Ghassan Karam Project Manager ICTRP - WHO, Geneva
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1 Beirut, 2 June 2016 Ghassan Karam Project Manager ICTRP - WHO, Geneva 1
2 Outline Background ICTRP Network of countries Search Portal & Data model Statistics The Lebanese registry of clinical trials 2
3 What is the ICTRP? The International Clinical Trials Registry Platform (ICTRP) is a global initiative that aims to make information about all clinical trials involving human beings publicly available. 3
4 What is the ICTRP? It was established in 2006 in response to demand from countries through the World Health Assembly resolution that called 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" 4
5 ICTRP Values It is the position of the ICTRP that the registration of all interventional trials is a scientific and ethical responsibility. No position on Observational trials. Clinical trials must be registered in order to: improve transparency ensure greater accountability meet ethical obligations improve public trust prevent publication bias and selective reporting identify gaps in research facilitate the building of research infrastructure and capacity improve trial design, conduct and reporting prevent unnecessary duplication and encourage necessary replication improve health 5
6 What does it do? The ICTRP: Publishes the ICTRP Search Portal a web site and database that makes it is possible for anyone in the world to search, for free, data provided by clinical trial registries around the world that meet WHO criteria for content and quality Supports the WHO Registry Network a forum for Registries to exchange information and work together to establish international standards for clinical trial registration Supports countries and regions wanting to establish clinical trial registries or policies on trial registration. In some cases, these registries will be a catalyst for other capacity-building activity in clinical trial conduct and oversight - particularly ethical and regulatory oversight 6
7 CT Transparency Flow 7
8 Governance The ICTRP Secretariat Staff in HQ + focal points in ROs The ICTRP Advisory Group Established in August 2013 Gives advice to the Secretariat and to the management on policy issues related to Clinical trials and on new and existing primary registries 8 members (5 external and 3 from primary registries) 8
9 What is a Primary Registry? Meet criteria for content, quality, accessibility, unique identification, technical capacity and governance Managed by a not-for-profit agency Have the support of government within the country / region for the proposed Primary Register to act as the Primary Register for the country / Region Have the support of the International Committee of Medical Journal Editors (ICMJE) 9
10 ICTRP Registry Network USA Cuba Peru EU UK Netherlands Germany Iran China India Sri Lanka Republic of Korea Thailand Japan Brazil South Africa Australia & NZ 10
11 Process for becoming a Primary registry 1. Establish a national registry 1. Regulated ethics review 2. Regulated clinical trials 2. Fill a profile form 3. Fill an IT infrastructure form 4. Letter of support from the Ministry of Health 5. Successfully transfer data to ICTRP 6. Get reviewed by the ICTRP advisory panel 7. Get accreditation letter 11
12 International Standards For Clinical Trials Registration Currently known as WHO ICTRP Registry Criteria on the ICTRP website 1. Content (prospective, TRDS) 2. Quality and Validity (SOP, public audit trail) 3. Accessibility (24/7 registration and search, local language) 4. Unambiguous Identification (use sec ids for bridging) 5. Technical Capacity (xml transfer, IT) 6. Administration & Governance (national remit, Not-for profit) 12
13 Trial Registration Data Set - TRDS 1. Primary registry / Trial ID 2. Date of registration 3. Secondary ID 4. Source of support 5. Primary sponsor 6. Secondary sponsor 7. Contact (public) 8. Contact (scientific) 9. Public Title 10. Scientific Title 11. Countries of recruitment 12. Health Conditions 13. Interventions 14. Inclusion/Exclusion criteria 15. Study type 16. Date of first enrolment 17. Target sample size 18. Recruitment status 19. Primary outcomes 20. Secondary outcomes 13
14 Potential data providers for the future Spain Lebanon Mexico Tanzania Kenya Malaysia Singapore Indonesia 14
15 ICTRP Data Model Web Services & Crawling Services WHO Trial Registration Data Set Primary Registries and Data providers Central Database UMLS DTD, XML Search Portal Partner registries 15
16 Simple search 16
17 Advanced Search 17
18 List By Health Topic / Country 18
19 ICTRP Data by country of recruitment
20 Statistics from ICTRP EMRO region SAUDI PAKISTAN ARABIA 3% 4% EGYPT 10% LEBANON 2% Other 4% IRAN 77% Country Trials Iran: Egypt 1373 Saudi Arabia: 540 Pakistan: 424 Lebanon: 378 Other :
21 Statistics from ICTRP - Lebanon 33% are currently recruiting patients 80% interventional studies 70% sponsored by pharma 50% are Phase 3 50% are children related trials 378 Results found on 30/5/
22 Top Health Conditions - Lebanon Cancer 18% Diabetes 10% Other 60% Multiple Sclerosis 4% Sickle cell disease 3% Hypertension 3% Heart failure 2% 22
23 Top sponsors - Lebanon AUB 14% Novartis 12% Other 56% Merck 5% Bayer 5% GSK 4% Sanofi 4% 23
24 ICTRP website The ICTRP website is in all 6 official WHO languages: English, French, Spanish, Arabic, Chinese, Russian 24
25 ICTRP aspirational milestones A significant reduction in the gap between what we do and do not know about clinical trials, particularly those conducted in low and middle income countries. An increase in the number of countries with either their own national clinical trial registry (meeting WHO standards) or an enforceable policy that clinical trials be registered in a Primary Registry in the WHO Registry Network An improvement in the quality of registered data Clinical Trials results database 25
26 CT Transparency Flow Registration Results reporting Individual Patient Data Sharing (IPD) 26
27 WHO statement on results disclosure 27
28 The Lebanese Registry of Clinical Trials : LBCTR MoPH forms a committee for regulating clinical trials (decree 1398/1) MoPH meets with ICTRP / WHO in Geneva MoPH required submission of any clinical trials involving use of investigational products (decree 1159/1) MoPH establishes accreditation system to review IRBs (decree 2286/1) 28
29 The Lebanese Registry of Clinical Trials - LBCTR The LBCTR will publicly register all clinical trials conducted in Lebanon It will increase transparency, comparability and quality of clinical trials It will be accessible to the public, researchers and patients It will ensure patient safety and standardize the conduct of trials 29
30 Thank you شكرا
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