International Clinical Trials Day: Q and A with TRI’s Steve Turner

On International Clinical Trials Day on 20 May, we honour the incredibly hardworking professionals in the clinical trials sector at TRI and globally, who  are  improving the quality of life of many patients. 

We chatted with Steve Turner, TRI’s Clinical Trial Development and Operations Manager, about his background and passion for great collaborative research. 
 

• Where did your journey into clinical trials begin? 

I’ve had a very interesting career progression. When I first started out, I had the option of breaking out into a more clinical pathology career or into medical research. As it turned out, I went down the medical research road. I had completed  my Honours and Masters Degree and worked with a number of groups down at St George Hospital and then at Neuroscience Research Australia, helping to head a facility there, which was a national NHMRC funded enabling facility - Genetic Repositories Australia (GRA), a biobank resource of DNA and cell lines. The opportunity then presented itself to move from Sydney to Brisbane to work with a large group over at QIMR Berghofer who were funded through the [Bill and Melinda] Gates Foundation testing anti-malarial drug candidates and vaccines. That was where I was first introduced to clinical trials.

At QIMR, the clinical research I was associated with were ‘healthy volunteer’ studies. In Healthy Volunteers, I worked with malaria and we’d actually inject the healthy person with an inoculum containing malaria parasites first, which sounds crazy I know, and then we’d give them the drug to see how effective it was at treating (or preventing) the disease. They were often trials that were first in human testing and administering drugs within humans.  I was associated with that for the best part of more than five years and enjoyed my time there.

I started at TRI just over two years ago, when the COVID-19 pandemic began and initially met all of my team virtually. At TRI, we are very patient-based, and we work with the Princess Alexandra Hospital and the Queensland Children’s Hospital, the clinicians, departments and supporting vendors (pharmacy, radiology, and pathology). We work with clinicians and patients with a particular disease indication that we conduct clinical trials for here. Most of the clinical trials we work with within industry are commercially sponsored (involve pharmaceutical companies), and often they’ll approach a clinician or our team if they’re interested to conduct a clinical trial. These are drugs, depending on the phase of the clinical trial, which aren’t available to the market for routine standard treatment of the disease or condition, as they’re still in a ‘testing stage’ for safety and efficacy.

• What key research has been accelerated thanks to the TRI-based researchers? 

The lifecycle of a clinical trial or of a drug - from initial discovery, preclinical development, through to early phase testing, to when it’s actually completed all phases of clinical trials, to eventually when it’s actually approved and available to the market can take on average at least 10 years , depending on the drug. So, for some of our trials that we’ve done here, we’re working with pharmaceutical companies where we’ve been the first site in Australia to dose the first patient.  

That’s pretty exciting where you think you’re right at that forefront of working with a pharmaceutical company to dose a patient for the very first time. And it’s exciting to see and follow that journey. The first patient, dosed at Princess Alexandra Hospital in Brisbane, Queensland, was treated as part of the ProstACT SELECT clinical trial, a Phase I radiogenomics study.

Our work and support here at TRI is quite diverse. We have a number of clinical trials underway, in ophthalmology, medical oncology, haematology, respiratory, hepatology, gastroenterology, and orthopedics. We have supported studies that have been run over at TRIC, which is TRI’s pediatric facility over at the children’s hospital there in South Brisbane.

• Where do you hope to see breakthroughs?

Making progress in treating every disease is important. Obviously there are a lot of clinical trials conducted in the cancer space and many patients often seen in cancer trials. For me, it’s not so much one particular disease indication that I would just love to see changed but it’d be great if all of them could be improved. For me, it’s more about what benefit comes to the patient as a result of what we do. If that means that if patients in 5 years can retain some benefit as a result of a clinical trial that we provided support for now, like extending their survival rate or improve their quality of life, then I see that as an accomplishment or a significant breakthrough because we played a small part in a very big picture in contributing to it. And that’s the thing with clinical research, there’s many, many players and stakeholders and it’s a lot of time involved.

• The Translational Trials team provides a great service; explain why our facility is so unique and innovative? 

When I first joined the Translational Trials team, what appealed to me the most was that I think it was clear here at TRI that there were huge opportunities to work with Metro South Health and Children’s Health Queensland clinicians and our partners to increase the capacity to undertake clinical research and they had a patient population that could benefit from getting access to clinical trials.

So, when I first started here, probably one of the areas that the Translational Trials team really complements is that those clinicians may not have the infrastructure or access to the resources needed to run a clinical trial. Now those resources could be staffing or facilities. The resources could be skilled people with the knowledge and the experience required to work with the clinician in the startup phase who understands ethics and governance, the regulatory environment, good clinical practice and quality processes. We basically work with the principal investigator throughout the entire life cycle of the study, from startup right through to close out.

