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Early phase clinical trials framework for NSW

The Office for Health and Medical Research has commenced a process to develop a framework and guidelines (framework) for the conduct of early phase clinical trials across NSW.

The framework aims to achieve the vision of NSW as a centre of excellence that provides a high quality and efficient environment to conduct early phase clinical trials, with the ultimate aim of improving health outcomes for NSW residents.

Using accepted international and national guidelines, the Framework will achieve this vision by:

  • Giving assurance to participants and sponsors that early phase clinical trials are being undertaken to the highest safety and quality standards;
  • Attracting sponsors, contract research organisations and researchers to NSW to conduct early phase trials;
  • Enabling appropriate scientific review of early phase trials;
  • Improving the efficiency of the ethics and governance approval processes for early phase trials; and
  • Supporting sites in the management and conduct of early phase trials.

Everyone involved in clinical trials in NSW will have an opportunity to provide input on the draft Framework during the open consultation stage in October. If you are interested in receiving alerts and updates on the consultation phase, please email earlyphasetrials@moh.health.nsw.gov.au.

For more information about the initiative, see the OHMR website: http://www.health.nsw.gov.au/ohmr/Pages/early-phase-clinical-trials.aspx.