The Pan African Clinical Trials Register (PACTR_: Compliance with the WHO minimum data-set in the first Pan African WHO-endorsed Primary Registry
Amber Abrams, South African Cochrane Centre at MRC
1 October 2009
In the article “Compliance of clinical trial registries with the World Health Organization minimum data set : a survey” Moja et. al. explains that in September 2004, the International Committee of Medical Journal Editors (ICMJE) proposed “comprehensive trials registration as a solution to the problem of selective awareness and announce[d] that all 11 ICMJE member journals will adopt a trials-registration policy to promote this goal” (http://www.icmje.org/clin_trial.pdf). Thus, clinical trials must be publicly registered before the first participants are enrolled if the intention of the investigators is to publish findings in a medical journal.
To this end and to increase transparency and provide local registration opportunities for researchers who conduct clinical trials in Africa, the South African Cochrane Centre (SACC), based at the South African Medical Research Council, established a clinical trials registry for trials on HIV/AIDS, tuberculosis and malaria in 2007 (ATM Clinical Trials Registry). Since June 2009, this registry has expanded to contain clinical trials on all diseases, transitioning from the ATMCTR to the Pan African Clinical Trials Registry (PACTR). The PACTR is funded by the European and Developing Countries Clinical Trials Programme (EDCTP) and is managed in partnership with the Cochrane Infectious Disease Review Group and the Cochrane HIV/AIDS Review Group.
According to Moja et.al., although the World Health Organization (WHO) has created a mandatory minimum data-set as a means of standardizing available information “individual registry entries are largely incomplete”. Thus, the WHO has developed criteria by which a working group reviews applications of trial registries, and only after a stringent review to ensure all minimum standards are met, do they endorse a registry. Gaining a WHO primary status endorsement is a lengthy process as their working group is often developing new minimum standards leaving applicants for primary registry status responsible to meet these changing standards – this ensures that those registries with WHO endorsement are rigorous in their review of applications to their registries, and do not accept trials with incomplete data-sets.
Thus, the PACTR’s application to the WHO for primary status has been an ongoing process which was successful in June 2009 with the announcement that the PACTR“has been accepted by the Assistant Director General of the Information, Evidence and Research cluster” as a primary trials registry. PACTR 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. Researchers conducting clinical trials in Africa who use PACTR as their registry of choice will now meet international requirements for research transparency.
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 subsequent 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, reducing the likelihood of duplicated research and wasted funding and man-power (http://www.icmje.org/clin_trial.pdf).
The intention is for PACTR to become the single reference point for clinical trials activities in Africa feeding directly into the global WHO International Clinical Trials Search Portal, ensuring African representation in this global search engine. Additionally, 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 localized registries (Grobler et al, 2008:1201 – 1202). To learn more about PACTR or to register a trial, please visit our website at www.pactr.org.
Citation: Grobler L, Siegfried N, Askie L, Hooft L, Tharyan P, Antes G. 2008. “Are national and multinational prospective trial registers necessary?” The Lancet, Oct 4;372(9645): pp. 1201-2.
Competing interests
This response was written by Amber Abrams and Nandi Siegfried (PACTR Project Manager and PACTR Project Supervisor respectively) of the South African Cochrane Centre (SACC) at the MRC. PACTR is a European and Developing Countries Clinical Trial Partnership (EDCTP) funded project run out of the SACC.
Trials
The Pan African Clinical Trials Register (PACTR_: Compliance with the WHO minimum data-set in the first Pan African WHO-endorsed Primary Registry
1 October 2009
In the article “Compliance of clinical trial registries with the World Health Organization minimum data set : a survey” Moja et. al. explains that in September 2004, the International Committee of Medical Journal Editors (ICMJE) proposed “comprehensive trials registration as a solution to the problem of selective awareness and announce[d] that all 11 ICMJE member journals will adopt a trials-registration policy to promote this goal” (http://www.icmje.org/clin_trial.pdf). Thus, clinical trials must be publicly registered before the first participants are enrolled if the intention of the investigators is to publish findings in a medical journal.
To this end and to increase transparency and provide local registration opportunities for researchers who conduct clinical trials in Africa, the South African Cochrane Centre (SACC), based at the South African Medical Research Council, established a clinical trials registry for trials on HIV/AIDS, tuberculosis and malaria in 2007 (ATM Clinical Trials Registry). Since June 2009, this registry has expanded to contain clinical trials on all diseases, transitioning from the ATMCTR to the Pan African Clinical Trials Registry (PACTR). The PACTR is funded by the European and Developing Countries Clinical Trials Programme (EDCTP) and is managed in partnership with the Cochrane Infectious Disease Review Group and the Cochrane HIV/AIDS Review Group.
According to Moja et.al., although the World Health Organization (WHO) has created a mandatory minimum data-set as a means of standardizing available information “individual registry entries are largely incomplete”. Thus, the WHO has developed criteria by which a working group reviews applications of trial registries, and only after a stringent review to ensure all minimum standards are met, do they endorse a registry. Gaining a WHO primary status endorsement is a lengthy process as their working group is often developing new minimum standards leaving applicants for primary registry status responsible to meet these changing standards – this ensures that those registries with WHO endorsement are rigorous in their review of applications to their registries, and do not accept trials with incomplete data-sets.
Thus, the PACTR’s application to the WHO for primary status has been an ongoing process which was successful in June 2009 with the announcement that the PACTR“has been accepted by the Assistant Director General of the Information, Evidence and Research cluster” as a primary trials registry. PACTR 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. Researchers conducting clinical trials in Africa who use PACTR as their registry of choice will now meet international requirements for research transparency.
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 subsequent 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, reducing the likelihood of duplicated research and wasted funding and man-power (http://www.icmje.org/clin_trial.pdf).
The intention is for PACTR to become the single reference point for clinical trials activities in Africa feeding directly into the global WHO International Clinical Trials Search Portal, ensuring African representation in this global search engine. Additionally, 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 localized registries (Grobler et al, 2008:1201 – 1202). To learn more about PACTR or to register a trial, please visit our website at www.pactr.org.
Citation:
Grobler L, Siegfried N, Askie L, Hooft L, Tharyan P, Antes G. 2008. “Are national and multinational prospective trial registers necessary?” The Lancet, Oct 4;372(9645): pp. 1201-2.
Competing interests
This response was written by Amber Abrams and Nandi Siegfried (PACTR Project Manager and PACTR Project Supervisor respectively) of the South African Cochrane Centre (SACC) at the MRC. PACTR is a European and Developing Countries Clinical Trial Partnership (EDCTP) funded project run out of the SACC.