Filling the Gaps: The World Health Organization and the Pan African Clinical Trials Registry efforts to combat an unclear child-focused clinical trial landscape

Article type
Authors
Abrams A1, Siegfried N2, Ghersi D3
1Pan African Clinical Trials Registry, South African Cochrane Centre, Tygerberg, Western Cape, South Africa
2Cochrane Centre, Medical Research Council of South Africa, Tygerberg, Western Cape, South Africa
3Research Policy and Cooperation, World Health Organisation, Geneva, Switzerland
Abstract
Background: Cochrane reviews of child-focused interventions regularly conclude that there is insufficient trial data in children. The World Health Organization (WHO) is co-ordinating a multi-regional initiative to increase clinical trial activity and registration involving children worldwide. The Pan African Clinical Trials Registry (www.pactr.org), based at the South African Cochrane Centre, provides a platform to prospectively register all clinical trials conducted in Africa. In 2009, in partnership with the WHO, www.pactr.org developed a Child Strategy to encourage prospective registration of African child-focused trials. Objectives: 1. To describe trials in children registered on www.pactr.org 2. To establish a baseline of registered trials recruiting children on PACTR to expedite future assessments of the Child Strategy Methods: We downloaded details of trials registered on www.pactr. org on 11 March 2010. Two independent investigators extracted trial data, including details of disease and participant ages. Results: Eleven of 23 (48%) registered trials research children s health. Of five trials in pregnant women, two evaluate drug prevention for malaria and one drug treatment, one evaluates anaesthesia for Caesarian Section, and one assesses patient advocacy for preventing mother-to-child HIV transmission. In infants, two trials evaluate HIV vaccines; in older children, one assesses antiretrovirals in HIV-infected children and one evaluates drug treatment for malaria. A trial promoting adherence via economic incentives includes children and adults with tuberculosis. A meningitis vaccine trial includes participants aged 1 to 29 years. Trial activity is present in 14 African countries (see map). Conclusions: The low number of registered trials on PACTR reflects the nascent stage of www.pactr.org, which has been a Primary Registry in the WHO Registry Network since September 2009. Encouragingly the proportion of child-focused trials is almost half of all registered trials. As www.pactr.org grows, free access to identify ongoing trials in Africa will develop the registry into a key continental information resource.