“As someone who was focused on clinical research, it was extremely valuable to see how research is used to develop technology that can be scaled up to address key health concerns,” says Cyril Saji, a third-year medical student at James Cook University, who has just completed his internship with Genovate. Genovate is The George Institute’s innovation and entrepreneurship program.

The Genovate internship program was started in 2020 to provide a launchpad to early career researchers and those interested in health innovation by providing hands-on project experience to solve real world problems. Cyril is the program’s seventh intern to date to have completed a 3-month placement with Genovate. Like his peers, he believes the program filled a gap that many medical students face in the industry.

“As a medical student, it is rare to find opportunities to look at healthcare beyond the clinical context – this internship gave me the chance to develop my knowledge of health innovation, technology and commercialisation and truly encouraged innovative thought and critical analysis - skills which are imperative to being an effective clinician,” he says.

The Genovate internship gives the candidate an opportunity to work on a project spanning the wide ambit of The George Institute’s portfolio. This can range from the Women’s Health Program to Injury Prevention. Collaborating with a cross-functional team provides the interns with an opportunity to develop diverse skills sets and subject knowledge.

Cyril worked within the Institute’s Global Brain Health Initiative where he co-developed a scoping review on 'New Technology Needs in Brain Health', focusing on technology to support post-stroke rehabilitation.

“This project was a wonderful opportunity to understand the scientific, regulatory and commercial aspects of technology development and investment,” he says.

James Bradley, who has just started the Genovate internship, is also working on a project within the Global Brain Health Initiative. James is a fifth-year student at the University of New South Wales, undertaking a Bachelor of Engineering (Hons) and Science double degree. His passion is applying machine learning to solve medical problems.

He says, “I'm currently working on the Deep Learning and Brain Imaging Project, where we are trying to develop a system to automatically segment haemorrhages in the brain from a CT scan. Usually, this is done manually by a radiologist or neurologist by directly outlining bleeds in a scan. Being able to detect haemorrhages quickly and measure their volume accurately is crucial in stroke patient management and clinical trials. Therefore, the ability to automate this process can have a significant impact on patient outcomes.”

The George Institute’s recently established Global Brain Health Initiative, under which both Cyril and James have worked, aims to tackle the serious issue of brain health and enable people to live better for longer. The progressive ageing of the world’s population is associated with a steady increase in age-related diseases including dementia, Alzheimer’s disease and other neurodegenerative disorders. The Global Brain Health Initiative is focused on developing innovative solutions to address these challenges, maintain healthy brain function throughout life and help improve the health of millions of people around the world. The Genovate program supports this mission.

As Cyril says, “Though health innovation is often pioneered and most accessible to the most privileged in society, it plays a vital role in supporting the delivery of care for socio-economically disadvantaged and low-resource communities and can be pivotal in addressing health crises in the future.”

James adds, “I believe that the whole point of technology is to make the world a better place - this is a philosophy which The George Institute demonstrates on a day-to-day basis, making us a good match. Hence, being able to synergise my natural curiosity in this kind of technology with the ability to improve health care, made joining the Global Brain Health Initiative a no-brainer!”

“I would definitely recommend the internship to others who want to use technology for a larger cause – to potentially improve the health of millions of people around the world.”

Find out more about the Genovate program and internship here.

To mark International Clinical Trials Day, we asked Laurent Billot, Director of Biostatistics and Data Science at The George Institute for Global Health, and internationally recognised clinical triallist, about his current work and his thoughts about the future of clinical trials.

“We use clinical trials to build evidence. Evidence that aims to inform clinical practice worldwide and, ultimately, improve health outcomes for individuals and communities globally.”

The George Institute works with partners to conceptualise, develop, and deliver innovative and impactful clinical trials, which Laurent notes are characterised by the following features.

Reducing trial ‘waste’

“Ensuring that clinical trials are efficient is crucial to limiting research ‘waste’,” he said. “This most commonly comes from the costs associated with poorly conceived research questions, inappropriate study design, failure to adequately report on all areas being analysed, and inefficient operational conduct.”

