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

1. Babalwa Zani and Amber Abrams
The Pan African Clinical Trials Registry (www.pactr.org)

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.  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. ““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. 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.  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. 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

9. Source: Googlemaps, created 1 November 2010
@2010 Google – Map data @2010 AND Geocenter Consulting and MapData Sciences, PTY Ltd, PSMA, MapLink, Tele Atlas

10.  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

12.  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

13. PACTR
African Vaccines
Regulatory Forum
(AVAREF)
ICTRP
CONSOLIDATED
REPORTING OF TRIALS
GROUP (CONSORT)
PACTR Partners and CollaboratorsPACTR Partners and Collaborators
COHRED
www.healthresearchweb.org

15.  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

16.  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

17.  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.

18.  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

19.  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

20.  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

21. 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

22. 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*

23. 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

24. * 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

25.  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

26.  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