| Projects |
| Appropriate levels of oxygen saturation for extremely preterm infants: a prospective meta-analysis |
| Dr Lisa Askie, Professor John Simes |
| Five randomised trials will contribute individual patient data to a prospective meta-analysis of 5200 infants assessing the effects of different oxygen saturation targeting ranges in extremely preterm infants from birth. This project will involve the ongoing management of the collaborative group, and data collection and analysis. It will also include utility assessment modelling and assessing the effects of differing results scenarios with data and safety monitoring committees. |
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| Risk models for preventing and predicting pre-eclampsia |
| Dr Lisa Askie, Associate Professor Val Gebski |
| The PARIS individual patient dataset was collected from 31 randomised trials and over 32 000 women to assess the effects of antiplatelets in preventing pre-eclampsia. Risk modelling will be undertaken to assess the contribution of a variety of risk factors in preventing and predicting this disease. This will also include model validation and potential identification of new outcomes. |
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| Australian Placental Transfusion Study |
| Professor William Tarnow-Mordi, Dr Lisa Askie |
| Multicentre randomised controlled trial of placental transfusion by delayed cord clamping and cord milking in extremely preterm infants to assess the effects on death and major disability at two years' corrected age. |
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| Should preterm babies be delivered in warmer environments? A time cluster randomised controlled trial |
| Professor William Tarnow-Mordi, Dr Lisa Askie |
| Time-cluster randomised controlled trial of delivery into different ambient temperatures (<22C vs >27C) for extremely preterm infants and the effects on short- and long-term mortality and morbidity. |
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| INIS II |
| Professor William Tarnow-Mordi, Dr Lisa Askie |
| The International Neonatal Immunotherapy Study (INIS) is a major international double-blind placebo-controlled randomised trial testing the effects of immunoglobulin in newborn babies with serious infection. INIS II is a multicentre randomised controlled trial of pentoxifylline versus placebo in preterm infants with suspected late-onset sepsis (>7 days) and the effects on short- and long-term mortality and morbidity. |
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| Developing standards for prospective trial registration methods |
| Dr Lisa Askie, Professor John Simes |
| A series of projects are planned to assess and develop aspects of prospective trial registration methodology. These include assessing and optimising compliance with trial registration; assessing and minimising unintentional duplication both within and across registries, and mapping regional supports for enhancing trial registration, including ethical, legal and financial factors. |
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| Developing methods for furthering prospective meta-analysis |
| Dr Lisa Askie, Professor John Simes |
| Assessing and developing criteria for what constitutes a true prospective meta-analysis will be investigated via a series of related projects. This work will be undertaken in conjunction with the Cochrane Prospective Meta-analysis Methods Group, of which Dr Askie is a co-convenor. |
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| Risk models of cardiovascular disease |
| Professor John Simes |
| The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) trial was a long-term multicentre trial in cardiovascular disease, with 9014 patients. It showed that lipid lowering with pravastatin prevented recurrent coronary heart disease events. Patients have continued to be followed up since the trial finished in 1997. The database covers 15 years of follow-up. This project will look at the absolute benefits of risk reduction due to modifiable factors. |
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| Global risk models for cholesterol treatment |
| Professor John Simes |
| The investigators of 14 large cholesterol-lowering trials make up the Cholesterol Treatment Trialists' Collaboration, which is undertaking an international prospective meta-analysis of data from nearly 100 000 patients. Some results have been published, and the project is continuing. Opportunities are available to study: 1. global risk models related to cholesterol treatment; and 2. cost-effectiveness of treatment within the trial and beyond. |
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| Variations in risk in acute coronary syndromes |
| Professor John Simes |
| Projects look at variations in risk in patients with acute coronary syndromes, such as myocardial infarction, by disease category, outcome or region. |
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| Prognostic and predictive markers in breast cancer |
| Professor John Simes |
| The SNAC (Sentinel Node Biopsy versus Axillary Clearance) trial, with over 1000 patients, is the first large trial of surgical treatment of breast cancer in Australasia. This project is an investigation of prognostic and predictive biomarkers and other predictors of recurrence and survival in SNAC and other breast cancer trials. |
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| Symptoms, dysfunctions and quality of life in advanced cancer |
| Associate Professor Martin Stockler |
| The ZEST trial randomized 189 people with advanced cancer and troublesome anxiety, depression, fatigue or anergy to sertraline or placebo. Symptoms, dysfunctions and quality of life, were measured with several validated instruments including the Centre for Epidemiologic Studies Depression Scale, the Hospital Anxiety and Depression Scale, the FACT-G(eneral) and FACT-F(atigue), the Pt Disease and Treatment Assessment Form and the Utility-Based Questionnaire- Cancer. This aim of this project is to validate and optimise these patient-rated outcome measures for future trials in advanced cancer. |
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| Long-term follow-up of mortality in type 2 diabetes |
| Professor Anthony Keech |
| FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) trial, with 9795 patients in Australia, New Zealand and Finland, aimed to prevent cardiovascular events in patients with diabetes by using fenofibrate to modify blood lipids. The large database continues to be augmented by new data from follow-up of patients. Substudies to be undertaken include comparing older and younger patients and comparing men and women with respect to mortality. |
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| Biomarkers, genetic markers and cardiovascular risk in type 2 diabetes |
| Professor Anthony Keech |
| The FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) trial, with 9795 patients in Australia, New Zealand and Finland, aimed to prevent cardiovascular events in patients with diabetes by using fenofibrate to modify blood lipids. Blood samples from patients are being analysed for possible markers of risk. This project involves analysis of the results from the lab (not lab work). |
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| Genetic predictors of microvascular complications in type 2 diabetes |
| Professor Anthony Keech |
| The FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) trial, with 9795 patients in Australia, New Zealand and Finland, aimed to prevent cardiovascular events in patients with diabetes by using fenofibrate to modify blood lipids. Blood samples from patients are being analysed for predictors of kidney and eye disease in diabetes. This project involves analysis of the results from the lab (not lab work). |
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| Health burdens in Australians with type 2 diabetes |
| Professor Anthony Keech |
| The FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) trial, with 9795 patients in Australia, New Zealand and Finland, aimed to prevent cardiovascular events in patients with diabetes by using fenofibrate to modify blood lipids. This project looks at the health burdens and costs of type 2 diabetes. |
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| Applicating of penalised Cox models for adjustment of other-drug use in clinical trials |
| Professor Anthony Keech |
| This project looks at evidence-based adjustments of on-study treatments in clinical trials. |
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| Dynamic balanced randomisation |
| Professor Anthony Keech |
| Dynamic balanced randomisation is a sophisticated tool for allocating patients to groups in clinical trials. Further development of the method is continuing. |
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| Improving recruitment and adherence to treatment in clinical trials |
| Dr Wendy Hague |
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| Variation in trial design by outcomes: a simulation study |
| Professor John Simes |
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| Behaviour of co-primary outcomes: their influence on stopping rules and results |
| Professor Anthony Keech |
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| Contact: enquiry@ctc.usyd.edu.au or phone 61 2 9562 5000. |
