Monday, September 06, 2021

Case Study - PLUS Study and The George Institute for Global Health

When it comes to clinical trials, we look to make a difference around the world with our savvy software platform. We speak to Sharon Micallef, a Senior Project Manager from The George Institute for Global Health, about her experience working with the team at Spiral to produce a database for her latest study.


With 20 years of experience behind her as a nurse and an intensive care research coordinator, Sharon Micallef understands the demands and pressures of working within a hospital environment. Now a senior project manager at The George Institute for Global Health, a leading independent medical research institute, she has spent the last ten years working in the Critical Care Division on academically-based studies, drawing on her previous experience to help run trials that will benefit critically ill patients.    

Based in Sydney, her latest study, PLUS (Plasma-Lyte® Vs Saline) is a multi-centre, blinded, randomised, controlled trial (RCT) which will determine whether fluid resuscitation and intravenous fluid therapy with a “balanced” crystalloid solution (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid resuscitation when compared with the same treatment using 0.9% sodium chloride (saline).

Essentially, the study has been comparing two types of intravenous fluids that are used as standard care in ICUs in Australia and New Zealand. There has been an ongoing discussion about the high chloride content in saline and its potential to cause acute kidney injury, but they wanted to know, is Plasma-Lyte safer? Sharon’s study needed to easily and efficiently compare these two standard fluids for patients that require fluid resuscitation in ICUs.

With over 5,000 patients enrolled across Australia and New Zealand, it was vital to create a study database that was designed in a way that made inputting information on the frontline as easy as possible. Halfway through the initial study database design, Sharon came to the realisation that it was too complicated from a research coordinator’s perspective. 

“If your research coordinators find it hard to work with the database, it impacts on the study, recruitment, speed of entering data - the flow-on effect is huge”

Knowing that the current format would slow down recruitment, Sharon decided that something needed to change - and fast. Having worked with Spiral before on the HEAT study several years ago, Sharon felt that engaging with our team would be the right way to go, even if it meant a setback in the timelines of the study. 

A conversation with the PLUS study Chief Investigator Professor Simon Finfer led to a meeting with our Founder Audrey, and work got underway almost immediately and - as they say - the rest is history. This change in the database meant an 8-month delay in starting recruitment but Sharon believes it was worth the wait. 

“I tell everyone it is worth putting that effort in at the beginning. In the end, we haven’t needed the data validation resources other studies require because it was so beautifully done by Spinnaker - I’m very grateful to Audrey and the team - we have a great working relationship”

The bespoke design process was something new to Sharon and she admits being thrown in the deep end. Sharon provided paper forms to work from (randomisation, baseline etc). Our team were then able to design a similar electronic format. 

“There was a lot of hard work involved but Audrey and the team were extremely patient with me”

With her own personal experience front of mind, Sharon understood the wants and needs of both ICU nurses and research coordinators and was able to translate this to Spiral. It was imperative that the functioning database required very few steps, making the randomisation process as easy as possible for the nursing and medical staff who were physically inputting the information while attending to a critically ill patient. This need underpinned the entire trial. 

“Throughout the process, I would think to myself: what would I want if I was working at the other end? What would make my work easier?”

While the results of Sharon’s study are still embargoed, she could say that working with Spiral and the use of Spinnaker has made the process so much easier. Being able to access reports and blinded data all the way through the study has made things so much more efficient.

To give some background on this, study databases traditionally work with something of a data management ‘middle man’. Meaning that if a report is needed, it has to be requested through data management, taking a few days to return before anyone can review the data and check for inconsistencies. But with the use of Spinnaker, if Sharon needs a report with specific data, she can simply download a blinded report,  filter data, check for inconsistencies and send data queries to sites straight away. Sharon believes the ease with which she is able to access and review everything herself saves so much time. 

“It is undoubtedly one of the best features.”

When looking to the future of trials, Sharon believes that a good database is absolutely essential. Without one, timelines can stretch out endlessly, making the trial seem impossible to complete. Whilst Sharon has mostly worked on randomised controlled trials, she loves the way that Spiral has been able to embrace platform trials where multiple treatments are tested at the one time.

Personally driven by the power of clinical research, Sharon is an advocate for any product that enables researchers to conduct trials more efficiently, which in turn benefits people and patients in the long run. Her inherent need to help people through her study, research and trials is made all that much easier with Spiral. 

“Spiral has been amazing, I have had a great time working with them. They have been very professional and answered all my questions, even the silly ones. I have learnt a lot from Audrey and the team. I would highly recommend them as a company and their product to anyone really. It makes my job a lot easier.”