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OBJECTIVE: To describe the frequency and design of controlled clinical trials specifically addressing the health needs of Aboriginal Australians. METHODOLOGY: Electronic searching of Medline, the Australasian Medical Index, the Aboriginal and Torres Strait Islander health bibliographic database, and handsearching of Aboriginal Health: an annotated bibliography. Studies that met the following selection criteria were included: i) addressed an Aboriginal health problem, ii) had a formal description of methods and results, and iii) compared the health effects of an intervention with a concurrent control group. All summary data were extracted by a single author. RESULTS: Only 13 studies were identified. Nine were randomised controlled trials and four were controlled trials but not randomised. Only one of these involved adults, which is unexpected. Although important Aboriginal child health issues were addressed in 12 of the 13 studies, most were undertaken many years ago and may not be familiar to Australian paediatricians. The majority appeared to be designed appropriately. Interestingly, the two studies not published in the medical literature had the largest sample size. There is no evidence that the number of published clinical trials involving Aboriginal Australians is increasing, or that long-term applied clinical research programmes have been established. CONCLUSION: There is a profound lack of well-designed studies assessing medical interventions. This is further evidence that Australia has failed to develop a research infrastructure able to inform health care in Aboriginal communities. Adults appear especially disadvantaged.
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