PACTR: first WHO-endorsed primary registry in Africa

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 in partnership with the Cochrane Infectious Diseases Review Group and the Cochrane HIV/AIDS Review Group 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.

Recently, attention has been paid to under-reporting and selective result publishing that comes from a clinical trial process that is largely unregulated. 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 May 2005, this call was endorsed by the 58th World Health Assembly, and then the International Committee of Medical Journal Editors (ICMJE) released a statement explaining that they would only publish the results of trials registered prospectively. In 2007, the ICMJE updated their statement so only trials registered on WHO-endorsed primary registers[1] would be published, making trial registration mandatory for publication in medical journals.

www.pactr.org

In order to develop the ATM into a registry that would cater to the needs of the continent, the World Health Organization (WHO) suggested that ATM expand its remit beyond its disease-specific scope. In June 2009, the Pan African Clinical Trials Registry was born out of this expanded remit; the registry now accepts clinical trial applications pertaining to all diseases throughout the African continent. Following the expansion of the registry, the WHO, in July 2009, granted PACTR Primary Registry Status, making PACTR the registry of choice for all trialists concerned with abiding by WHO and ICMJE guidelines. The PACTR is the first WHO-endorsed primary registry on the African continent. Thus, in order for a clinical trial’s information to reach the public, registration of the trial in a WHO-endorsed registry is necessary and now trialists in Africa can make use of a local registering body and system.

The PACTR aims to increase transparency and self-sufficiency among researchers who conduct clinical trials in Africa. The goal of the registry is to help harmonise the regulation, registration and ethics of clinical trials on the continent. As the first primary registry on the continent, PACTR wants to make its goal of networking clear, to reassure localised national registries that we do not intend to compete with their efforts, but rather hope only to foster collaboration and networking.

Amber Abrams
PACTR Project Manager

[1] Primary registry status is granted by the WHO only to registries that meet specific criteria for content. Criteria are separated into six categories, namely: content, quality and validity, accessibility, unique identification, technical capacity and administration, and all categories must be met in order to receive Primary Registry Status. WHO Primary Registries meet the requirements of the ICMJE which stipulate that in order to be published in a member journal registration is mandatory. Thus, registration with a WHO-endorsed primary registry is critical for dissemination of trial results.