PRESS RELEASE: WHO provides primary status to the Pan African Clinical Trials Registry in Africa

The Pan-African Clinical Trials Registry (PACTR) has been accepted as a primary clinical trials registry – the first World Health Organization (WHO) endorsed trials registry in Africa. This registry will feed data into the global WHO International Clinical Trials Registry Platform (ICTRP) search portal facilitating African representation in the global picture of planned, ongoing and completed clinical trials. The Registry is currently funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and coordinated by the South African Cochrane Centre (SACC) at the Medical Research Council (MRC).

“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.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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