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

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Mar

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Nov

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Mar

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May

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Jan.

201

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arch

May

July

Sept

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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