Towards innovative, more efficient and representative trials
To mark International Clinical Trials Day, Clare Arnott, Co-director of the Better Treatments program at The George Institute, shares her thoughts on the impact of the pandemic, current trends and challenges, as well as innovations and her hopes for the future of trials.
Where did your journey into clinical trials begin?
I am a cardiologist by background and remember feeling frustrated about the quality of the available evidence in my field and the fact that sometimes I couldn't really give my patients meaningful answers. I was involved in some small studies at the time and began looking for an opportunity to take my research to the next level. After joining The George Institute in 2018, I got involved in some robust national and international clinical trials that were designed to answer important questions. Since then, I've been lucky enough to work on a wide range of large trials that I believe are going to be quite important for my patients.
How has the pandemic impacted clinical trials?
I think the pandemic has taught us a lot and really made us think about how we can conduct research or deliver clinical care differently. It forced us to introduce innovations like telehealth and virtual follow-ups, and we’ve also been able to decentralise some of the data gathering through things like wearable devices and providing participants with equipment to test their blood at home. This has opened trials up to a broader and more diverse demographic, who previously may not have been able to participate. People who could not physically go to appointments like those in carer roles, those living in remote areas, or people with mobility disabilities, can now participate remotely.
I also think it has raised the profile of research in the general community by putting health and research at the forefront of people's thoughts. Suddenly people could tangibly see how important research is because they saw new vaccines or treatments being announced on the nightly TV news. It's made people more positive towards research and predisposed to getting involved with clinical trials, as well as advocate for research, which is great.
What are some interesting trends you're seeing globally in clinical trials?
The more clinical trials that I’m involved in, the more I realise that our current models are unsustainable. Traditional clinical trials are expensive, labour intensive and carbon-intensive - we just don't have the time, infrastructure or funding to carry out all the research that should be done. What's exciting for me are the new, more efficient types of trials that involve decentralised or remote models, risk-based monitoring, e-consent and using routinely collected data or wearable devices to streamline the way that we interact with and monitor trial sites. These sorts of innovations enable us to conduct trials more rapidly, efficiently and cost-effectively, as well as increase the diversity of trial populations.
Another big thing for me is the role clinical trials can play in planetary health research and the complex interplay between climate change and health. We know that changes in air and water quality and temperature due to climate change have far-reaching health implications, and trials can play a critical role in understanding these dynamics and coming up with solutions. Overall, the health sector is the fifth largest emitter of carbon globally, so we also need to look inwards and come up with strategies to reduce the carbon footprint of our own work. Answering important questions with minimal environmental impact is something I'm very passionate about. At The George Institute, we’re developing a process to measure greenhouse gas emissions generated by our research and creating a toolkit to support decarbonisation and achieving net zero emissions in clinical trials.
What are some of the key challenges facing clinical trials?
Participant recruitment and the diversity of trial populations are huge challenges - particularly when it comes to cardiovascular trials. We tend to predominately recruit Caucasian middle-aged men, which is not representative of our entire community and frankly not good enough. Women, First Nations and culturally and linguistically diverse people have been left behind. The George Institute is trying to address this by reporting on the diversity of trial populations and working with consumer groups and community members to understand the barriers to inclusion and figuring out ways to better represent actual populations. We’re developing co-design processes so that we ask questions with our trials that are relevant to the communities where they are conducted. We then work together throughout the trial to the implementation phase and delivery of information back to the communities. Certain programs within the Institute, such as the Aboriginal and Torres Strait Islander Program are leading the charge in developing and applying culturally appropriate methods to conducting research.
What kind of trial innovations is the Institute exploring and why?
For the last couple of decades, The George Institute has had a very strong track record in the conducting large-scale traditional clinical trials. Over the last two-to-three years, however, we've realised that we need to grow as an institute and innovate if we want to remain at the cutting edge. So together with partners and collaborators, we've started to look at innovative trial designs such as platform trials, decentralised trial models, focussing on trials offering a 'package of interventions', using Artificial Intelligence to improve trial efficiency, and developing a whole suite of strategies for monitoring sites using risk-based monitoring. We’ve also established Join Us - a national registry of people who have indicated they're interested in being involved in research. This registry aims to speed up trial recruitment because essentially you already have a list of people who have indicated that they're willing to participate.
Where do you hope clinical trials would be in five years? What kind of changes would you like to see?
In five years, I hope we're conducting clinical trials with complete transparency about their carbon footprint,and we have mitigated their environmental impact as much as possible so we're not also contributing to adverse health outcomes. I hope that we're able to conduct trials that are truly representative of the communities they’re targeting, and they’re carried out in a rapid and cost-effective manner.
For more information on what we’re doing to reduce the carbon impact of health research, visit