Key points are not available for this paper at this time.
Multi-institutional research gives a more representative appraisal of surgical practice and enables statistical power to answer relevant questions in randomized controlled trials and other research methodologies. In Australia, breast cancer is the most common non-skin malignancy and significant multi-institutional research is consistently being undertaken, predominantly under the auspices of the collaborative clinical trials group Breast Cancer Trials (BCT). A major project underwritten by the BCT Clinical Research Fellowship was to develop the Australian and New Zealand (ANZ) Targeted Axillary Dissection (TAD) Registry. TAD is the localisation and removal of previously metastatic axillary lymph nodes usually marked at diagnosis with a radiologically visible marker clip, as well as the removal of identified sentinel nodes, after neoadjuvant systemic therapy. The aim of the TAD Registry was to create a de-identified record of all TAD procedures across ANZ, to facilitate an understanding of how as a relatively new and nuanced technique, TAD is being implemented and interpreted. This was conceptualized with the BreastSurgANZ leadership team as a priority area for research and BreastSurgANZ has been strongly supportive in its development and implementation. However, what the investigators considered to be a low-risk, easy to facilitate short-term registry, has taken over 12 months of significant effort, and have still fallen short at this current time. The registry was planned to be running across multiple BreastSurgANZ-affiliated ANZ institutions from the fifth of February 2024. Unfortunately at this date, half of the individual site approvals were still progressing. Plans to roll the 12 month pilot registry into an ongoing audit seem extremely improbable because of the challenges. This article aims to draw attention to the difficulties in establishing a simple multi-centre de-identified finite duration registry. By flagging a few key issues, the hope is that this could prompt discussions that leads to significant improvement and efficiencies in the way we share de-identified data between institutions and states. By achieving that, we could easily improve Australia's international research representation and improve patient care. When applying for Australian ethical approval in multi-centre research, an excellent development is the National Mutual Acceptance (NMA) scheme.1 This scheme, for multi-centre ethical and scientific research, enables a single ethics application that once approved, is applicable for other Australian state and territory-certified public health organizations. After Ethical approval, for investigators to open their study at their institution, they require local research governance, administered by the process of site specific assessment (SSA) which signs off local willingness, resources and capabilities to participate.2 When applying for individual SSA, there are a multitude of different online systems to use. For NSW/ACT/SA there is REGIS (Research Ethics and Governance Information System), for VIC/QLD ERM (Ethical Review Manager), and for WA RGS (Research Governance System). These three systems are not remotely similar in design or structure. Though all have their own associated documentation 'to help guide an application' the extent of time required to learn and use these systems is significant. These guides are excellent for those that understand the individual system from within, but for a novice, these guides are murky at best. Significant time was lost following these guides, submitting applications, only to be informed of rejection. Upon calling individual sites directly, there were cases when it was explained that the guide was not relevant for this particular situation, or out-dated, and a new application needed to be submitted. In some situations, this has required repeated requests for electronic signatures from Surgical Principal Investigators, Hospital Administrators and even Hospital CEOs. All of which, understandably and unfortunately, adds greater delays. A particular issue that this experience flagged, was the significant limitations associated with sharing of de-identified data. While 'data is king', in Australia we are grossly limited with our access to it. It takes an extensive amount of time to coordinate and arrange Data Research Agreements (DRA) or Collaborative Research Agreements between hospitals. The concept that de-identified data collected for a specific research project (essentially the same type of data collected for the BreastSurgANZ Quality Audit (BQA), or the Surgical Morbidity Audit and Logbook Tool) is privileged and requires these DRA between sites and a central co-ordination centre, is illogical and counterproductive. Obtaining approval to allow the entering of de-identified patient data into a registry to facilitate further research to improve patient care, appears on the surface, simple. However, the significant road-blocks in the usage of appropriate templates and ensuring appropriate legal jargon has significantly strained the tenuous survival of this registry. Each state (and in some cases, institutions) prefer their own independent agreement, which can require in-house legal to evaluate the document. All of this for data that is de-identified, is largely being collected already for other reasons, for example, all the surgeons individually or as institutions already put most of it in the BQA, and the sharing doesn't impact patient management or outcome in any way. A significant overwhelming delay was the fastidious mannerism for paperwork. It is incredibly frustrating when multiple sites all have similar paperwork that is just slightly different, with terminology that requires multiple communications with specific governance to understand what exactly is being asked. If the ethical paperwork has been approved by the NMA, why does an applicant then need to provide the exact same data, for individual SSA in their documentation? The amount of repetition in documentation has been astounding. All of which adds significant (unnecessary) delays. In one site, despite completing all the documentation precisely, it took over 2 months for a Patient Consent Form to be approved, due to logo placement. Most patients want to be treated by the current best-practice; practices that have been developed based on evidence from clinical trials. We have a wealth of information potentially available, so why is Australia so far behind in establishing data registries, compared to other developed areas in the world? The American National Cancer Database (NCDB) and Surveillance, Epidemiology, and End-Results (SEER) databases produce volumes of research and publications, consistently improving the international management of breast cancer. The ability for non-affiliated international institutional users to apply for access to the SEER data, has resulted in even greater data utilization. Why do we need to have different SSA models per state, and in some cases, per institution, especially for low-risk studies? Why do we not have a centralized platform that enables progression of studies such as low-risk, low-cost registries that investigators at academic hospitals can apply to be involved in? National privacy, data protection and ethical principles could be monitored in giving that central approval. These issues when associated with Clinical Quality Registries (CQR) in Australia have been previously identified.3 Thankfully, the Australian Commission on Safety and Quality in Health Care are focused on improving them. The recently developed Framework for Australian CQR Second Edition is working towards national arrangements (with guidance on governance).4 The National CQR and Virtual Strategy (a 10-year plan from 2020 to 2030) has a number of actions aimed to address CQR shortcomings. Finally, the National One Stop Shop, is a proposed central platform to 'integrate key approval processes and existing national systems for trials and research to reduce administration and navigation burden for investigators, sponsors, sites and administrators'. This would streamline and improve application and approval processes, as well as management, monitoring, and reporting across the full project life cycle. However consultations to develop the One Stop Shop closed in 2022, with no current trajectory of if, or when, it will become available. Multi-centre research projects hold great promise for advancing scientific understanding and addressing complex research questions. However, the path to success is often riddled with obstacles that can significantly deflate the most enthusiastic researcher. By developing an Australian centralized ethics and governance committee for low-risk registries, we could significantly enhance our available research output. This would result in greater powered studies, increase Australian-researcher engagement and output, and thus improve patient outcomes not only in Breast Cancer, but in all surgical streams. We thank Mr. Heath Badger for his input in the finalization of the article. Dr. Adam Ofri is a recipient of the Breast Cancer Trials Clinical Research Fellowship stipend. Prof. A Spillane is an Editorial Board member of Health Science Reports and a co-author of this article. To minimize bias, they were excluded from all editorial decision-making related to the acceptance of this article for publication. Adam Ofri: Conceptualization; data curation; formal analysis; funding acquisition; investigation; methodology; project administration; resources; software; supervision; validation; visualization; writing – original draft; writing – review and editing. Andrew J. Spillane: Conceptualization; data curation; formal analysis; funding acquisition; investigation; methodology; project administration; resources; software; supervision; validation; visualization; writing – original draft; writing – review and editing.
Ofri et al. (Fri,) studied this question.