Babalwa Zani and Amber Abrams
The Pan African Clinical Trials Registry (www.pactr.org)
 Trial registrants
 BioMed Central and Computer Aid International for the
invitation to present today
 The European and...
 Introduction
 Clinical Trials Registration
◦ Why do we need them?
◦ How do researchers benefit from them?
 Who is invo...
““Wherever health care is provided andWherever health care is provided and
used, it is essential to know whichused, it is ...
A trials registry is a database in which key
administrative and scientific information
about planned, ongoing and complete...
 Reduce publication bias
 Fulfill researchers’ ethical obligation to participants
 Ensure transparency and can enhance ...
The 2004 Ministerial Summit on Health Research called on
the WHO to establish:
“a network of international clinical trial ...
Source: Googlemaps, created 1 November 2010
@2010 Google – Map data @2010 AND Geocenter Consulting and MapData Sciences, P...
 Access to the ICTRP is free, and publicly searchable
 Use of the ICTRP allows users a single point of access
to search ...
 www.pactr.org, as a member of the WHO Network of
Primary Registries, gives researchers in Africa the
opportunity to regi...
PACTR
African Vaccines
Regulatory Forum
(AVAREF)
ICTRP
CONSOLIDATED
REPORTING OF TRIALS
GROUP (CONSORT)
PACTR Partners and...
 www.pactr.org provides a resource for many stakeholders
◦ Policy Makers, Regulators and Ethics Review Boards
◦ Healthcar...
 Can provide transparency of process
◦ Collects information on ethics approvals and trial progress
◦ Can assist with stre...
 For healthcare professionals www.pactr.org is a resource for:
◦ tracking information on interventions for use on patient...
 For funders and sponsors, www.pactr.org is a resource for:
◦ understanding /locating present trial activity to inform gr...
 For researchers, www.pactr.org is a resource for:
◦ understanding and locating present trial activity
◦ determining wher...
 73 applications to the registry to date:
◦ 38 with registry numbers
◦ 9 incomplete
◦ 26 not eligible
The Gambia
Burkina ...
The Gambia
Burkina Faso
Nigeria
Gabon
South Africa
Egypt
1 - 2 investigators
3 - 4 investigators
5 - 6 investigators
Mali
...
Data: Trial Applications and StatusData: Trial Applications and Status
*Total numbers reflect all applications, including ...
0
10
20
30
40
50
60
70
80 Jan.2008
March
May
July
September
November
Jan.2009
March
May
July
September
November
Jan.2010
M...
* Our greatest accomplishment has been the growth of www.pactr.org
Publications
 Abrams, A and Siegfried N. "The Pan Afri...
 Ensure all trials are identified and trial information made widely
available in an open-access repository
 Assist in ha...
 To register your trial or for more information please
contact us at:
Website: www.pactr.org
Email: pactradmin@mrc.ac.za ...
Open access to clinical trials through prospective clinical trials registries
Open access to clinical trials through prospective clinical trials registries
Open access to clinical trials through prospective clinical trials registries
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Open access to clinical trials through prospective clinical trials registries

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Babalwa Zani, Pan African Clinical Trials Registry speaking at Open Access Africa 2010

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  • Thank you for the invitation and opportunity to attend this forum.
    Thank you to our funder, The European and Developing Countries Clinical Trials Partnership
    To the WHO ICTRP for their collaboration, and to WHO-AFRO and AVAREF for their continued support
    The PACT registry is led by the South African Cochrane Centre (SACC) based at the South African Medical Research Council (MRC) and the Cochrane Infectious Disease Group, based at the Liverpool School of Tropical Medicine, and was developed by a three-year funding grant from the European and Developing Countries Clinical Trials Partnership (EDCTP). It works in partnership with the Cochrane HIV/AIDS review group.
    Aside from the partners involved in the management of www.pactr.org and those already acknowledged our other collaborators include CONSORT, Australian and New Zealand Clinical Trials Registry, clinicaltrials.gov, and the South African Department of Health.
  • The 2007 updated statement explains that they would only publish the results of trials registered prospectively and that members of the WHO Network of Primary Registries meet their requirements
    Thus, trial registration is mandatory for publication in medical journals according to the International Committee of Medical Journal Editors (ICMJE). Without a registration number from a WHO-endorsed primary registry, results of the trial will not even be considered for publication in member journals.
  • The World Health Organizations International Clinical Trials Registry Platform (or ICTRP) is not a clinical trials registry but a platform that collects data from partner registries.
