PRNewswire - September 25, 2009

"We are delighted to be able to offer access to a WHO primary register to all trialists in Africa. We hope the PACTR will become the first choice for African trial registration," says Nandi Siegfried, co-director at the SACC.

In September 2004, the International Committee of Medical Journal Editors (ICMJE) stated that all 11 member journals would adopt a registration policy to promote comprehensive trial registration as a solution to the problem of selective awareness (http://www.icmje.org/clintrial.pdf). Thus clinical trials must be publicly registered before the first participants are enrolled if the intention is to publish findings in member medical journals which include leading journals such as The Lancet, JAMA and NEJM.

Professor Charles Mgone, EDCTP Executive Director, explained that since June 2009 the African registry has expanded from a disease-specific registry to cater for clinical trials on all diseases transitioning to the PACTR. Researchers conducting clinical trials in Africa who use PACTR as their registry of choice will meet international requirements for research transparency.

Davina Ghersi, head of WHO's International Clinical Trials Registry Platform (ICTRP), says the approval of PACTR as a primary trials registry is a significant milestone in the quest for transparency. "Our hope is that the PACTR will make it easier to capture information about trials involving people in the region. We look forward to filling the gap in our knowledge about clinical trials in Africa."

Since registries "provide an essential tool to assess completeness of the information about all initiated trials" and are the "necessary first step to enable identification of all trials" and the "tracking of their results" (Moja et.al., http://www.trialsjournal.com/content/10/1/56), having an African based registry will benefit both Africa and the world as PACTR will actively encourage trial registration.

"Registering a clinical trial greatly increases exposure of the trial and assists researchers in determining gaps in research, thus reducing the likelihood of duplication of research and wasted funding and man-power," says Professor Charles Mgone.

Dr Siegfried further says that it is the intention for PACTR to become the single reference point for clinical trials activities in Africa. "The registry will feed directly into the global WHO International Clinical Trials Search Portal, thus ensuring African representation in this global search engine".

Additionally, the PACTR's database will include regularly downloaded information from the South African National Clinical Trials Registry (SANCTR) and will continue to build information sharing networks with national or other localised registries.

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Background information:

In response to the need to increase transparency and facilitate registration by African researchers, the HIV/AIDS, Tuberculosis and Malaria (ATM) Clinical Trials Registry was first established in 2007.

African trialists face additional challenges in trial registration, such as limited, unreliable and costly access to the internet. Quite often, African collaborators in multi-country clinical trials need to request their partners on other continents to register the trial for them. Because of these obstacles, there is serious underreporting of clinical trials that are conducted on the African continent.

The PACTR seeks to provide feasible ways of overcoming these. It is a registry which is developed by Africans for Africans. Trials may be registered online (via the internet if access is sufficiently reliable) but they may also be registered by email, postal mail or facsimile. Registration is free, and information on registered trials is free of charge and easy to access through the registry's search function.

For more information please contact:

EDCTP - Ilona van den Brink (Communications Officer)

Tel.: +31-70-3494422 (office) | Mob.: +31-6-20689948 | Email: media@edctp.org

MRC - Julian Jacobs (MRC Corporate & Public Affairs Directorate Division Manager)

Tel.: +2721 9380241 (office) | Mob.: +27824544902 | Email: Julian.Jacobs@mrc.ac.za

PACTR at MRC - Amber Abrams (PACTR Administrator)

Tel.: travelling, can be reached through Ilona van den Brink, +31-6-20689948 | Email: aabrams@mrc.ac.za

Important links

PACTR online http://www.pactr.org

WHO ICTRP Search Portal http://www.who.int/ictrp/search/en

ICMJE www.icmje.org

Source: World Health Organization (WHO)

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