The number of biotech-sponsored clinical trials in Australia has grown by more than +10% on average each year between 2017 and 2019 and generally, Australia is well regarded as a jurisdiction to commence first-in-human trials (FIH) and early-phase trials. In fact, a US Investigational New Drug (IND) submission is not necessary to initiate FIH clinical trials in Australia. Another reason sponsors are flocking to the APAC region for clinical trials is that FIH trials in Australia are of high quality and are transferrable to other regulatory agencies in support of later-phase clinical trials.
Australia also has an attractive cashback incentive for all R&D work. If a company declares less than $20 million of annual revenue, it will be eligible for a refund of 43.5 cents back on every dollar spent on R&D in Australia, via a rebate at the end of the fiscal year.
Moreover, clinical sites across Asia and Australia have adapted well to the COVID-19 situation, with all top ten clinical sites within Australia still open for either on-site or remote monitoring.
Another appealing feature of coming to Australia is the rapid start-up period – for trials run at private sites, this takes approximately six to eight weeks from application, and approximately 12 weeks for a hospital base or public site.
Clinical trial dossier
Another benefit of choosing Australia over the US or Europe is that the clinical trial application dossier is not required in Australia. This means the amount of CMC information required to be presented is reduced. In fact, the only CMC information that is evaluated is that which is presented in the investigator brochure.
However, sites and regulatory bodies in Australia do have the same international quality standards as the US and Europe. With safety, the expectation is that the safety data is equivalent to that which would be acceptable elsewhere in the world.
Asia-Pacific biotech specialist CRO Novotech has released a new webinar about the advantages of conducting FIH and early-phase clinical trials in Australia. The panel included leading key opinion leaders from Australia as well as a US-based biotech sponsor and provides the latest and best-in-class info on first-in-human and early-phase trials.