Co-Director of Cancer Trials, NHMRC Clinical Trials Centre, University of Sydney
Senior Lecturer in Cancer Medicine and Clinical Epidemiology, University of Sydney
Director, Cancer Trials NSW, The Cancer Council NSW
Medical Oncologist, Sydney Cancer Centre, Royal Prince Alfred Hospital and Concord Hospitals

These are exciting times. The last 30 years have seen major reductions in mortality from breast cancer, childhood leukaemia and testis cancer heralding what is possible for other cancers. These improvements are a direct result of clinical trials establishing the benefits of mammographic screening, adjuvant therapy, and treatments for advanced cancer and improving their effectiveness. Changes in community attitudes to sun exposure, tobacco use, and diet should cause major reductions in skin, lung, and colorectal cancer cancers over the next 30 years. Despite these major advances, about a quarter of people in the Western world will die from cancer, and many more will be affected. Why are clinical trials crucial to improving our lot?

Recent, rapid advances in cell biology, genetics, drug development, radiation biology and physics, surgery, supportive care and diagnostics have resulted in a plethora of promising new interventions against cancer. These promising new interventions have to be tried, tested and proven before they can be adopted in clinical practice. The history of medical science shows that only a precious few will translate into real improvements. Clinical trials are the only reliable way of determining the safety, activity and benefit of these promising new interventions.

The theme of this series is ‘How consumers, clinicians and researchers can initiate and participate in the best cancer trials’. Changes in the nature of scientific progress, government involvement, commercial interests, and regulatory requirements are forcing us all to rethink our roles in oncology research.

The authors were selected because of their involvement in innovative, successful projects with lessons that I thought were applicable beyond their particular area, to other areas of oncology and medicine. Authors were asked to focus on what was innovative and interesting for a general audience, and to highlight lessons applicable to cancer trials research in general. All authors made related presentations at the International Clinical Trials Symposium held at Darling Harbour, Sydney in 2002.

Alan Coates sets the scene by describing the benefits, beneficiaries and challenges of cancer clinical trials research. He concludes that cancer trials are a good buy for patients, doctors and society.

Sue Lockwood considers collaboration between consumers and clinician researchers using the example of breast cancer, and the effects of recent controversies surrounding hormone replacement therapy. She concludes with the suggestion that researchers provide a community information abstract, summarising the results of their studies for an informed lay audience.

Mark Rosenthal reflects on the strengths and innovations of the Victorian Centre for Developmental Cancer Therapeutics. The model has been so successful in cancer that it will be applied to neurological and cardiovascular diseases through the establishment of Clinical Trials Victoria, which recently received an $8 million grant from the Victorian Government.

Nicholas Wilcken describes the opportunities and challenges associated with Australia’s participation in HERA, a large international randomised trial of trastuzumab (Herceptin™). He concludes that studies like HERA raise new questions about how trials should be designed and conducted, and reinforce the need for conducting high quality clinical trials on which to base clinical practice.

Marie Malica describes the development of Cancer Trials NSW as a model for improving participation in and access to clinical trials. She emphasises the importance of collaboration, inclusion, consumer involvement and improving access and participation. She concludes that while much needs to be done, the future looks bright.

Leonie Young describes an innovative program to acknowledge the contributions of breast cancer trial participants by providing a network, education about breast cancer research and advocacy training. She concludes that increasing the community’s awareness of the benefits of breast cancer trials will also help other areas.

Life is getting more complicated, but major improvements are on offer. Many have argued, in Australia and overseas, that increasing participation and access to high-quality cancer trials is the best way to improve outcomes for people affected by cancer. Getting cancer trials on the local political agenda may be our major battle in the war against cancer. Perseverance may be the key to helping more Australians survive the war.

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