Africa

Pan African Clinical Trials Registry (PACTR)

Presidente
Amber Abrams

Nombre del administrador de la organización o persona de contacto
Amber Abrams (aabrams@mrc.ac.za)

Número de teléfono: +27219380506

Número de fax: +27219380836

Dirección postal
Francie van Zijl Drive (physical address), Parrow Valley PO Box 19070, Tygerberg, 7505 (postal address) 7505 Cape Town, Western Cape

País
Africa

URL de la institución
www.pactr.org

The Pan African Clinical Trials Registry (www.pactr.org)

The Pan African Clinical Trials Registry (PACTR) was initiated in early 2007 as the AIDS, TB and Malaria (ATM) Clinical Trials Registry. The project is funded by the European and Developing Countries Clinical Trials Partnership and is being managed by the South African Cochrane Centre at the Medical Research Council. The intention of the project was to test the concept of a registry that would cater to the specific needs of African trialists.
 

A clinical 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. Increasingly attention is being paid to under-reporting and selective result publishing that comes from a clinical trial process that is largely un-regulated. In 2004, the Ministerial Summit on Health Research called on the WHO to establish networks that could provide a single access point for identifying trials. In 2005, this call was endorsed by 58th World Health Assembly and then, the International Committee of Medical Journal Editors (ICMJE) released a statement of support. In 2007, the ICMJE updated their statement so that only trials prospectively registered on WHO-endorsed primary registers would be published, making trial registration mandatory for publication in medical journals.
 

In order to develop the ATM into a registry that would cater to the needs of the continent, the African Vaccine and Regulatory Forum (AVAREF) supported by the World Health Organization (WHO) recommended that ATM expand its remit beyond its disease-specific scope. In June 2009, the Pan African Clinical Trials Registry was borne out of this expanded remit; the registry now accepts clinical trial applications pertaining to all disease throughout Africa. In July 2009, the PACTR became the first and only WHO-endorsed Primary Registry on the continent. Now trialists in Africa can make use of a local registering body and system.
 

The PACTR aims to increase transparency and self-sufficiency amongst national regulatory bodies to encourage the monitoring of clinical trial conduct in Africa. Researchers who conduct clinical trials in Africa face challenges that others may not (for example, expensive or undependable internet access) which the PACTR is attempting to combat by offering alternative options for registration. The goal of the registry is to help harmonise the regulation, registration and ethics of clinical trials on the continent and assist trialists in following ethical protocol. As the first primary registry on the continent, the PACTR will work with national registries assisting in the establishment of their systems and other related endeavours.
 

The PACTR is also participating in a WHO initiative to increase registration of child-focused trials throughout the world. Over the next three years the South African Cochrane Centre will gather information on key actors that attend to children's health on the continent. Using the PACTR, a prospective database of child-focused trials will be developed. We will map past trial activity to assess the child-focused trial landscape on the continent. This three-year project will culminate in a collaborative conference where invited stakeholders will convene to discuss the future objectives in maintaining high levels of trial registration, particularly in research on children.
 

www.pactr.org is supported by input from the South African Cochrane Centre and the Cochrane Infectious Diseases Group.

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
Contact Person: Amber Abrams, PACTR Project Manager
Telephone: +27 21 938 0506/0834
Fax: +27 21 938 0836
 

Child health and clinical trials in Africa - The Child Strategy

In synergy with the broader scope of clinical trials registration, www.pactr.org has embarked on a new project to develop a strategy to achieve the increased registration of clinical trials recruiting children in Africa. This is part of a larger World Health Organization initiative to increase registration and activity of child-focused trials throughout the world. Over the next three years the South Africa Cochrane Centre will gather information on key actors and networks that attend to children's health on the continent. With the help of these key players and networks, we will establish a list of organizations, conferences and venues to disseminate the strat