    WHO ICTRP
    is a platform facilitating prospective registration of a minimum 20-item data set
    advocates for the public availability of a minimum amount of result information from clinical trials
    harmonises and standardises the efforts of other registries around the world through their Registry Network
    provides a searchable portal of all clinical trials through the search portal
    This platform’s goals have guided the development of www.pactr.org into the first primary registry on the African continent
    The WHO Registry Network provides prospective trial registries with a forum to exchange information and work together to establish best practice for clinical trial registration.
    WHO Primary Registries need to meet certain criteria to ensure that the data collected meets the standards of the ICTRP.
    * For further information on these 6 areas please visit http://www.who.int/ictrp/network/criteria_summary/en/index.html
  • 11 members of the WHO network of primary registers
    Australian New Zealand Clinical Trials Registry (ANZCTR)   
    Chinese Clinical Trial Register (ChiCTR)   
    Clinical Research Information Service (CRiS), Republic of Korea  
    Clinical Trials Registry - India (CTRI)    
    German Clinical Trials Register (DRKS)    
    Iranian Registry of Clinical Trials (IRCT)  
    ISRCTN.org
    Japan Primary Registries Network (members: UMIN, JapicCTI, JMACCT)
    The Netherlands National Trial Register (NTR)     
    Pan African Clinical Trial Registry (PACTR)    
    Sri Lanka Clinical Trials Registry (SLCTR) 
    * To view individual registry profiles please visit :http://www.who.int/ictrp/network/primary/en/index.html
  • Our portal homepage
  • Since African trialists face additional challenges in trial registration, such as limited, unreliable and costly access to the internet, often African collaborators in multi-country clinical trials need to request their partners on other continents register the trial for them. Thus, as a registry designed by Africans for Africans, trials may be registered online, by email, postal mail or facisimile.
  • Partners and collaborators
    The PACTR is led by the South African Cochrane Centre (SACC) based at the South African Medical Research Council (MRC) and the Cochrane Infectious Disease Group, based at the Liverpool School of Tropical Medicine, and was funded through July 2010 by the European and Developing Countries Clinical Trials Partnership (EDCTP).
    Also, out of the meeting of the Southern African Development Community HIV/AIDS Research agenda development meeting came the formal endorsement of www.pactr.org (in the meeting minutes, but no formal announcement). We hope to further develop these budding relationships and forge more new relationships throughout the African region.
    The newest additions to our collaborations is our developing relationship with the Council on Health Research for Development (COHRED)
  • COHRED (The Council on Health Research for Development) runs www.healthresearchweb.org, an open source health information resource where we have posted links and profiles on our current projects. We will be adding a link from our site to COHRED in the next phase of the portal development.
  • In the next stages of our portal development (set to take place in the New Year) we will be adding a resource page so that visitors to our site can access other regional resources thus providing links to education and training
  • Read the slide
    Also for Ethics Review Boards (ERBs) or policy groups the registry can be a resource to see if a trial they are reviewing has been terminated in other locations or denied ethics approval
  • For Healthcare professionals (like clinicians, nurses, etc.) and their patients www.pactr.org can
    1. Track information on interventions for use on patients
    2. Provide information on ongoing research, or completed, unpublished trials to fill gaps in information
    3. Assist in locating trials to suggest to patients to participate in
    4. Assist in locating alternative treatments, or additional information on suggested treatments.
    Thus, the registry assists in information dissemination and knowledge translation on clinical trial work for access by consumers and their doctors.
  • www.pactr.org can assist Healthcare research funders and sponsors in
    1. Understanding /locating present trial activity to inform grant decisions
    2. Determining where research funding is needed to inform development of grant calls or setting research agendas
    3. Determining if proposals for research funding duplicates work already in progress
    4. Networking or research on other funding agencies
    The scaling-up of health services will be assisted by ensuring research topics are diversified and funding calls are need-appropriate
    Information translation is more precise and funds are saved through the use of www.pactr.org
  • Healthcare researchers
    1. Understanding and locating present trial activity
    2. Determining where research is needed
    3. Determining if planned research duplicates work already in progress
    4. Determining appropriate collaborators
    5. Networking
    The scaling-up of health services will be assisted by the networking opportunities provided by www.pactr.org
    Information sharing is encouraged and funds are saved through the use of www.pactr.org to ensure that researchers are not duplicating the efforts of others
  • This map is a visual representation of the trial work presently registered on www.pactr.org. Site users can search for information on trial in their area, or look up details of trials recruiting in their location.
