The changing face of clinical trials

The vast majority of researchers aren’t uploading important information about their clinical trials to databases like the Australian New Zealand Clinical Trials Registry (ANZCTR).

This was discovered as part of an extensive research paper published in The Medical Journal of Australia. The research looked at Australia’s clinical trial landscape from 2006 to 2020.

“We did this very comprehensive review of clinical trials that have been undertaken in Australia in the last 15 years,” says University of Sydney biostatistician Dr Lene Seidler. “We found researchers need to get better in working together and collaborating and sharing the data. The infrastructure has recently been built for that in Australia, but what we haven’t seen is governments pushing for that infrastructure to be used.”

The researchers looked at data from more than 18,000 trials and almost 8.7 million people from and the ANZCTR.

Lene sidler
Lene Seidler

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

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

From 2006 to 2020, the most frequently studied health conditions based on number of trials were cancer (20%),_mental health (13%) and cardiovascular diseases (10%). In the last five years, the number of trials focused on neurological conditions and public health topics have overtaken trials on cardiovascular diseases, though the difference is small.

While we’re punching above our weight when it comes to clinical trials, there are a few things that the researchers think we can improve.

During 2006–20, the size of clinical trials dropped significantly – from 128 median participants in 2006 to 80 participants in 2020.

“There’s no right amount – it really depends on the type of trial,” says Seidler. “But overall, we would like to see bigger trials, particularly because they’re getting smaller.”

The researchers also identified an inability to measure the diversity in clinical trials. The information was not collected, and therefore could not be assessed in their paper. “We are unable to provide an overview of trial participation in Australian trials based on sex, gender, cultural, ethnic and linguistic diversity because this information is not collected consistently in most public resources, including trial registries.”

This underscores a larger issue that the team found – although clinical trials have to be registered at the 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 a normally opaque area.

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

“We need policies from funders and the organisations that conduct clinical trials to mandate this requirement,” says 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.”

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

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

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

The economic investment in Australian trials is substantial, with an estimated $1.4 billion of public and private funding committed in 2019.

Trials in Australia are conducted through universities, hospitals, individuals, government, charities, and commercial entities. Just under half (45%) of trials registered between 2006 and 2020 declared industry involvement (ie, industry funding, sponsorship/collaboration, or combination).

The researchers says industry involvement shows why government funding is important.

“Industry involvement typically also means industry funding; 93% of trials with industry involvement were also funded by industry. Trials with industry involvement differ in their characteristics from non-industry trials; for instance, they are more likely to study treatments rather than prevention or education interventions.

“Targeted public funding schemes (eg, Medical Research Futures Fund Australia) can support the prioritisation of diverse research themes such as rare diseases and public health interventions. Thus, a combination of public- and industry-funded trials is important to sustain the breadth of trials in Australia.”

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