He outlined two key ways that trial efficiency can be improved - by design and through conduct.

“Trial design involves the development and application of innovative statistical methods including adaptive and pragmatic designs. The first involves adapting some elements of the design as the trial progresses (rather than waiting for the trial to end). A pragmatic trial evaluates a health intervention in a setting as close as possible to real-world conditions.”

He cited INTERACT3 as an example of an innovative pragmatic trial to explore the effectiveness of a care package that includes intensive blood pressure lowering in adults with acute brain haemorrhage.

“Adaptive designs help to generate new evidence in a shorter timeframe and better allow the trial to answer questions that may come up at the time,” he said.

Laurent is currently collaborating with colleagues at Imperial College London’s Clinical Trials Unit to review current practice and consider the potential impact of different adaptive designs in critical care trials. This includes a systematic review of recently completed critical care trials as well as simulations to identify the most efficient adaptive designs.

With regards to trial conduct, he notes there is a mismatch between the use of clinical trials as a means of providing evidence-based answers to clinical challenges, and the way clinical trials themselves are conducted, which is not always evidence-based.

“To try and address this, I’m jointly leading a new program based on the concept of Studies Within A Trial, or SWATs. This involves embedding a trial comparing different trial conduct methods – for example face-to-face versus remote visits - within an existent ‘host’ trial, with the aim of evaluating alternative ways of delivering or organising a particular trial process,” he said.

The George Institute is also one of a number of centres in the Trial Forge initiative, which aims to look across all trial processes with the intention of trying to improve them, even if only by a small amount, in recognition of the fact that these gains add up when done across the whole trial system.

The global environmental crisis also requires consideration of how clinical trials are impacting planetary health.

“The George Institute recognises that as health professionals we have a responsibility to minimise environmental harm in order to protect health."

"Clinical trials are a significant contributor to greenhouse gas emissions and pollution. We are exploring ways in which clinical trials might be ‘decarbonised’ - for example, by reducing energy use, streamlining patient recruitment and data collection and minimising travel,” he said.  

“This is likely to be a key area of focus for future trial design.”

Improving relevance and transparency

The COVID-19 pandemic has underscored the role of clinical trials in providing rapid answers to how best to detect, respond, prevent, and prepare for global health emergencies.

But Laurent notes that speed must be coupled with transparency and relevance.

“Given that clinical trials seek to answer global health questions, there must be shared decision-making around what the most pressing questions are, such that this can inform funder priorities and optimise the applicability, representation, probity, and social impact of trial results,” he said.

“To ensure relevance, people with lived experience of the condition in question should be meaningfully involved in all aspects of a trial, including its design, management, conduct and dissemination.”

He believes that at their core, clinical trials must be participant (or ‘patient’) centred in order to promote trust which can help to boost trial recruitment, limit drop-out, and encourage engagement in future trials.

“Strong engagement of participants at all stages is crucial, for instance by asking them how they like to be communicated with, and when and how they would like to learn of trial results,” he said.

“This feedback loop should extend to capturing and assessing the participants’ experience of taking part in the research, in order to enhance future trial design and delivery.”

He notes that clinical trials of the future must also be transparent, openly detailing methods; for instance, by making templates publicly available to support the planning and reporting of statistical analyses.

“To aid reproducibility of published results, it is also crucial to make data and statistical code available.”

Better representation for all

Finally, he says clinical trials must be representative, which means promoting the participation of people who have historically been excluded.

“It’s important for investigators to ensure diversity among trial participants in terms of race, ethnicity, age, socio-economic status and other characteristics. Unless there is a valid reason not to do so, researchers should include pregnant women in trials, as well as equal percentages of women and men.”

While not all trials will have a positive result, ensuring diversity among participants can not only help to meet the clinical or public health objectives of trials, but can also help to ensure the acceptability of their findings in practice.

“… and means that the research we are conducting will provide answers that will help the whole community, especially those who are currently underserved, which is the essence of the work we do at the Institute.”

To find out more about The George Institute’s work on clinical trials, explore our website, and find out more about Laurent’s work here.