There are huge opportunities for clinical research here at the PA Hospital and for our team and TRI. We offer the excellent Clinical Research Facility, and I’ve never seen a specialised set up like that. It’s brilliant for patients and has a pleasant environment outside a busy hospital clinic. The nurses and care that the patients receive is exceptional. I think we’ve got a huge ability and capacity here, not just in Brisbane and Queensland but within Australia and globally, to work with clinicians and provide them with access to dedicated, specialised teams of professionals and to offer a facility that really does benefit patients.

• What have we learnt about clinical trials in a global health pandemic?

That things change very quickly. With COVID-19 and running clinical trials globally, I think many organisations needed to adapt very, very quickly.

Patients were potentially infectious with something that was new, which according to a lot of clinical trial protocols may not have already been considered, because when they run a clinical trial they’re quite specific in their inclusion/exclusion criteria that makes a patient eligible (or not) to participate in a clinical trial. And so, from an administration and a clinical perspective, it would just throw a massive spanner in the works as to how we can continue to run a clinical trial, how can patients who do have COVID still attend visits, and if they can’t attend visits, what impact does that have on them completing the trial and getting the data that’s needed to complete the study?

Australia, in my opinion, was a bit behind the true and full impact of when COVID hit, so, obviously, the impact of COVID overseas meant that there were many countries and trials that patients could not participate in clinical trials. So, a lot of trials were shut down, clinical and administrative staff couldn’t work, patients couldn’t travel, everything is affected.

Pharmaceutical companies may often have many, many sites running the same clinical trial and they do that for specific reasons and so when those sites overseas started to close, there was a significant push within Australia to open new sites to increase patient recruitment. We then experienced quite a lot of unprecedented demand for opening new studies due to what was happening overseas because Australia was still in that fairly early stage of the pandemic. So, we needed to adapt and think outside the box and work very closely with our research governance office, ethics committee, study team, trial sponsors and clinicians and patients to try to oversee what could be done with minimal impact. So, it’s a very collaborative effort, everyone worked really well together.

• Is the way clinical trials are being done being reinvented or how are they adapting in this evolving, chaotic world?

Clinical trials are conducted according to the protocol and site standard processes. Something very, very simple like obtaining a written signature on a document to provide approval during a global pandemic and lockdowns was new.

Through COVID, lockdowns and pandemic, people needed to think outside of the box. Meetings that used to be onsite were switched to virtual, signatures that used to be written switched to electronic. Some places may or may not have had processes in place to deal with that. Ethics committees that routinely met face to face, switched to meeting remotely, to provide approvals.

The study design of some clinical trials meant that some essential visits could only be conducted onsite whereas for other studies the study team were required to work with the sponsor to see which study visits could be done remotely via telehealth or a follow-up phone call, rather than having a patient come in.

So again, I use the word adapt because COVID wasn’t going away any time quickly and so we still needed to progress and move forward. I think moving forward with clinical trials, and the way that the governance and the approvals and how people communicate - even through to how patients are recruited and the platforms of how the data is obtained - has led to a lot of advancements in that space. There has, in my opinion, been a big shift from traditional to what the future may look like.

• How do you think TRI is positioned in terms of advancing clinical trials and the research of critical health issues? 

I think we are at the forefront of supporting clinical research. We have a fantastic building here that is an excellent collaboration between Metro South Health, TRI and all of the partners. From my few years of being associated at TRI and the Translational Trials team, and through my conversations with the clinicians, there is this desire to want to increase capacity to undertake clinical research. So, in the future, we want to be working with researchers here to conduct early phase Healthy Volunteer studies at TRI, and with the clinicians over at the PA to continue to support them in the patient-based trials across phase 1 to phase 4.

TRI is very supportive across all levels of the organisation and its partners are also, noting the significant amount of research which is undertaken here in this building. We have excellent facilities, like our Core facilities, and excellent research happening at the laboratory bench. We also have the opportunity to work with startups and industries like Vaxxas and so forth, and those clients, and now a dedicated medical manufacturing facility being explored.

I think when you look at the excellent infrastructure that TRI has through the clinical research facility and TRIC over at the Children’s Hospital and the excellent administrative support available to researchers and clinicians provided through the Translational Trials team, I believe we’re placed in a very unique opportunity to be able to offer that full turnkey solution. I certainly haven’t come across such a collaborative, dedicated and committed organisation in supporting clinical research. It’s really amazing to be part of that.

I would like to make a special mention and show my sincere appreciation and thanks to my fellow team members, Dr Helen Benham, Kay Hawley, Hannah Fane, Jodie Robinson, Paul Morgan, Ty Humphries and Clarissa Nicholls acknowledging their tremendous effort, hard work, dedication, commitment and support that without them we would not be able to provide the support capabilities and do the important work that we do.