  • The data from this map shows the location of African PIs – by searching the trial profiles on our site, users can located the contact information of PI s who may be conducting similar research
    38 Trials list 48 P.I.s because 2 trials list multiple P.I.s
    37 P.I.s are from African countries
  • The data on our site is concentrated on HIV/AIDS, Malaria and TB
  • Perhaps the greatest achievement of www.pactr.org in the last year has been the growth of the registry –
    it has nearly tripled since the formal launch at the last AVAREF meeting. At the end of September 2009 we had 25 applications to the registry and 11 registered trials, today we have 73 applications to the registry and 38 registered trials.
  • 5th African Vaccines and Regulatory Forum (AVAREF)
    The International Paediatric Association (IPA) Conference
    The Initiative to Strengthen Health Research Capacity in Africa (ISHReCA) General Meeting
    First Annual Regional Conference on Immunization (WHO-AFRO)
    5th Public Health Association of South Africa Conference 2009
    5th MIM Pan-African Malaria Conference
  • EDCTP funding cycle has come to a close. We have secured three years funding for salary costs and management of the registry, but are presently researching funding opportunities to continue our press, promotion and information dissemination efforts
  • Open access to clinical trials through prospective clinical trials registries

    1. 1. Babalwa Zani and Amber Abrams The Pan African Clinical Trials Registry (www.pactr.org)
    2. 2.  Trial registrants  BioMed Central and Computer Aid International for the invitation to present today  The European and Developing Countries Clinical Trials Partnership (EDCTP) for funding the initial start-up grant  Our partners and collaborators
    3. 3.  Introduction  Clinical Trials Registration ◦ Why do we need them? ◦ How do researchers benefit from them?  Who is involved? ◦ ICTRP ◦ www.pactr.org as an example  How do open access registries strengthen healthcare capacity?  Conclusions and future development
    4. 4. ““Wherever health care is provided andWherever health care is provided and used, it is essential to know whichused, it is essential to know which interventions work, which do not work,interventions work, which do not work, and which are likely to be harmful. This isand which are likely to be harmful. This is especially important in situations whereespecially important in situations where health problems are severe and thehealth problems are severe and the scarcity of resources makes it vital thatscarcity of resources makes it vital that they are not wasted”they are not wasted” Chinnock P, Siegfried N, Clarke M (2005) Is evidence-based medicine relevant to the developing world? PLoS Med 2(5): e107.
    5. 5. A trials registry is a database in which key administrative and scientific information about planned, ongoing and completed trials, sufficient to identify that trial’s existence, are stored
    6. 6.  Reduce publication bias  Fulfill researchers’ ethical obligation to participants  Ensure transparency and can enhance public trust in the conduct of clinical research  Increase participant enrollment in research trials  Reduce duplication of research  Encourage collaboration
    7. 7. The 2004 Ministerial Summit on Health Research called on the WHO to establish: “a network of international clinical trial registers to ensure a single point of access and the unambiguous identification of trials” In 2005 the above call was ◦endorsed by the 58th World Health Assembly ◦supported by the International Committee of Medical Journal Editors (ICMJE) In 2007 the ICMJE updated their statement ◦Registration mandatory for publication
    8. 8. Source: Googlemaps, created 1 November 2010 @2010 Google – Map data @2010 AND Geocenter Consulting and MapData Sciences, PTY Ltd, PSMA, MapLink, Tele Atlas
    9. 9.  Access to the ICTRP is free, and publicly searchable  Use of the ICTRP allows users a single point of access to search multiple partner registries  Links directly to local/regional registries  Through local/regional registries networks can be established, and health research capacity will benefit from resource and information sharing
    10. 10.  www.pactr.org, as a member of the WHO Network of Primary Registries, gives researchers in Africa the opportunity to register their trials with the registry of choice for the African region  Trial data contributes to global data on clinical trials through the ICTRP  www.pactr.org seeks to provide feasible ways of overcoming obstacles specific to African trialists  Registration is free, and information on registered trials is easy to search and free to access
    11. 11. PACTR African Vaccines Regulatory Forum (AVAREF) ICTRP CONSOLIDATED REPORTING OF TRIALS GROUP (CONSORT) PACTR Partners and CollaboratorsPACTR Partners and Collaborators COHRED www.healthresearchweb.org
    12. 12.  www.pactr.org provides a resource for many stakeholders ◦ Policy Makers, Regulators and Ethics Review Boards ◦ Healthcare professionals (like clinicians, nurses, etc.), researchers, research funders and sponsors ◦ Healthcare consumers  Supports harmonization and collaboration between nations  Raises regional awareness  Encourages education and training
    13. 13.  Can provide transparency of process ◦ Collects information on ethics approvals and trial progress ◦ Can assist with streamlining policy and ethics decisions ◦ Can assist policy makers in protecting their constituents  Can reduce duplication of efforts and can assist in reducing money and effort spent on reviewing proposed research  Can facilitate information sharing between review boards and regional policy makers
    14. 14.  For healthcare professionals www.pactr.org is a resource for: ◦ tracking information on interventions for use on patients ◦ information on ongoing research, or completed, unpublished trials to fill gaps in information ◦ locating trials to suggest to patients to participate in  For consumers www.pactr.org is a resource for: ◦ locating alternative treatments, or additional information on suggested treatments  Thus, the registry assists in information dissemination and knowledge sharing on clinical trial work for access by consumers and their doctors.
