Research Report 2006–2007

The National Health and Medical Research Council Clinical Trials Centre conducts its own clinical trials, provides expertise and infrastructure for trials run by other groups, and undertakes research aiming to improve both the conduct of trials and the resulting clinical evidence. Since 1988, when the CTC was set up as a research centre at the University of Sydney, over 60 000 patients have been randomised into its trials. Currently, around 40 active trials — in cancer, cardiovascular disease and neonatology — are being conducted in collaboration with networks of clinical investigators across Australia and elsewhere. The CTC has played a leading role in establishing some of these investigator groups, most recently the Cooperative Trials Group for Neuro-Oncology and the Australasian Lung Cancer Trials Group. Trial investigators also participate in international collaborations to carry out prospective meta-analysis of data from concurrent clinical trials. For example, the NeOProM collaboration has been formed by five cooperating trial groups, involving over 5000 patients, with leadership from the CTC. Developments such as this increase the effi ciency of research and the validity of its fi ndings, resulting in benefi t to patients throughout the world. The CTC also has strong links and partnerships withgovernment and nongovernment organisations and industry. Projects include capacity building for Australian health and research, reviews of evidence to assist government policy making, and methodological research. The CTC’s past research has served the Australian population well, particularly through reduced cardiovascular disease and deaths from heart disease and improved survival and better quality of life for patients with many types of cancer. This report covers the CTC’s achievements for the biennium, 2006–2007

Research Report 2011

The NHMRC Clinical Trials Centre (CTC) at the University of Sydney runs large multicentre investigator-initiated clinical trials, takes part in trials of national and international collaborative trial groups and contributes expertise to trials run by others. It also: • takes a lead in proposing new directions for trial research in Australia, particularly with regard to integrating clinical trials with national policy and clinical practice • leads, coordinates and participates in national and international research collaborations • undertakes methodological research in relation to clinical trials and biostatistics • reviews and synthesises evidence from completed trials, and is at the forefront of developments in methods, such as prospective meta-analysis • advises on trial design and operation, and randomises patients and analyses data for other groups conducting trials • offers postgraduate supervision in all of these areas • offers a postgraduate program in clinical trials research by distance education • runs short courses in the design and conduct of clinical trials as part of its undertaking to train people for Australian medical research. Core funding is provided by the National Health and Medical Research Council (NHMRC),and specific projects are funded by government, public and private institutions and the pharmaceutical industry. The CTC is at two sites in Camperdown in inner Sydney — the Medical Foundation Building on Parramatta Road and on Mallett Street. This report covers the CTC’s achievements for 2011

Research Report 2010

The NHMRC Clinical Trials Centre at the University of Sydney conducts large multicentre investigator-initiated clinical trials, takes part in trials of national and international collaborative trial groups and contributes expertise to trials run by others. It also: • takes a lead in proposing new directions for trial research in Australia, particularly with regard to integrating clinical trials with national policy and clinical practice • undertakes methodological research in relation to clinical trials • reviews and synthesises evidence from completed trials and is at the forefront of developments in methods, such as prospective meta-analysis • advises on trial design and operation, and randomises patients and analyses data for other groups conducting trials • offers postgraduate supervision in all of these areas • offers a postgraduate program in clinical trials research by distance education • runs short courses in the design and conduct of clinical trials as part of its undertaking to train people for Australian medical research Core funding is provided by the NHMRC, and specific projects are funded by government, public and private institutions and the pharmaceutical industry. The CTC is at two sites in Camperdown in inner Sydney — the Medical Foundation Building on Parramatta Road and on Mallett Street. This report covers the CTC’s achievements for 2010

Research Report 2004–2005

The National Health and Medical Research Council Clinical Trials Centre has the purpose of improving outcomes in health through clinical trials research. It was established by the National Health and Medical Research Council in 1988 as a research centre at the University of Sydney. The CTC provides the knowledge and infrastructure to ensure the quality, timely completion and reporting of clinical trials. It has vast expertise in the design, conduct and analysis of randomised controlled trials, particularly in cancer and cardiovascular disease. Over 100 staff have specialised skills, taking in clinical trials design, biostatistics, database design, randomisation and drug distribution, outcome assessment, quality assurance, and regulatory and ethical issues. In the past 16 years, the CTC has participated in more than 50 investigatorinitiated, collaborative-group clinical trials and coordinated some of the largest randomised trials initiated by Australian investigators (LIPID and FIELD studies, each with over 9000 patients). Over 40 000 patients have been randomised to these trials. All clinical trials undertaken through the CTC are conducted strictly according to guidelines for clinical trials research and conduct, and are audited by sponsors, the CTC itself and regulatory authorities. The CTC has a history of working collaboratively with cooperative groups, clinical trial networks and other organisations, and has played a central role in establishing some of these groups. These activities have been recognised in increased grant funding to enable further collaboration and to increase the number of investigator-initiated trials in Australia. In its research, the CTC has prospered: it has developed strategies for patient recruitment, trial and data management, study coordination, information systems and randomisation in an environment of academic excellence. In addition to trials management, the CTC is a leader in biostatistical methodology and analysis and in systematic review of health evidence. The integrated expertise of the CTC staff is turned to good use in frequent educational activities in Australia and elsewhere. This report covers the CTC’s achievements for the biennium, 2004–2005

Advancing Pediatric Antibacterial Drug Development: A Critical Need to Reinvent our Approach.

The Clinical Trials Transformation Initiative convened with several groups in the pediatric antibacterial drug development community with the goal of identifying challenges and recommending ways to improve current practice. Attention to 5 major areas hold the promise of making new antibiotics available for use in children as soon as possible after they are approved for use in adults

Stem cell clinical trials

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Do current clinical trials in cystic fibrosis match the priorities of patients and clinicans? A systematic review

There are many uncertainties regarding Cystic Fibrosis (CF) treatment. Recently, the first James Lind Alliance (JLA) Priority Setting Partnership (PSP) in CF was completed, bringing clinicians, patients and carers together to identify the Top 10 research priorities. Here we investigate how well the current clinical trials landscape reflects these priorities. Trials in CF were identified through searches of research databases (Pubmed, ANZCTR, EU clinical trials register, ClinicalTrials.gov and ISRCTN). Trials meeting inclusion criteria of registered intervention studies in CF published between 01.012016 and 11.09.2017 were matched to the Top 10 priorities. We identified 259 trials, with 193 fulfilling the inclusion criteria. Only 63 (33%) of these matched one or more of the JLA priorities showing that current clinical trials poorly reflect the JLA Top 10. By increasing awareness of the Top 10 priorities, it is hoped that this will fuel future research in areas important to the CF community

Incentives for Clinical Trials

Who gains from more information on the quality of pharmaceutical drugs? Are there incentives for voluntary post-approval clinical trials among pharmaceutical companies? Contrary to popular belief, this paper shows that it is not in the consumer interest that clinical evidence establishing the relative effectiveness within a class of drugs are produced. Pharmaceutical companies, on the other hand, do benefit: the elimination of uncertainty regarding quality increases expected product differentiation, thereby raising prices for both high-quality and low-quality drugs, to the disadvantage of consumers. Still there is no unique equilibrium where the market provides clinical trials. If the costs of carrying out clinical trials are small, in relative terms, there will be a coordination problem between firms, as firms will want a rival firm to carry the cost. If the costs are large they will be prohibitive. Legislation that obligates entering firms to carry out post-approval trials is beneficial for firms if it solves the coordination problem, but is otherwise harmful. Legislation is never in the interest of consumers.Quality uncertainty; Symmetric information; Pharmaceutical market; Clinical trials

Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT

The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT