View
848
Download
1
Category
Tags:
Preview:
DESCRIPTION
Babalwa Zani, Pan African Clinical Trials Registry speaking at Open Access Africa 2010
Citation preview
Babalwa Zani and Amber AbramsThe 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 Developing Countries Clinical Trials Partnership (EDCTP) for funding the initial start-up grant
Our partners and collaborators
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
““Wherever health care is provided and Wherever health care is provided and used, it is essential to know which used, 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 is and which are likely to be harmful. This is especially important in situations where especially important in situations where health problems are severe and the health problems are severe and the scarcity of resources makes it vital that scarcity 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.
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
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
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
Source: Googlemaps, created 1 November 2010 @2010 Google – Map data @2010 AND Geocenter Consulting and MapData Sciences, PTY Ltd, PSMA, MapLink, Tele Atlas
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
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
PACTR
African Vaccines Regulatory Forum
(AVAREF)
ICTRP
CONSOLIDATED
REPORTING OF TRIALS
GROUP (CONSORT)
PACTR Partners and CollaboratorsPACTR Partners and Collaborators
COHREDwww.healthresearchweb.org
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
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
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.
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
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
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
GhanaCameroon
7 – 10 trials
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
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 TB and HIV Malaria and HIV
Other
119
63 3
6
23
1612
4 4
14
Registered
Pending
Total *
0
10
20
30
40
50
60
70
80Ja
n. 2
008
Mar
chM
ayJu
lySe
ptem
ber
Nov
embe
rJa
n. 2
009
Mar
ch
May
July
Sept
embe
rN
ovem
ber
Jan.
201
0M
arch
May
July
Sept
embe
r
Tota
l Num
ber O
f Tria
ls
Growth By Month from 2008 - Present
* 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
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
To register your trial or for more information please contact us at:
Website: www.pactr.orgEmail: pactradmin@mrc.ac.za or
aabrams@mrc.ac.za Telephone: +27 21 938 0506
Fax: +27 21 938 0836
Recommended