    15. 15.  For funders and sponsors, www.pactr.org is a resource for: ◦ understanding /locating present trial activity to inform grant decisions ◦ determining where research funding is needed to inform development of grant calls or setting research agendas ◦ determining if proposals for research funding duplicates work already in progress ◦ networking or research on other funding agencies  The scaling-up of health services will be assisted by ensuring research topics are diversified and funding calls are need-appropriate  Information sharing is encouraged and funds can be saved by using www.pactr.org
    16. 16.  For researchers, www.pactr.org is a resource for: ◦ understanding and locating present trial activity ◦ determining where research is needed ◦ determining if planned research duplicates work already in progress ◦ determining appropriate collaborators/funders ◦ networking
    17. 17.  73 applications to the registry to date: ◦ 38 with registry numbers ◦ 9 incomplete ◦ 26 not eligible The Gambia Burkina Faso Nigeria Gabon Zambia South Africa Mozambique Zimbabwe Tanzania Rwanda Kenya Uganda Ethiopia Guinea-Bissau Egypt Benin 1 – 2 trials 3 – 4 trials 5 – 6 trials Mali Malawi Ghana Cameroon 7 – 10 trials
    18. 18. The Gambia Burkina Faso Nigeria Gabon South Africa Egypt 1 - 2 investigators 3 - 4 investigators 5 - 6 investigators Mali Cameroon Malawi Ghana Kenya Ethiopia Uganda Zambia Guinea-Bissau Tanzania 7 - 8 investigators
    19. 19. Data: Trial Applications and StatusData: Trial Applications and Status *Total numbers reflect all applications, including those trials that were ineligible. Twenty-six applications were ineligible due to the study design being other than a clinical trial (8) or application was received post commencement of the trial (18). 0 5 10 15 20 25 HIV/AIDS Malaria TB TBand HIV Malariaand HIV Other 11 9 6 3 3 6 23 16 12 4 4 14 Registered Pending Total*
    20. 20. 0 10 20 30 40 50 60 70 80 Jan.2008 March May July September November Jan.2009 March May July September November Jan.2010 March May July September TotalNumberOfTrials Growth By Month from 2008 - Present
    21. 21. * Our greatest accomplishment has been the growth of www.pactr.org Publications  Abrams, A and Siegfried N. "The Pan African Clinical Trials Registry: Year one data analysis of the only African member of the World Health Organization Network of Primary Registries.“ Journal of Evidence Based Medicine, In Press.  Baleta, A. African Trials Registry Launches Child Strategy. The Lancet, 2010, 375. pp. 1423.  Abrams, A and Siegfried, N. A Pan-African Clinical Trials Registry for the specific needs of triallists on the continent. South African Medical Journal, 2010, 100(5): 294 -95. Presentations on www.pactr.org at the following conferences:  3 International conferences  3 Regional (continental conferences)  1 Southern African conference
    22. 22.  Ensure all trials are identified and trial information made widely available in an open-access repository  Assist in harmonising the efforts to regulate, register and review clinical trials on the African continent  Develop continental-wide awareness to create an environment that is friendly to, but also well educated on, clinical trial research  Maintain status and continue networking efforts with national or other registries to maintain the most thorough and comprehensive database of trial activity on the African continent  Secure future funding to ensure sustainability and free access to all
    23. 23.  To register your trial or for more information please contact us at: Website: www.pactr.org Email: pactradmin@mrc.ac.za or aabrams@mrc.ac.za Telephone: +27 21 938 0506 Fax: +27 21 938 0836
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