The Office for Health and Medical Research has developed a framework to support early phase clinical trials across NSW. Following broad support from the sector and endorsement by local health district and specialty network Chief Executives, the Framework has been approved by the Chief Health Officer.
More than 100 experts across the sector were involved in consultations to inform the design of the Framework.
The framework contains the design of two practical schemes to make NSW a centre of excellence in clinical trials, through the provision of a high quality and efficient environment to conduct early phase trials, with the ultimate aim of improving health outcomes for NSW residents.
The Framework is designed to:
- strengthen the capability in NSW to become a centre of excellence for early phase trials
- support and enable opportunities for residents and the research community across the State to engage in national and international early phase trials
- reduce the administrative burden in the approval and conduct of early phase trials;
- ensure alignment with best practice internationally and nationally.
Overview of the Stages to Develop and Implement the Early Phase Clinical Trials Framework for NSW
|Rapid and high quality approval to commence early phase trials
NSW Health appointed specialist early phase clinical trials Human Research Ethics Committees.
Expression of Interest open to all National Health and Medical Research Council certified Human Research Ethics Committees. Up to five early phase specialised Human Research Ethics Committees will be appointed for NSW.
Human Research Ethics Committees supported by the Office for Health and Medical Research for scientific review, and professional development
Governance: Office for Health and Medical Research, National Health and Medical Research Committee
- host institutions and sponsors have assurance of quality and ethical trial thereby mitigating risk
- guaranteed Human Research Ethics Committee review time (20 days) and frequent committee meetings
- consistency in what is required from applicants and decision making
- specialised review of pre-clinical data
- Human Research Ethics Committee continuous improvement
- recognises National Mutual Acceptance.
|High quality operational conduct of early phase trials
Voluntary quality recognition scheme for early phase clinical trial sites and investigators in NSW
Sites/units and investigators apply for quality recognition if they published meet standards. A central office will provide coordination and support capacity building of sites/units.
Sites/units will either receive quality recognition or be supported if they are working towards it
Governance: Office for Health and Medical Research, Expert Oversight Committee
- host institutions and sponsors have assurance of quality conduct including clinical governance thereby mitigating risk.
- scheme promotes continuous improvement.
- guaranteed site specific Authorisation review time (10 days).
- sites/units have access to common standard operating procedures and capacity building.
- investigators are appropriately qualified and/or are supported.
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