Health

the big shift is here

For too long, clinical trials have taken place in Australia according to significantly varied standards. This has created a multitude of challenges for the medical system, with various hospitals and testing facilities working on methodologies and standards that are far from uniform, and therefore producing results that are difficult to compare, analyze and implement. Most importantly, the way the system worked ultimately led to poorer patient outcomes.

But there comes a cultural shift. The Australian Commission for Safety and Quality in Healthcare launched the National Clinical Trials Governance Framework at the ARCS (Association of Research and Clinical Scientists) conference in Sydney.

This is an important step in repairing the system and moving towards better patient outcomes, as it sets a minimum standard for clinical trials across all sites conducting clinical trials in Australia. Once adopted, the framework aims to increase the quality and speed of clinical trials on sites, meaning they are likely to be more attractive to large pharmaceutical and CROs driving incoming investment in Australia.

A higher standard and improved patient outcomes

However, the success of this change is not a given, at least not in the short term. Australia has never before had a national governing body to oversee clinical trials, so sites may need to make significant changes.

The most compelling incentive for test sites such as hospitals to meet these new standards is that they may lose their accreditation, but they should also want to make these changes. That said, a uniform framework for clinical trials will not only result in the entire country singing from the same anthem sheet and attracting more investment, but a higher standard of clinical trials will also result in improved patient outcomes for each facility.

So how did we get here? To begin with, each individual research site gives different importance to clinical trials, and each has its own priorities. No single test location will function exactly the same, with exactly the same needs. Access to clinical trials has traditionally been much more about who you know or who your doctor knows, such as where you are. These governance changes apply to a move, particularly in regional Australia, to teletrials and more decentralized trials. Not having people in regional areas can participate in trials means you exclude important sections of the population, often and especially First Nations Australians. The new framework takes an important step towards democratizing access to health care and reversing the idea that power, money and access are the most important factors in whether people can access new therapies through trials.

Although this new management framework is clearly spelled out, it will come down to individual chief medical officers, executive directors of medical services and their research directors to ensure that it is established as best practice. In the past, we have seen clear regulatory frameworks proposed at the organizational level, and although seniors generally have a solid understanding of the proposed framework, in most cases decisions about when and how to implement new guidance are shifted to a junior person who is not powerful and does not want to take any risks. In addition, many CEOs of hospital and clinic do not have research like KPI, so it leads to a culture where management officers are likely to slow down or slow things down to take the most risk-averse approach.

Embedded trials in the health care system

We must ensure that the new framework is adopted and not delayed by internal bureaucracy. We need to continue to highlight the fact that research and clinical trials are improving patient outcomes. Finally, a clinical trial is a structured way to test a new intervention or therapy. Without it, facilities only provide a standard of care and do not improve treatments. It is about embedding clinical trials in the healthcare system. It is not about having clinical trials in one part of the organization and facility, and doctors treating patients in standard clinical care elsewhere. The best results for everyone happen when clinical trials are embedded in the system and are treated as one and the same.

Finally, you would have trouble finding anyone who disagrees that the National Clinical Trials Governance Framework is an important step in the right direction. It represents recognition that the Australian Health and Safety Commission has a greater role to play in effectively regulating clinical trials. This has come about through pressure on several fronts, including significantly increased media coverage of the problems with how clinical trials have been conducted in Australia – and recognition that current governance processes have blocked research from actually happening on sites. More visibility around this has seen the Commission take action, forcing its hand to step in and become more closely involved in the management of clinical trials.

The implementation of this framework will require significant cultural change, and at Chrysalis we help teach people to work in a different way. There is complexity to understanding the new framework, but the biggest challenge is to adopt it. It needs to be approached in a way that is not purely theoretical and have this new framework on a piece of paper. It’s all about changing behaviors and setting up systems that make life easier for clients, researchers, and administrators who are tracked and actually working in the long run.

* Nick Northcott is the founder and Managing Partner of specialist health and medical research consultancy firm Chrysalis, which has grown rapidly across Australia since 2016. Chrysalis provides consulting services including strategy and growth advice, IP commercialization and a specialist clinical offering to the clinical research and management markets.

Nick has extensive experience in advising boards, CEOs and executives to manage complex innovation and change projects, on high-risk issues (e.g., research, disputes and governance issues) and to complete value-added deals, including having more then raised $ 100 million in venture, philanthropic, subsidy and corporate finance.

Top image credit: © stock.adobe.com/au/toytoey

the big shift is here

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