Large research and medical databases in clinical and research multi-centres trials 4th meeting of the EC International Dialogue on Bioethics Copenhagen,

Large research and medical databases in clinical and research multi-centres trialsLarge 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

4th EC International Dialogue on BioethicsCopenhagen, June 19th, 2012

OutlineOutline

International Clinical Trials Registry Platform (ICTRP)

Global Summit of National Ethics Committees,

26-28 September 2012, Carthage, Tunisia


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)


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)– And the website http://www.who.int/ictrp (6 UN languages)

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



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)



Data providers 2007 - 2012Data providers 2007 - 2012

USA

UKNetherlands

Germany

Iran

India

Sri Lanka

China

Australia

Japan

Brazil

Cuba

Republic of

Korea

South Africa

European Union


Future data providersFuture data providers

Thailand

Tanzania


WHO Central Database

WHO Trial Registration Data Set

Primary Registries and Data providers

ICTRP Search Portal

ICTRP Data ModelICTRP Data Model

Partner registries


Search resultsSearch resultshttp://www.who.int/trialsearch


Global Summit of National Ethics CommitteesGlobal Summit of National Ethics CommitteesSince 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


Global Summit of National Ethics CommitteesGlobal Summit of National Ethics Committees

The 9th Summit will take place in Carthage, Tunisia

26-28 September 2012

You are all cordially invited!

Registration at: http://www.9gsnec.tunisia2012.rns.tn/


Thank you

Merci

Gracias

شكرا

Спасибо

谢谢

[email protected]

www.who.int/ethics

Large research and medical databases in clinical and research multi-centres trials 4th meeting of the EC International Dialogue on Bioethics Copenhagen,

Documents

th ec international

th summit

bioethics copenhagen

international standards

health slide

tunisia slide

clinical trials registers

research multicentres