Identifying Effective Treatments Together.

As clinical trials in the world grow and develop, so too do the opportunities for Spiral to make a difference with our savvy platform software. 

We spoke to Professor Steven Tong about the SNAP Trial, his experience working with the team at Spiral, and the application and impact of our Spinnaker software in his study.

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Professor Tong is an infectious diseases physician with the Victorian Infectious Diseases Service. He spent 10 years in Darwin before moving to Melbourne to join the Doherty Institute; a joint venture between The Royal Melbourne Hospital and the University of Melbourne. With a passion for applying cutting-edge science to address clinically driven questions, he is now heading up the SNAP Trial team with fellow coordinating investigator, Professor Joshua Davis. 

The SNAP (Staphylococcus Aureus Network Adaptive Platform) Trial is an adaptive platform clinical trial that aims to improve treatments for those with bloodstream infections of Staphylococcus Aureus or Golden Staph. It is a disease frequently seen by infectious diseases doctors and is one of the most common causes of bloodstream infections in the world. The SNAP study looks at several different treatment strategies for these infections with the aim of improving outcomes for those affected by them.

‘This trial is a first of its kind in that it is recruiting adults and children.’

The trial itself is still in its infancy. Having only started in 2022, there are currently 202 patients enrolled from Australia, New Zealand, and Canada. However, Professor Tong and his team are aiming for 7000 enrolments over the next four or five years, with the expansion into other countries.

‘We will be recruiting patients as long as it remains a public health problem and as long as there are questions for us to try and address - we’d like to keep rolling patients in.’ 

Software that provides flexibility and logic.

Professor Tong describes the trial as incredibly complex. It includes multiple domains and multiple subsets of staphylococci based on their antibiotic resistance profiles. With numerous sites across the globe taking part each with differing regulatory processes, there are constant obstacles to overcome. This is why it was essential to build logic into the trial database with Spiral and Spinnaker.

‘Spiral’s software allows a lot of flexibility. In the trial, there are multiple time points where different things need to happen. However, Spinnaker is able to handle the complexity of the multiple logic steps that are involved.’

Adaptive Platform Trials (APTs) aim to answer multiple questions in a disease area through an established infrastructure and the use of a master protocol. As the trial progresses, APTs are designed to analyse accumulating data at specific intervals as patients are enrolled. 

Because there are five or six questions being asked in the SNAP trial in parallel, such as whether or not oral antibiotics at an earlier stage are effective, the trial needed to be tailored for each individual patient. Patients are able to enter as many domains as they want and Spinnaker as a platform is able to judge each patient and their eligibility and allow for individualised treatment strategies. 

‘This was one of the main ways in which Spiral allowed us to determine the best treatment strategies for the patients. We are able to adapt to their individual needs’

A collaborative relationship.

Josh Davis, the co-primary investigator on SNAP had worked with Spiral on a previous study, Camera 2. Through Camera 2 they had formed what Professor Tong describes as ‘a great relationship with Spiral’, acknowledging that the front end of the database was easy to use for sites. 

‘We want to make it as easy as possible for sites. To be able to collect data with ease is a huge advantage and a very attractive feature of Spiral’s software’. 

They felt that they worked well with Audrey and the team, therefore it was a logical choice to engage with them again for SNAP. 

‘Not many vendors have the capabilities that Spiral does. We have specifically chosen their software with the understanding that the trial is quite complex and therefore requires dedicated time with Spiral to design it.’

Designing bespoke software for trials isn’t without its challenges, however. Professor Tong acknowledges that adaptive platform trials are relatively new within the industry and that almost any APT requires complex bespoke database design. It is a carefully considered process that requires collaboration between all parties involved. 

‘Audrey and the team have always been open to feedback - there are important discussions to be had. Communication with the team is good, we feel like there is respect and trust between both parties.’

Driven by a desire to improve on a global scale.  

This particular trial has been particularly important to Professor Tong. As a physician, he sees these infections almost weekly on ward service at the hospital. In an under-researched area with a mortality rate of 20%, it was only natural for questions to arise as to how this condition could be improved for people and what other treatment options have not yet been explored. These unanswered questions drive Professor Tong to improve the management of this common and potentially deadly infection across the globe. 

‘One of the key things in trials is setting up the infrastructure to be able to randomise patients and collect data in a robust manner so that you can be really confident of the quality of that data - Spinnaker and Spiral provide that for investigators.’ 

While there are no results from the trial as of yet, Professor Tong and the SNAP Trial team, with the help of Spiral, are focused on continuing a robust clinical trial that aims to answer the questions raised and benefit those affected by the infection. 

Looking to the future, Professor Tong sees clinical trials continue to be essential in the advancement of disease treatment. Research within a laboratory certainly has its place but good clinical trials with patients are needed in order to produce real-life results. Adaptive Platform Trials are undeniably crucial for the advancement of medical treatments and with Spiral providing the infrastructure and ability to efficiently collect data, the potential to improve lives across the world is boundless.

‘If we can find ways to improve our practice as physicians within a clinical trial then we can improve treatments for patients all around the world’