Tracking The Impact Of Drug Regulatory Actions: Consumer Health Outcomes, Risk-benefit Issues And Policy Framework.
Funder
National Health and Medical Research Council
Funding Amount
$439,324.00
Summary
This study will explore what happens in the community when a medicine is withdrawn from the market or discredited due to safety concerns. It will examine the impacts of two recent cases of medicine withdrawal or serious long-term safety concern, on a large cohort of women with high utilisation rates who were monitored during the time the medicines were discredited. The study will be an important guide to future regulatory, media and provider responses when medicines are discredited.
Value Of Androgen Deprivation And Bisphosphonate In Patients Treated By Radiotherapy For Localised Prostate Cancer
Funder
National Health and Medical Research Council
Funding Amount
$2,533,827.00
Summary
Following on from significant findings in the TROG 96.01 trial, the 03.04 trial, known as the RADAR trial was developed. This is a large-scale randomised controlled clinical trial currently conducted at 23 cancer treatment centres throughout Australia and New Zealand. The RADAR trial aims to recruit 1000 men with localised but inoperable prostate cancer. It was anticipated that the length of time required to enrol 1000 participants to the trial would be 5 years. However, because enrolment has ex ....Following on from significant findings in the TROG 96.01 trial, the 03.04 trial, known as the RADAR trial was developed. This is a large-scale randomised controlled clinical trial currently conducted at 23 cancer treatment centres throughout Australia and New Zealand. The RADAR trial aims to recruit 1000 men with localised but inoperable prostate cancer. It was anticipated that the length of time required to enrol 1000 participants to the trial would be 5 years. However, because enrolment has exceeded expectations and 728 patients have already been recruited, it is anticipated that the recruitment target will be reached in mid 2007. Patients are randomly assigned to receive one of four treatment options in the RADAR trial. The first option: Option A: Radiation Therapy and 6 months of Hormone Therapy (Leuprorelin acetate), is currently the standard of care. Option C is a further 12 months of hormone therapy after the current standard of care. Two of the options (B and D) are identical to options A and C except that subjects also receive 18 months of zoledronate (a 'bone' drug) in addition to hormone therapy and radiotherapy. The main goal of the RADAR trial is to determine whether 12 months of hormone therapy using Leuprorelin acetate starting immediately after standard therapy (ie 6 months of Leuprorelin acetate before and during radiotherapy) will reduce risk of return of the cancer, either within the prostate region or at remote sites in the body, and prolong life. An additional goal is to see whether 18 months of bisphosphonate therapy (bone density therapy) using zoledronate will reduce the risk of cancer returning in the bones as well as stopping dangerous bone thinning which can sometimes be caused by hormone therapy. The trial also seeks to determine whether the additional therapy given in this trial alters quality of life.Read moreRead less
Optimal Duration Of Neoadjuvant Androgen Deprivation Therapy In Localised Prostate Cancer Treated By Radiotherapy
Funder
National Health and Medical Research Council
Funding Amount
$422,335.00
Summary
The 96.01 trial aims to find out whether androgen deprivation (AD) administered prior to and during radiotherapy (i.e., neo-adjuvant AD) will improve outcomes in patients with locally advanced prostate cancer that is considered inoperable and is treated for cure by radiotherapy. The trial also aims to find out whether six months AD produces outcomes superior to those achieved by three months AD. The trial has been running since 1996 and involves 802 men who attend 19 cancer treatment centres acr ....The 96.01 trial aims to find out whether androgen deprivation (AD) administered prior to and during radiotherapy (i.e., neo-adjuvant AD) will improve outcomes in patients with locally advanced prostate cancer that is considered inoperable and is treated for cure by radiotherapy. The trial also aims to find out whether six months AD produces outcomes superior to those achieved by three months AD. The trial has been running since 1996 and involves 802 men who attend 19 cancer treatment centres across Australia and New Zealand. It would not have been possible without the continuous funding support of the NHMRC. So far this trial has shown that AD does prevent prostate cancer from returning after radiotherapy. This is very important because the need for treatment of recurrent cancer (usually AD for the rest of the patient's life) is halved by 6 months AD compared to standard treatment (radiotherapy alone). However, it is now necessary to observe the patients in this trial for another 5 years to find out whether AD also prolongs life, and whether 6 months AD is more effective than 3 months. Further patient follow up is also necessary to identify whether some men respond better to treatment than others. This is very important because it will enable treatment to be tailored to individual patients, in particular those who require more treatment than is given in this trial. This funding application is therefore to enable patient follow up on this large scale trial for another 5 years.Read moreRead less
Centre Of Research Excellence In Medicines And Ageing
Funder
National Health and Medical Research Council
Funding Amount
$2,601,415.00
Summary
Medicines have an important place in health and are commonly used for long periods, sometimes life-long. Using medicines wisely requires a careful balance between benefits and harmful effects. Currently, there is limited information to guide medicines use over a lifetime. Using large linked datasets, the CRE in Medicines and Ageing will generate much needed evidence about real world medicines use to support clinical and pharmaceutical policy decisions.
