Filled Gaps? Data after a year of the Pan African Clinical Trials Registry efforts to increase understanding and awareness of the child-focused clinical trial landscape

Article type
Authors
Abrams A1
1South African Cochrane Centre, South Africa
Abstract
Background: Cochrane reviews of child-focused interventions often find that trial data in children is insufficient to draw conclusions. In 2009, the Pan African Clinical Trials Registry (www.pactr.org) in partnership with the World Health Organization developed a Child Strategy as part of a multi-regional initiative to increase child-focused clinical trial activity and registration worldwide. www.pactr.org, based at the South African Cochrane Centre, provides prospective registration for all clinical trials conducted in Africa.

Objectives: To describe trials affecting child-health registered on www.pactr.org.

Methods: We downloaded details of trials registered on www.pactr.org on 11 April 2011. A single investigator extracted trial data including details of disease, trial intention (prevention, treatment, etc.) and participant ages.

Results: 23 of 46 (50%) registered trials investigated topics that affect child health. Of nine trials in pregnant women, five researched malaria (three evaluated drug prevention; two treatment), one assessed patient advocacy for preventing mother-to-child HIV transmission, and three researched diseases other than HIV or malaria (one evaluated anaesthesia for Caesarian Section, one {post-partum hemorrhage treatment, and one, progesterone for unexplained infertility). In infants, two trials evaluated HIV vaccines. Of 9 trials in older children, three assessed antiretrovirals in HIV-infected children, four researched malaria (two evaluated drug treatment, one vaccine and one, post malaria anemia treatment), one assessed Tuberculosis treatment efficacy and another, the use of electronic decision making tools. A trial promoting adherence via economic incentives for TB, one analyzing malaria prevention, and one evaluating a meningitis vaccine included children and adults. Compared to last year’s baseline data there is a slight increase (from 48% to 50%) in the overall profile of child-focused trials registered. Child-focused trial activity is present in 19 African countries (an increase from last year’s 14; see map).

Conclusions: Continued efforts of the Child Strategy, to encourage child-focused trial research and registration in the region, will ensure www.pactr.org’s value as a research tool for those affiliated with the Cochrane Child Health Field.