The changing face of clinical trials in Australia

Most researchers do not upload important information about their clinical trials to databases such as the Australian New Zealand Clinical Trials Registry (ANZCTR).

This was discovered as part of an extensive research paper being published in the Australian Medical Journal. The study looked at the Australian clinical trial landscape from 2006 to 2020.

“We did a very comprehensive review of the clinical trials that have been conducted in Australia in the last 15 years,” said University of Sydney biostatistician Dr Lene Seidler. “We found that researchers needed to get better at collaborating and collaborating and sharing data. Infrastructure has recently been built for that in Australia, but what we haven’t seen is the government pushing for that infrastructure to be put to use.”

The researchers looked at data from more than 18,000 trials and nearly 8.7 million people from ClinicalTrials.gov and ANZCTR.

“Australian trial activity (number of trials per capita) compares favorably with other OECD countries, with more activity in Australia than in France, Germany and the United States,” the researchers wrote in their paper.

“Few countries have more activity than Australia, including Belgium and Denmark.”

From 2006 to 2020, the health conditions most frequently studied by trial number were cancer (20%), mental health (13%) and cardiovascular disease (10%). In the past five years, the number of trials focused on neurological conditions and public health topics has surpassed those on cardiovascular disease, although the differences are small.

While we’re well over our weight when it comes to clinical trials, there are a few things researchers think we could improve on.

During 2006–2020, the number of clinical trials fell significantly – from an average 128 participants in 2006 to 80 participants in 2020.

“There’s no exact number – it really depends on the type of trial,” Seidler said. “But overall, we would like to see a larger trial, especially as it gets smaller.”

The researchers also identified an inability to measure diversity in clinical trials. Information is not aggregated, and therefore cannot be assessed in their paper. “We are unable to provide an overview of trial participation in the Australian trial based on gender, gender, culture, ethnicity and language diversity because this information is not collected consistently across most public resources, including trial registries.”

This underscores the larger problem the team found – although clinical trials must be registered with ANZCTR, scientists regularly do not report their results, or their reporting protocols.

This means that there may be overlap between studies, plus open science allows more people to have an understanding of areas that are normally opaque.

Fully reporting of findings from clinical trials is more common in some other countries, such as the UK’s ISRCTN registry.

“We need policies from funders and organizations conducting clinical trials to mandate these requirements,” said one of the researchers, Dr Melina Willson. “By doing so, we will have a more complete picture of the benefits and risks of healthcare interventions to better inform healthcare practice and policy.”

MJA late last year also surveyed reporting of adverse reactions in clinical trials.

Finally, the team also looked at the differences between industry-led and government-led clinical trials, finding that nearly half of the trials were funded by industry.

Government funding is important because it usually focuses on less profitable areas, such as indigenous health and rare diseases.

The economic investment in the Australian pilot has been substantial, with an estimated $1.4 billion in public and private funding committed in 2019.

Trials in Australia are being conducted through universities, hospitals, individuals, governments, charities and commercial entities. Nearly half (45%) of trials registered between 2006 and 2020 claimed industry involvement (i.e. industry funding, sponsorship/collaboration, or a combination).

Researchers say industry involvement shows why government funding matters.

“Industry involvement usually also means industry funding; 93% of pilots with industry engagement are also funded by industry. Experiments with industry involvement differ in characteristics from non-industry trials; for example, they are more likely to study medicine than preventive or educational interventions.

“Targeted public funding schemes (eg, Australia’s Medical Research Futures Fund) can support the priority of multiple research themes such as rare diseases and public health interventions. Therefore, a combination of publicly funded and industry-funded trials is critical to sustaining trial breadth in Australia.”

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