This talk will describe the speed, cost and quality considerations and advantages of conducting early phase clinical trials in Australia. Of particular note are the Clinical Trial Notification (CTN) program which allows for patients to be dosed within 8-10 weeks of document submission to the Ethics Committee (EHRC) for trial approval as well as the R&D tax rebate scheme from the Australian government.
There are several advantages to the CTN program, including reduced documentation requirements for study approval, fast review and approval, and reduced release testing requirements.
Trials conducted in Australia utilizing these more efficient processes meet international quality standards and are often the basis for IND and/or CTA fillings for Phase II trials in the US and EU.
Thank you to PCI Pharma Services for sponsoring this event.