Universities increasingly take lead on Australian clinical trials

Australian universities have accepted custodianship of clinical trials over the past decade and a half, a new study has found.

In an analysis of more than 18,000 clinical trials conducted over 15 years, Sydney researchers tracked the increasingly prominent role being played by universities.

In 2006, universities hosted 66 of the 362 investigations listed that year on the Australian New Zealand Clinical Trials Registry (ANZCTR) – a proportion roughly on par with other types of sponsors, such as hospitals, government agencies, commercial outfits and individual research leaders.

By 2019, they were sponsoring around 450 clinical trials a year – more than twice as many as hospitals or individual investigators, three times as many as private companies and nine times as many as government.

University of Sydney biostatistician Lene Seidler said clinician researchers were relying on university infrastructure and expertise for help in testing their ideas for new therapies, surgical procedures, devices, rehabilitation strategies and preventive health measures.

Dr Seidler said medics in hospitals often ran their tests through Sydney’s Clinical Trials Centre, where she works as a senior research fellow, regardless of whether they had university affiliations.

In the second report of its kind, Dr Seidler and colleagues analysed 12,000 mostly Australian-based trials listed on the ANZCTR between 2006 and 2020. The team also crunched data on another 6,400 mostly multinational trials that included Australian participants and were registered on the US ClinicalTrials.gov platform.

The study found that on a per-capita basis, Australia ran more clinical trials than many other Organisation for Economic Co-operation and Development countries – including research heavyweights such as Germany, Japan, the UK and the US – and devoted particular attention to major health issues like cardiovascular disease and cancer.

The analysis revealed a shift towards smaller trials over the 15 years, with the average sample size declining from 128 subjects to 80. This reflected a growing proportion of early-phase drug-safety trials, better targeting of participants and more efficient methodologies.

But the study found a dearth of data on participant characteristics like sex, gender, ethnicity and cultural and linguistic background. Dr Seidler said this undermined a push for “health equity” through diversity of subjects. “Historically, we don’t have enough female representation in clinical trials or representation of people with co-morbidities that often have the worst outcomes.”

She said the registry had largely been set up for accountability reasons, not to capture information about participant traits, and teams often registered their studies before recruiting subjects.

“We would certainly like to see more information being collected on diversity [of research subjects],” she said. “It’s something we are exploring.”

While the analysis was unable to determine how many indigenous Australians had participated in the trials, it found that less than 1 per cent of studies had focused exclusively on indigenous health issues – a low proportion given the “big burden of disease” among Aboriginal and Torres Strait Islander people, Dr Seidler said.  

She said schemes such as a recently announced A$22 million (£11 million) allocation for indigenous-led studies, bankrolled through the Medical Research Future Fund, would help. “There’s certainly great public funding initiatives happening in that space.”

john.ross@timeshighereducation.com