How NSW Health’s can-do approach is creating an ecosystem that allows clinical trials to thrive

Two clinical trials aiming for better outcomes for cardiac patients. Both, too, benefitting from the streamlined ecosystem NSW Health has created to attract cutting-edge international research. Together, they showcase what NSW can offer: physicians, facilities, ethical and legal frameworks and government support. 

But in a COVID-affected world, they might hint at something more: a roadmap through at least some of the logistical nightmares created by a global pandemic. With international travel – for knowledge sharing, for training and oversight – difficult for the foreseeable future, some trials indicate that NSW’s can-do environment could reduce reliance on international travel and provide more flexibility to get research done.

The Extravascular Implantable Cardioverter Defibrillator (EV ICD) pilot trial for example. Sponsored by international medical tech giant Medtronic, is examining a new placement for the defibrillation coil of an ICD, a life-saving device that detects irregularity and delivers therapy to restore normal heart rhythm. Australian physicians involved would normally block out a week in their diaries, cancel patient appointments and cross the globe to the state-of-the-art US training facility to learn about the new device or procedure. A great experience, but costly in hours for the physician and in dollars for the sponsor.

But why not train where the physicians are? EV ICD pilot trial lead and senior clinical research specialist Samuel Liang explains that Sydney met the company’s exacting requirements for a training hub: a convenient central location with well-appointed lab facilities in which to bring scientists, engineers and lab technicians together.

Access to live animal model and human cadaver-model training were essential for the EV ICD trial training, and Sydney has that capacity as well. 

“Having the facilities for training is actually something that can’t be taken for granted,” Liang says. “We’ve looked at facilities in other regions and, in the end, they were not always able to provide both the cadaver and the animal models to allow us to conduct training.

“In this COVID era where travel, especially international travel, is being more and more limited, if there’s a requirement for hands-on training, we need the training to be conducted in the countries where the physicians are based.” 

The existence of quality medical facilities statewide means NSW clinical trial capacity isn’t anchored to the capital city, either. The Medtronic-sponsored Pulsed AF pilot trial at the John Hunter Hospital north of Sydney is a case in point, luring world-first research to Newcastle. Atrial fibrillation (AF) involves rapid heart rhythm in the upper chambers of the heart. Ablation – a procedure that is, traditionally, heat or cold-based – creates scar tissue within the heart to stop abnormal electrical signals and prevent them from spreading and continuing to cause AF.

This Pulsed AF pilot trial is aiming to evaluate the safety and effectiveness of a new technology that uses pulsed electric fields, a non-thermal technology (meaning there is no heat or extreme cold), to ablate and treat AF. It’s exciting, and according to one of the principal investigators, cardiologist and electro-physiologist Dr Bradley Wilsmore, this pilot trial represents “everything we want to do in medicine”.

“There were thousands of sites around the world – literally – that were wanting to do it, and they narrowed it down to four operators in Europe, the US, Canada and Australia and of the top four locations, Newcastle was picked as the preferred site to do the first in the world. It’s fantastic for us,” Wilsmore says.

Key to the trial was identifying a physician with extensive experience in the use of Medtronic catheters. While Wilsmore certainly ticks that box, he stresses: “it’s way more than me.

“It’s about much more than a high volume operator: it’s a high volume team, it’s ethics approval, it’s the healthcare system, it’s the research team to support it, it’s other clinicians being available, it’s research staff, it’s getting access to patients who will be willing to participate”.

While it’s not uncommon for US-based sponsors who want to use their technology internationally to nominate distant trial centres, Wilsmore says they’re rarely the world-first location. But John Hunter Hospital clearly aced Medtronic’s rigorous selection process.

“Newcastle is far from rural, but its small enough that you have some personal contact with staff, and patients who are super keen to get some high-end intervention. And its big enough that you can perform those high-end interventions.”

Both Medtronic-sponsored trials highlight NSW’s can-do approach according to Dr Deama Amr, the company’s Australian Senior Clinical Research Manager. While the advantages are clear to locals, she says the sell to head office hasn’t always been easy. 

“A lot of companies across the industry are very US-centric in their mindset of doing clinical trials because that’s the environment they know, that’s what they’re most comfortable with, they can predict the timelines . It’s easy to go with what you know.

“What we’ve been doing as part of Medtronic here in Australia in the last five years is really pitching what an incredible clinical trial-friendly ecosystem we have, so we can really speed up the clinical trial process.”

Critical to the process are ethics committees. Once physician and location are chosen, the site ethics committee gets to work examining the protocol. Experienced and thorough, their appraisal often improves trial protocols while prioritising patient safety.

Medtronic has benefitted from NSW Health’s services when it comes to negotiating and troubleshooting with multiple facilities. These services can now be accessed online via Clinical Trial Connect and Clinical Trial Triage pages.

“Time and effort have been invested at a state and national level to help bring research to Australia. It’s up to the companies, too, to lobby for that with their global partners and really highlight these benefits because, to be honest, they don’t know about them.”

By Michelle Schlechta

Need support progressing your clinical trial in NSW?

Do you need support progressing your clinical trial in NSW, or have a similar success story to share? Get in touch with clinicaltrialsNSW. The team can help you navigate through the clinical development pathway.