Slow study start-ups and poor patient communication holding back Aussie trials sector

Complex regulations and a lack of patient awareness about drug research is stopping the Australian trials sector making the most of potential opportunities according to research by MTP Connect.

The organization – an Australian Government-backed non-profit to promote the research sector – made the comments in a recent study, in which it argued the country’s ethnically diverse population holds significant recruitment benefits.

“Australia has a significant opportunity to capitalize on its diverse and multicultural population to attract more trials, recruit more participants, and ultimately serve and improve the health outcomes for more of Australia's population, if it can effectively engage and support their participation and involvement in trials,” said the authors.

At present only around 5% of global industry-sponsored clinical trials include an Australian research site. Part of the reason for this under representation – the authors say – is the relative complexity of the country’s regulations on study start up.

“Australia has a strong global reputation in supporting early phase (Phase I and II) trials, but we have not had similar success in attracting the larger, more complex Phase III and IV trials.

“In order to grow Australia’s global share of Phase III and IV trials, it is critical to continue to streamline our ethics processes towards a true, single ethical review across all jurisdictions. The country also needs to streamline site governance approval processes to improve consistency from site to site and study to study.”

Participation rates in Australia are also lower than elsewhere with only around 90,000 people take part in studies each year. The MTP team suggested that to change the situation sponsors and contract research organizations (CROs) need to get better at informing potential participants about studies.

“Patient awareness and participation in clinical trials in Australia still lags countries such as the UK by a significant level. Australia has a diverse, multicultural population that could be further leveraged to attract more global clinical trials as companies are looking to demonstrate the efficacy of their novel medicines and devices in diverse populations.

“In order to do this, significant investment in patient awareness and engagement is required. Particularly, we need to engage with our culturally and linguistically diverse (CALD) populations and Aboriginal and Torres Strait Islander communities to improve awareness and understand and address their barriers to participation.”