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Cancer Forum Cancer Forum March 2003 Volume 27 Number 1 ISSN 0311-306X List of Contents Forum: Clinical trials Overview 3 M Stockler Clinical trials: Benefits and challenges 4 A Coates We’ve got a groovy thing goin’ baby … or have we? Involving women in clinical trials 5 S Lockwood Maximising opportunities for clinical research: The Centre for Developmental Cancer Therapeutics 7 MA Rosenthal HERA – new lessons from a new trial 8 N Wilcken Cancer Trials NSW: A collaborative initiative to support and promote cancer clinical trials research in NSW 9 M Malica Australian New Zealand Breast Cancer Trials Group: IMPACT 11 L Young Articles Testing for familial cancer susceptibility gene mutations 13 A Rowland, N Breheny, J Goldblatt , I Walpole, P O’Leary The impact of physiotherapy intervention on functional independence and quality of life in palliative patients 15 EL Laakso, AJ McAuliffe, A Cantlay Reports Support for research 2003 21 From bench to bedside and back again: COSA 29th Annual Scientific Meeting 30 Clinical trials: An open forum for consumers 31 Australian Behavioural Research in Cancer 32 News and Announcements 37 Book Reviews 41 Calendar of Meetings 47 F Clinical trials: How consumers, clinicians ORUM and researchers can initiate and participate in the best cancer trials OVERVIEW M Stockler Clinical Trials Symposium held at Darling Harbour, Sydney in 2002. Co-Director of Cancer Trials, NHMRC Clinical Trials Centre, University of Alan Coates sets the scene by describing the benefits, Sydney beneficiaries and challenges of cancer clinical trials research. Senior Lecturer in He concludes that cancer trials are a good buy for patients, Cancer Medicine and doctors and society. Clinical Epidemiology, University of Sydney Sue Lockwood considers collaboration between consumers and clinician researchers using the example of breast cancer, Director, Cancer Trials NSW, The Cancer Council NSW and the effects of recent controversies surrounding hormone Medical Oncologist, Sydney Cancer Centre replacement therapy. She concludes with the suggestion Royal Prince Alfred Hospital and Concord Hospitals that researchers provide a community information abstract, Camperdown, NSW summarising the results of their studies for an informed lay audience. These are exciting times. The last 30 years have seen major Mark Rosenthal reflects on the strengths and innovations of reductions in mortality from breast cancer, childhood the Victorian Centre for Developmental Cancer Therapeutics. leukaemia and testis cancer heralding what is possible for The model has been so successful in cancer that it will be other cancers. These improvements are a direct result of clinical applied to neurological and cardiovascular diseases through trials establishing the benefits of mammographic screening, the establishment of Clinical Trials Victoria, which recently adjuvant therapy, and treatments for advanced cancer and received an $8 million grant from the Victorian Government. improving their effectiveness. Changes in community attitudes to sun exposure, tobacco use, and diet should cause major Nicholas Wilcken describes the opportunities and challenges reductions in skin, lung, and colorectal cancer cancers over associated with Australia’s participation in HERA, a large the next 30 years. Despite these major advances, about a international randomised trial of trastuzumab (Herceptin™). quarter of people in the Western world will die from cancer, He concludes that studies like HERA raise new questions about and many more will be affected. Why are clinical trials crucial how trials should be designed and conducted, and reinforce to improving our lot? the need for conducting high quality clinical trials on which to Recent, rapid advances in cell biology, genetics, drug base clinical practice. development, radiation biology and physics, surgery, supportive care and diagnostics have resulted in a plethora of promising Marie Malica describes the development of Cancer Trials new interventions against cancer. These promising new NSW as a model for improving participation in and access to interventions have to be tried, tested and proven before they clinical trials. She emphasises the importance of collaboration, can be adopted in clinical practice. The history of medical inclusion, consumer involvement and improving access and science shows that only a precious few will translate into participation. She concludes that while much needs to be real improvements. Clinical trials are the only reliable way of done, the future looks bright. determining the safety, activity and benefit of these promising new interventions. Leonie Young describes an innovative program to acknowledge the contributions of breast cancer trial participants by The theme of this series is ‘How consumers, clinicians and providing a network, education about breast cancer research researchers can initiate and participate in the best cancer and advocacy training. She concludes that increasing the trials’. Changes in the nature of scientific progress, government community’s awareness of the benefits of breast cancer trials involvement, commercial interests, and regulatory requirements will also help other areas. are forcing us all to rethink our roles in oncology research. Life is getting more complicated, but major improvements are The authors were selected because of their involvement in innovative, successful projects with lessons that I thought on offer. Many have argued, in Australia and overseas, that were applicable beyond their particular area, to other areas of increasing participation and access to high-quality cancer trials oncology and medicine. Authors were asked to focus on what is the best way to improve outcomes for people affected by was innovative and interesting for a general audience, and to cancer. Getting cancer trials on the local political agenda may highlight lessons applicable to cancer trials research in general. be our major battle in the war against cancer. Perseverance All authors made related presentations at the International may be the key to helping more Australians survive the war. 2 Cancer Forum n Volume 27 Number 1 n March 2003 Cancer Forum n Volume 27 Number 1 n March 2003 3 F F Clinical trials: Benefits and challenges We’ve got a groovy thing goin’ baby… or have we? ORUM ORUM Involving women in clinical trials popular in many tumour types but comparative trials severely A Coates AM 2 limited its applicability. An early attempt to justify government S Lockwood • may turn down the opportunity to participate in trials . CEO, The Cancer Council Australia support for the costs of clinical trials as a good investment was But there is another side to this litany of problems. Work done Breast Cancer Action Group International Breast Cancer Study based on this work. Laetrile was an “alternative” medication by the National Breast Cancer Centre surveying women who Fairfield, VIC Group popular in the 1980s, and more recently we have seen the had been recently diagnosed and treated for breast cancer showed that most women were not invited to participate in Australian New Zealand Breast influence of clinical trials in reducing the use of high dose a clinical trial. Only 6% of women were asked to participate, chemotherapy with stem cell support for breast cancer. Cancer Trials Group of these, half said yes. That is, 50% of women with whom a Sydney, NSW trial was discussed agreed to participate. So, while only 3% Challenges of women participated in trials, this was 50% of the women offered the chance to participate. Geography provides problems in multi-centre trials, especially Abstract These figures indicate that the main problem is not with Clinical trials provide the evidence basis for rational decision- if multiple time zones are involved, though modern This paper explores how the number of women in clinical the women refusing to participate in a trial, but that so few making in medical therapeutics. They provide benefits to communication is reducing this aspect of the problem. trials might be increased and the extent to which researchers, women were asked in the first place. This experience is not participating patients, future patients, the community, third clinicians and women are jointly working to improve outcomes unusual, and fits with data from other surveys3,4. party payers (such as governments and private health insurers) Consumers reasonably want access to information about for women. It explores the issues from the perspective of But, where are the real impediments? Why aren’t women and to participating clinical researchers. available trials, but apart from the United States, few women with breast cancer, but the arguments presented here being asked to be part of a clinical trial? countries provide reliable access to such information. Patient are applicable to other diseases. It also considers the loss of trust in the research process that results from inappropriate There are three options: Benefits recruitment is highly variable, but generally low. There are promotion of results. The Women’s Health Initiative trial is used • more relevant trials; many examples to support the claim that this is not due to as an example of how fear and loss of trust can ensue. Some • increased numbers of participants; and Patients participating in clinical trials receive treatment under patients being unwilling to participate, but rather to barriers mechanisms to improve trust are suggested, such as community rigorously defined, ethically scrutinised protocols. There is at the doctor level4. information
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