Towards a more realistic picture of clinical trials in Africa (PACTR)
Posted by Ilona van den Brink on 11 October 2009 at 09:45
By Ochieng’ Ogodo
Underreporting of clinical trials conducted in Africa is a serious problem, leading to wasteful duplication of research. According to Amber Abrams, the Pan-African Clinical Trials Registry (PACTR) project manager for the South African Cochrane Centre at the Medical Research Council, the lack of coordinated regulation and ethical oversight of clinical trials in Africa largely accounts for this scenario. “National governments, in particular, need to coordinate and harmonise their regulatory efforts. Until now, there was no registry that collected data throughout the continent, but with PACTR having a World Health Organization (WHO) primary status endorsement, local governments have a resource available. We are hoping that they will encourage trialists in their countries to make use of PACTR especially since registering trials with registries that meet international standards is mandatory if you want to publish your trials in the member journals of the International Committee of Medical Journal Editors (ICJME) such as The Lancet, British Medical Journal and New England Journal of Medicine,” she said. Although various countries in Africa have their own ethics review boards and regulatory bodies, there has been no standardisation of legislation – it’s country by choice. According to Amber the PACTR is filling a gap that existed and is offering a register database where key administrative and scientific information about planned, ongoing and completed trails, sufficient to identify that trial’s existence, are stored. The World Health Organization (WHO) has created a mandatory minimum data-set as a means of standardising key information on clinical trials-separated into six categories, namely, content, quality and validity, accessibility, unique identification, technical capacity and administration. All trials that are registered through a WHO primary register comply with this data-set, thus facilitating finding, evaluating and comparing trial results. The clinical trial data-sets included in the PACTR feed into the International Clinical Trials Registry Platform (ICTRP) global clinical trials search portal. Up until now, WHO estimated that only 2% of all trials on their platform took place in Africa, but with the Pan-African Clinical Trials registry (PACTR) the hope is that a more realistic picture of trials taking place on the continent will be reflected. “It provides a source of reliable information on the efficacy and safety of prevention and treatment measures,” Abrams said adding that, “it identifies research gaps that should be addressed in future trials.” PACTR is an African initiative serving the needs of Africans. “PACTR allows researchers in Africa to register their trials with the registry of choice for the African region by providing feasible ways of overcoming obstacles specific to African trialists. We want to provide all stakeholders with a service. PACTR offers trialists alternatives to online registration such as registering through fax or regular post, and it offers free and open access to our search engine for all interested parties,” Abrams stated. Possible trial participants are able to access the PACTR website (www.pactr.org) to learn about interventions that they may want to participate in, while for policy makers and legislative bodies it is a resource giving them insight into whether trials have been conducted elsewhere. The transformation of the AIDS, Tuberculosis and Malaria (ATM) registry into the PACTR was a response to recommendations of the African Vaccine Regulatory Forum (AVAREF) meeting held in Zanzibar in 2008. Since June 2009, the PACTR has expanded significantly to contain clinical trials on all diseases.
Filed Under: Monday, Preparations
