Dr Lisa Askie
PhD, MPH, BN|
Senior Research Fellow NHMRC Clinical Trials Centre
Phone: +61 2 9562 5000 |
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Projects |
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Australian Clinical Trials Registry (ACTR)Simes J, Ghersi D
Manager: Askie L Australasians can now find out which clinical trials are taking place in all areas of health: new drugs, treatments, therapies, surgical procedures and medical devices. With the establishment of the Australian New Zealand Clinical Trials Register (ANZCTR), we now have a comprehensive, on-line register of clinical trials being conducted in Australia and New Zealand. The National Health and Medical Research Council (NHMRC) and New Zealand Health Research Council, by funding the ACTR, is enabling Australian and New Zealand researchers to contribute to a worldwide initiative: to make public all clinical trials. The World Health Organization (WHO) has established a trials' registry portal, the International Clinical Trials Registry Platform (ICTRP) through which trials registers around the world can be accessed http://www.who.int/trialsearch The ANZCTR contributes data to this platform as one of the WHO's Primary Registries. Prior registration is also now a condition of publishing trials research. The International Committee of Medical Journal Editors (ICMJE, including editors of the Medical Journal of Australia, Lancet, and New England Journal of Medicine and others) will not publish the results of any clinical trials not included on a recognised register at the trial's inception. Knowing about all existing clinical trials will assist patients and practitioners to make more informed choices about trial participation. It will assist researchers in identifying gaps in their own research and help prevent unnecessary duplication. The ANZCTR can be accessed at: http://www.anzctr.org.au NeOProM Collaboration: a prospective, individual patient data meta-analysis assessing appropriate levels of oxygen stauration for extremely preterm infants
Despite oxygen being one of the most commonly used therapies in the care of small or sick newborns, uncertainty regarding the most appropriate levels of oxygenation for extremely preterm infants has existed for over 50 years. It remains unknown whether the anticipated short term benefits (such as reduced respiratory and ophthalmic morbidity) of targeting oxygen saturation levels generally "lower" from birth can be achieved without resulting in small, but important, increases in death and major disability rates for these vulnerable infants. The Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration has been formed to undertake a prospective individual patient data meta-analysis to answer this important clinical question. This approach is considered "gold standard" of systematic review methodology. It provides the same strengths as a single large-scale randomised trial, but provides greater pragmatic flexibility, especially regarding the different regulatory and recognition needs that arise when multiple funding sources are required. This will be the first prospective meta-analysis undertaken in neonatology. Several randomised trials of similar design are now being conducted worldwide. Together these trials plan to recruit approximately 5,200 infants which is a sufficient sample size to detect a difference in death and/or major disability of as little as 4%. A collaborative group was formed in 2003. The first participating trial commenced enrolment in 2005. Final results should be ready for presentation to, and discussion with, the NeOProM Advisory Group in 2012 with the main publication is expected soon thereafter. PARIS Collaboration: an individual patient data review of antiplatelets to prevent pre-eclampsiaHenderson-Smart D, Duley L, Stewart L, Askie L. There is now good evidence that antiplatelet agents (principally low dose aspirin) prevent pre-eclampsia, a leading cause of morbidity and mortality for pregnant women and their babies. A Cochrane Review identified moderate, but clinically important, reductions in the relative risks of pre-eclampsia (19%), preterm birth (7%) and perinatal mortality (16%) in women allocated antiplatelets, rather than placebo or no antiplatelet. Uncertainty remains, however, about whether some women (in terms of risk) benefit more than others, what dose of aspirin is best and when in pregnancy treatment should ideally start. Rather than undertake new trials, the best way to answer these questions is to utilise existing individual patient data from women enrolled in each trial by undertaking a systematic review with meta-analysis based on. The PARIS (Perinatal Antiplatelet Review of International Studies) Collaboration was formed to undertake the review. The objective was to confirm that antiplatelet agents, given during pregnancy, reduce the incidence of pre-eclampsia. The review found confirmed moderate, but statistically significant reductions, in adverse outcomes for both mother and their babies in women taking antiplatelets compared to placebo. However, there was no evidence that any particular group of 'at risk' women benefited more or less from antiplatelet therapy. This was the first individual patient data review in the perinatal field. Primary results were published in The Lancet in 2007. ACT On-lineBarratt A, Tattersall M, Askie L, Crossing S, Butow P, Currow D, McGeechan K. This project will build and evaluate a website, Australian Cancer Trials On-line which will enable people affected by cancer to quickly and easily search for patients cancer clinical trials which are currently open and for which they may be eligible anywhere in Australia. The website will contain up-to-date information about currently open cancer clinical trials so that consumers can search for trials about specific cancer types, cancer stages and cancer treatments. Cancer consumers have been advocating for such a website for some years and this projects enjoys strong professional and consumer organization support. Use of the website will be evaluated in a cluster randomized in NSW and Victoria. The project is a collaboration between CeMPED, the Australian and New Zealand Clinical Trials Registry and Cancer Australia. |
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