Clinical trials: the big shift is here

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

But a cultural shift is coming. The Australian Commission on Safety and Quality in Health Care launched the National Clinical Trials Governance Framework at the ARCS (Association of Research and Clinical Scientists) conference in Sydney.

This is an important step towards fixing the system and moving towards better patient outcomes as it imposes a minimum standard on clinical trials across all sites that undertake clinical trials in Australia.

Once adopted, the framework aims to increase quality and speed of clinical trials at sites, meaning they will likely be more attractive to big pharma and CROs driving inbound investment into Australia.

A higher standard and improved patient outcomes

The success of this change is not a given though, at least not in the short term. Australia has never previously had a national governance framework to guide clinical trials, so sites may have to make significant changes.

The most pressing incentive for trial sites like hospitals to meet these new standards is that they could lose their accreditation, but they should also want to make these changes too.

As mentioned, a uniform framework for clinical trials will not only result in the whole country singing from the same hymn 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 start with, each individual research site ascribes importance to clinical trials differently, and each has its own priorities. No singular trial location will function exactly the same, with exactly the same needs.

Access to clinical trials has traditionally been significantly more about who you know or who your doctor knows, as well as where you are located. These governance changes tap into a movement, particularly in regional Australia, towards teletrials and more decentralised trials.

Not having people in regional areas be able to take part in trials means you exclude significant parts of the population, often and particularly First Nations Australians.

The new framework takes an important step towards democratising 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 via trials.

While this new governance framework is clearly spelt out, it will come down to individual chief medical officers, executive directors of medical services and their research directors to ensure it is put in place as best practice.

In the past we’ve seen clear regulatory frameworks proposed at an organisation level, and while senior executives have generally had a solid understanding of the proposed framework, in most cases decisions about when and how to implement new guidance gets pushed to a junior person who is not empowered and doesn’t want to take risks. In addition, a lot of hospital and clinic CEOs don’t have research as a KPI, so it leads to a culture where governance officers are likely to delay or slow things down to take the most risk-averse approach.

Embedding trials into the healthcare system

We must ensure that the new framework is adopted and isn’t slowed down through internal bureaucracy. We must continue to highlight the fact that research and clinical trials improve patient outcomes. In the end, a clinical trial is a structured way of testing a new intervention or therapy.

Without it, facilities are delivering only a standard of care and treatments don’t improve. It’s about embedding clinical trials into the healthcare system.

It’s not about having clinical trials in one part of the organisation and facility, and doctors treating patients in standard clinical care somewhere else. The best outcomes for everyone happen when clinical trials are embedded into the system and are treated as one and the same.

Ultimately, you’d struggle to find anyone who disagrees that the National Clinical Trials Governance Framework is an important step in the right direction. It represents recognition that the Australian Commission on Safety and Quality in Health Care has a bigger role to play in effectively regulating clinical trials.

This has come about due to pressure on several fronts, including significantly increased media coverage about the problems with how clinical trials have been run in Australia — and recognition that the current governance processes have been blocking research from actually happening at sites. More visibility around this has seen the Commission act, forcing its hand to step in and get more closely involved with clinical trial governance.

The implementation of this framework will require significant cultural change, and at Chrysalis we are helping people learn to work in a different way.

There is complexity around understanding the new framework, but the biggest challenge is around adoption. It must be approached in a way that isn’t purely theoretical and having this new framework on a piece of paper.

It’s all about changing behaviour and putting in place systems that make life easier for clinicians, researchers and administrators that are followed and actually work in the long term.

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

Nick has extensive experience advising boards, CEOs and executives to manage complex innovation and change projects, on high-risk matters (eg, investigations, disputes and governance issues) and to complete value-adding deals, including having raised over $100 million in venture, philanthropic, grant and corporate funding.

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