The purpose of the Australian and New Zealand Fontan Registry is to report the outcomes of current medical practice and to develop research and other strategies to improve quality of life for individuals with a Fontan circulation and their families.
We believe that real progress in our field can only be achieved through the involvement of families, the medical profession, Industry (manufacturers of medical devices, pharmaceutical companies and other for-profit organisations), and not-for-profit organisations, such as HeartKids (Australia) and Heart Kids NZ.
When the Registry began, our focus was on publications for medical journals and harmonisation of treatment strategies across Australia and New Zealand. Partly as a consequence of the success of this early work, industry partners are interested in working with the Registry.
The Steering Committee of the Registry seeks to clarify the relationship between the Registry and industry, to disclose current financial support and highlight opportunities arising from this relationship.
Relationship with Industry – The Registry is independent from, and separate to Industry partners. Many of the Steering Committee and physicians in Australia and New Zealand are engaged as medical experts providing advice to Industry in relation to scientific direction and proposed study design. In some situations, this involves payment of an honorarium and where this has occurred, it will be disclosed in any Registry presentation and publication. In other cases, the Registry receives financial support from industry partners as a recognition of the Registry’s work. These funds may be used to support salary for Registry staff, other Registry infrastructure needs and educational activities.
Opportunities in working with Industry – It is important that Australia and New Zealand are identified as good places to evaluate new therapies, particularly new medications that might improve quality of life and minimise long term medical problems. This will provide early access for ANZ patients to potentially beneficial treatments sometimes decades before they are available worldwide.
Responsibility of the Registry in advocating for Industry trials - The Registry would not allow use of Registry data or advocate for any trial or device that the Registry Steering Committee does not consider appropriate or potentially beneficial for Fontan patients or their families. The Registry may recommend consideration of participation in trials of medication or devices, understanding that the responsibility for providing medical advice and disclosure of risks rests with the participant’s trial doctor (i.e., the clinician-researcher involved with the trial at the hospital).
It is important to understand that while Pharmaceutical companies may provide some financial support for the Registry, and some Registry staff in individual centres may also be employed by the Pharmaceutical Company to facilitate the enrolment of individual patients, the Registry is independent from these Industry bodies. No identified information will ever be provided to Industry partners.