tunisia2012.rns.tn/http://www.9gsnec.tunisia2012.rns.tn/

12. 4 th EC International Dialogue on Bioethics Copenhagen, June 19 th, 2012 Thank you Merci Gracias شكرا Спасибо reisa@who.int www.who.int/ethics