There was a time when Jayden Rogers had to explain to potential clients where Australia was and why they should conduct clinical trials here. Today, Australia is known as one of the best places in the world for clinical trials. This is in part due to the high-quality work undertaken by Rogers’ company, Linear Clinical Research.
Linear is an Australian not-for-profit organisation offering Phase I to Phase III clinical trials. To date, Linear has carried out over 420 studies in 20 therapeutic areas. It has worked with more than 300 sponsors from 18 countries. During the pandemic, the company saw record patient enrolments. It undertook over a dozen trials for COVID-19 therapeutics, two of which are now approved.
‘Australia has a well-deserved reputation as a world leader in clinical trials,’ says Rogers, Linear’s CEO. ‘We have a high-quality, advanced healthcare system, brilliant scientists and clinicians, and excellent R&D. Our streamlined regulatory approval process and generous research incentives also support international companies to conduct trials here.’
Tech innovation supports world-class trials
Founded in 2010, Linear has 2 state-of-the-art facilities in Western Australia. One of these is in the QEII Medical Centre, the largest medical precinct in the Southern Hemisphere.
Linear has a strong focus on Phase I healthy volunteer and Phase I cancer trials. The company has more than 100 early-phase cancer trials in its portfolio. It has one of the most active cancer trials team in the Asia-Pacific region.
Later in 2023, Linear will open a dedicated clinical trial private hospital for early-phase cancer trials. This will be the only one of its kind in Australia and it will triple Linear’s existing capacity.
Innovation has also played a part in Linear’s success. In 2017, the company was the first in Australia to install the eSource platform to capture data at the point of entry. It has also invested in telemetry and technology to monitor vital signs remotely. This investment in technology came to the fore during the pandemic.
‘Because we had electronic systems in place, we were able to switch to remote monitoring in just 7 days,’ says Rogers. ‘Our clinicians in Australia and clients in the US, Europe and China could view trial data in real time. It’s a collaborative way to run clinical trials.’
Clinical trials during COVID-19
Finding clinical trial participants during the pandemic was not an issue. In Western Australia, there is strong reach into many patient groups which are often consolidated into a small number of hospitals. This supports strong patient recruitment for clinical trials.
Linear also has over 40,000 healthy volunteer participants in its database. Australia’s multicultural population – 29% of citizens are born overseas – ensures a diverse patient cohort for clinical trials.
‘We delivered record enrolments for our cancer trials,’ says Rogers. ‘These patients would not have received treatment in other facilities. And we’re seeing amazing response rates. Up to 75% of patients observe some form of response with a small number experiencing complete responses (full remission) as a result of new therapeutics. It’s lifechanging.’
Linear also deployed its capabilities to support COVID-19 vaccine and therapeutic trials. The company worked with Chinese biotech Clover to undertake Phase I clinical trials for a vaccine candidate. It had the trial up and running in two weeks following ethics submission. The Phase I trial recruited 140 volunteers as a single site. This enabled a subsequent global Phase II/III trial that went on to demonstrate successful protection against COVID-19.
‘The Clover vaccine is now among the group of vaccines used in China,’ says Rogers. ‘It was thrilling to play a role in its development.’
Australia’s accelerated trial approval process
Linear undertook more than a dozen COVID-19 trials and prophylactic studies across a range of therapeutic modalities from 2020–2022. One of these was with Stanford University to trial an antibody to prevent COVID-19.
‘We worked around the clock with the Stanford researchers to help design the protocol,’ says Rogers. ‘Then we obtained ethics committee approval within 15 days, recruited patients and had the trial running within 20 days. It was the quickest clinical trial Linear has ever done. It is probably one of the quickest clinical trials in history, from the point of engagement to clinical execution and the delivery of data.’
Linear works with Bellberry, an organisation providing scientific and ethical review of human research projects. During the pandemic, Bellberry had an accelerated approval process for COVID-19 therapeutics and vaccines.
‘Australia’s pragmatic regulatory environment is one of our key strengths,’ says Rogers. ‘The Therapeutic Goods Administration delegates trial reviews to human-research ethics committees like Bellberry. This speeds approval times so clinical trials can be set up quickly but safely.’
Austrade paves entry into China
Almost all of Linear’s clients are international pharmaceutical or biotech firms. Most of them are from the US, followed by China and the EU. Rogers says Austrade was instrumental in helping Linear enter the Chinese market in 2017.
‘We’ve had tremendous support from Austrade over years,’ says Rogers. ‘The on-the-ground support in China was an important aspect of our growth in that market. Their staff went above and beyond. I would happily recommend Austrade to any business wanting to expand their overseas markets.’
Keeping innovation on the agenda
The past few years have seen major changes in therapeutics and approaches to clinical trials.
‘We’re seeing new molecules being tested, including bi-specific antibodies and drugs that target certain mutations based on genomics,’ say Rogers. ‘COVID-19 saw a shift to new treatments for infectious diseases and respiratory viruses. We’re seeing more targeted therapeutics, particularly mRNA therapeutics and cell therapies.
‘The world made a vaccine for COVID-19 in 12 months, thanks to research, industry and government working together,’ says Rogers. ‘At Linear, we want to keep pushing the innovation agenda. It’s the only way we can keep creating drugs that save lives.’
Read more about why Australia is a go-to destination for clinical trials.
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Published: 30 March 2023