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In association with Novotech
  1. Accelerating Clinical Trials
August 17, 2020updated 11 Sep 2020 9:53am

Is Australia the future for successful first-in-human clinical studies?

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.

Free Whitepaper
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Evolution of clinical trials in the Asia Pacific region compared to the US and the EU5

Over the last five years, the global clinical trial landscape has been transformed. Between 2017 and 2020, 70,000 new clinical trials were registered across the APAC region, the US and the EU5. The APAC region contributed more than 50% of these trials and saw the most growth. APAC, especially China, is emerging as the hot spot for conducting clinical trials. This whitepaper takes a deep dive into why China has been attracting more foreign biopharma companies in recent years. It presents an in-depth analysis of the evolution of clinical trials in the APAC region compared to the US and EU5.
by Novotech
Enter your details here to receive your free Whitepaper.

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.

Watch the full webinar here

Free Whitepaper
img

Evolution of clinical trials in the Asia Pacific region compared to the US and the EU5

Over the last five years, the global clinical trial landscape has been transformed. Between 2017 and 2020, 70,000 new clinical trials were registered across the APAC region, the US and the EU5. The APAC region contributed more than 50% of these trials and saw the most growth. APAC, especially China, is emerging as the hot spot for conducting clinical trials. This whitepaper takes a deep dive into why China has been attracting more foreign biopharma companies in recent years. It presents an in-depth analysis of the evolution of clinical trials in the APAC region compared to the US and EU5.
by Novotech
Enter your details here to receive your free Whitepaper.

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