Clinical trials of Cancer Therapy in private medical practice in Australia

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Participation in clinical trials of new and evolving cancer therapies is an accepted part of the provision of quality cancer care. They form the basis of logical clinical progress and provide the signs of benefit, the warnings of side effects and the proof of utility required to establish the role of new therapies into funded clinical practice. They provide a measure of the quality of practice and are the basis for professional advice to government for the funding of new therapies under the Pharmaceutical Benefits Scheme. Provision of clinical trials at Phase 2 and Phase 3 levels provides early access for patients to new and promising therapies in a controlled and safe environment where the benefits and side effects can be closely monitored and documented. They provide protection for patients against the provision of treatments outside the limits of reasonable practice. Clinical trials are therefore an essential component of any integrated cancer service, public or private, in Australia.

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Participation in relevant clinical trials is generally taken as a sign of quality medical practice. It provides a template for documentation and self-reflection around treatment approaches and encourages clinicians to review their own practices. It is highly rated by the professional colleges when assessing continuous medical improvement programs. On that basis, cancer services in the private sector have increasingly committed to clinical trial participation. Our own clinical group commenced clinical trial participation in 1989, facilitated by the creation of a not-for-profit entity, The Wesley Clinic Research Centre, which became an active participant particularly in trials overseen by the forerunner of today’s Australasian Leukaemia and Lymphoma Group. It has subsequently changed through the Haematology and Oncology Clinics of Australasia (HOCA) Research Centre into today’s Icon Cancer Foundation which oversees clinical trials in Icon Cancer Care’s five day oncology centres in Queensland. Three of those centres exist in the context of comprehensive cancer care services within private teaching hospitals, and two centres exist within comprehensive day care services. The breadth of care offered by these services allows an extensive clinical trial portfolio which forms the backbone of the work of the Foundation.
The formation of The Private Cancer Physicians of Australia Group in 2006 provided the opportunity to work with other clinical groups around the country to promote clinical trial participation. Now most clinical groups practising in the private sector are involved in some form of clinical trial participation with models varying between institutional not-for-profit foundations as I have described, through for-profit clinical entities or smaller discrete programs attached to clinical practices. While the nature of the funding determines to some extent the trial profile of each group, the basic vision is shared amongst all participants to improve access to new medical therapy and to ensure that the quality of oncology practice. Icon Cancer Foundation has been a very significant contributor to trials proving the efficacy of anti-HER2 therapy in breast cancer, the development of new lymphoma and myeloma therapies and the introduction of innovative immunological therapies in diseases such as melanoma. Our fund raising efforts and the efforts of collaborating small disease-specific foundations has allowed support of and involvement in clinical trials of rare diseases such as sarcoma in adolescents and young adults.
There are important challenges in clinical trial participation across all sectors. Those challenges are drawn into sharper focus in a private practice setting where funding is often initiated by individual clinicians and the supporters of individual clinics. The increasing levels of process that are well documented in clinical trials throughout the western world have led to increasing costs and diminishing margins. These changes are challenging to small foundations. A recent review at The American Society of Clinical Oncology in June 2015 highlighted the increasing challenges in terms of time and cost to physicians and clinical trial coordinators of trials in cancer therapy. While many of these costs reflect the compliance cost imposed by regulatory authorities, individual management styles across different organisations can lead to unnecessary delays in the implementation of new protocols and a loss of investigator enthusiasm. In some major recent clinical trials, simple protocol amendments have had a documented cost of over US$500,000 that have taken a mean of more than 60 days to implement.
Of particular concern across the western world has been a lack of commitment on the part of health insurers to the importance of clinical trial participation. There have been examples in the United States and Australia of health funds failing to provide the costs of the usual patient care component of patients who are on clinical trials. It is critical that health insurers understand the importance of clinical trial participation and agree to the usual costs of clinical care for patients who are receiving innovative therapies in a trial environment. The United States ‘Affordable Care Act’ now mandates health insurance companies cover routine costs associated with approved clinical trials. This innovation is justifiably regarded as an important advance towards universal access of high quality cancer care in the United States. Such legislation is urgently required in Australia to clarify the specific responsibilities of health care payers and clinical trial groups.
Participation in clinical trials in the private sector has been an exciting development over the last 20 years. There will always be challenges but the successes have defined the standard of care across the country and guided Federal Government funding in many clinical settings. Equally, we have been involved in many investigator initiated trials that have led to similar advances in less common diseases such as chronic myeloid leukaemia, rarer lymphomas, germ cell tumours and adolescent and young adult sarcomas. These trials are often the result of collaboration between individual practices, national clinical trials groups, hospital research foundations and consumer led patient support foundations. The private sector has an important part to play in these collaborations, and Icon Cancer Foundation has been successful at building those collaborations for the benefit of patient care. I believe this participation is an essential component of 21st century cancer care. Only with buy-in from clinicians, hospitals, health insurers, government and patients can we ensure that the innovative but expensive new therapies can be introduced in a way that justifies their cost, both to our patients and to the community.
For more information visit www.iconcancercare.com.au
Article written by Dr John Bashford FRACP FRCPA : Board Chair, Icon Cancer Foundation. Wesley Medical Centre, Brisbane, Queensland.