Trends in randomized controlled trials of malaria treatment and prophylaxis in Africa

Article type
Authors
Lutje V, Grober L, Garner P, Siegfried N
Abstract
Background: Ninety per cent of all malaria cases occur in sub-Saharan Africa, placing a major burden on children under five years and pregnant women. To effectively assess interventions to prevent or treat malaria, and to plan future research, stakeholders need information on trials completed, ongoing and planned. The ATM Registry (www.atmregistry.org), launched in 2007, is an African initiative that aims to address this need for information by providing a platform to prospectively register HIV/AIDS, tuberculosis and malaria trials conducted in Africa. The ATM Registry is funded by the European and Developing Countries Clinical Trials Partnership and includes a component of already concluded trials, which is used for the analysis presented here. Objectives: To identify and describe randomized controlled trials (RCTs) of malaria prophylaxis and treatment conducted partly or wholly in Africa on African participants (trials on travellers to Africa were excluded). To analyze the geographical and temporal distribution of the trials and their characteristics. Methods: In 2007, we ran systematic searches of electronic databases (MEDLINE, EMBASE, CENTRAL, LILACS) to identify malaria RCTs. We used the search strategy prepared by the Cochrane Infectious Diseases Group (CIDG) which incorporates the Cochrane Highly Sensitive Search Strategy for RCTs (Higgins, 2006). African trials were identified by applying a geographic search filter (Siegfried et al., 2005). We analyzed the distribution of trials by country and by decade and will further analyze trials conducted in the past 20 years for clinical characteristics, author’s affiliation and sources of funding. Results: We obtained 1814 records describing malaria trials between 1948 and 2007, of which 943 (51.9%) were reports of trials in Africa. There was a steady increase in the number of trials over time with higher numbers of trials conducted in Africa than in other regions since 2000 (Figure 1). Within Africa, the highest number of trials was conducted in Kenya, Tanzania and Nigeria (Figure 2). Further analysis is ongoing. Conclusions: The ATM Registry incorporates the rigorous search methods developed by the Collaboration and demonstrates the utility of maintaining databases of trials, such as that compiled by the CIDG, in specific fields.