The Intended and Unintended Impact of Policy for Adaptive Policy Management. The project aims to advance knowledge about the intended and unintended consequences of policy on health and well-being. It expects to innovate through new methods and novel data to integrate policy evaluation into the policy cycle in a timely fashion to prevent harm from occurring. It also leverages technology to track policy effects in real time. Expected outcomes of this project include new knowledge and enhanced pol ....The Intended and Unintended Impact of Policy for Adaptive Policy Management. The project aims to advance knowledge about the intended and unintended consequences of policy on health and well-being. It expects to innovate through new methods and novel data to integrate policy evaluation into the policy cycle in a timely fashion to prevent harm from occurring. It also leverages technology to track policy effects in real time. Expected outcomes of this project include new knowledge and enhanced policy infrastructure using new methods and interdisciplinary approaches. Significant benefits include improvements to: (1) policy management by government departments; (2) the health and wellbeing of the Australians they serve; (3) our Partners' capacity to consult governments on how technology can assist policy management. Read moreRead less
Equitable funding for health care: integrating social outcomes. This project will develop an innovative method for decision makers to achieve more equitable allocation of scarce health care resources. Health programs and treatments affect not just health (survival & health related quality of life) but also broader aspects of well-being (e.g. dignity, autonomy, safety). Our current methods for evaluating value for money in health do not capture these aspects. The project will provide benefit by a ....Equitable funding for health care: integrating social outcomes. This project will develop an innovative method for decision makers to achieve more equitable allocation of scarce health care resources. Health programs and treatments affect not just health (survival & health related quality of life) but also broader aspects of well-being (e.g. dignity, autonomy, safety). Our current methods for evaluating value for money in health do not capture these aspects. The project will provide benefit by allowing health system decision makers to achieve fairer allocation of resources across diverse health conditions, interventions and patient populations. Expected outcomes include a new tool for assessing interventions and measuring population health incorporating both health and social outcomes. Read moreRead less
Optimal Duration Of Neoadjuvant Androgen Deprivation Therapy In Localised Prostate Cancer
Funder
National Health and Medical Research Council
Funding Amount
$275,000.00
Summary
Each year approximately 8000 men in Australia and New Zealand develop prostate cancer which has not spread widely and which is amenable to attempted cure by surgery or radiation. Prostate cancer depends for its growth on the male hormone, testosterone, which circulates in the blood. As a result treatment which reduces testosterone level ('androgen deprivation' [AD] therapy) can produce shrinkage of prostate cancer. In fact AD has caused temporary but valued relief to millions of men with cancer ....Each year approximately 8000 men in Australia and New Zealand develop prostate cancer which has not spread widely and which is amenable to attempted cure by surgery or radiation. Prostate cancer depends for its growth on the male hormone, testosterone, which circulates in the blood. As a result treatment which reduces testosterone level ('androgen deprivation' [AD] therapy) can produce shrinkage of prostate cancer. In fact AD has caused temporary but valued relief to millions of men with cancer of the prostate that has spread throughout the body for the last five decades, worldwide. It remains uncertain however whether AD administered before surgery or radiation will benefit any of the 8000 men each year who develop localised cancer by shrinking the cancer first. In 1996 a trial involving 800 men across Australia and New Zealand commenced under the auspices of the Trans-Tasman Radiation Oncology Group (TROG) to answer the questions: 1 - Does either 3 or 6 months AD prior to radiotherapy reduce the chances of recurrence of the cancer after radiotherapy? 2 - Does such therapy reduce the volume of tissue requiring radiotherapy and hence the chances of long term side effects after radiotherapy? This grant will support collection of follow-up information from the trial and hence answers to the questions asked.Read moreRead less
Improving teacher assessment using exemplars and online moderation. This project aims to assess the dependability of teacher judgement using psychometric scaling and online moderation. The project will use an innovative approach to connect achievement standards and judgement-practice for middle-year students in Australian education system. Expected outcomes of the project include the development of scaled work samples exemplifying A-E standards of achievement, refined methods for the consistency ....Improving teacher assessment using exemplars and online moderation. This project aims to assess the dependability of teacher judgement using psychometric scaling and online moderation. The project will use an innovative approach to connect achievement standards and judgement-practice for middle-year students in Australian education system. Expected outcomes of the project include the development of scaled work samples exemplifying A-E standards of achievement, refined methods for the consistency and comparability of assessment decisions, and a new approach to moderating teacher judgements. This project should provide significant benefits in building teachers’ assessment capabilities, shaping policy and teacher preparation.Read moreRead less
A cross-national study of the relative impact of an oral component on PhD examination quality, language and practice. High quality doctoral degrees call for the most effective forms of assessment. This project investigates the role of oral examination in PhD assessment, common internationally but not in Australia, and is the first to compare the relative impact of oral and 'no oral' models on examination quality, language and practice.
Developing An Australian Valuation For The EQ-5D-5L Quality Of Life Instrument
Funder
National Health and Medical Research Council
Funding Amount
$348,357.00
Summary
In the assessment of gains resulting from a health technology, it is standard to consider both mortality and quality of life effects. This project explores how Australians value different components of quality of life. To do this, we are running an online survey called a discrete choice experiment, and analysing the data using a range of cutting-edge econometric techniques. This will allow policy-makers to better reflect people's preferences when making decisions about new technologies.