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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.
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