Australia looks to speed clinical trial start-up times
More specifically, the council has released a Good Practice Process to streamline the site assessment and site authorization of trials. According to the NHMRC, two key improvements that will reduce the time taken to begin trials have been proposed by the council’s development group:
- An increased commitment to planning, preparation and ongoing support for clinical trials within institutions where trials are conducted; and
- A change to the order in which the activities within the assessment and authorization process are conducted, whereby key assessment activities occur much earlier.
Pharma companies, clinical researchers and CROs (contract research organizations) have raised concerns about the length of time taken to commence clinical trials in Australia, and particularly about the time taken to complete research governance, the council says.
“The proposed order in which activities can be completed in the Good Practice Process represents a paradigm shift from the way in which the site assessment and authorisation process has traditionally been conducted,” the NHMRC says.
The new guidance offers three main differences between the proposed process and previous methodology:
- The majority of site assessment activities can be conducted not just at the same time as, but prior to, ethical reviews being undertaken;
- Many of these activities can be conducted in parallel instead of sequentially; and
- Some key site assessment activities can be substantively completed in the feasibility assessment stage and then formalized in documentation rather than be delayed until all documentation is submitted.
