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NSW Early Phase Clinical Trials

Key dates

  • 28-SEP

    Expressions of Interest close

  • 19-OCT

    HREC interviews

Dr Martina Sanderson-Smith and Dr David De Oliveira at IHMRI. Photo credit Todd Hardingham

The NSW Health Early Phase Clinical Trials HRECs Scheme was established to support NSW’s consistent, high quality ethics approval process for early phase clinical trials.

NSW Health has appointed the following HRECs to the Scheme:

  • Bellberry Limited (adults)
  • Sydney Children’s Hospitals Network HREC (paediatrics).

This initiative will further support NSW’s vibrant early phase clinical trials environment and position NSW as a destination of choice for early phase trials.

These HRECs will provide safe and high quality scientific and ethics review of all applications within 30 working days, with a target to work towards 20 working days.

Over the coming months, the Office for Health and Medical Research will work closely with these two organisations to transition them to be statewide HRECs for NSW for early phase clinical trials in early 2019. Further information will be provided to stakeholders once the commencement date is confirmed.

Bellberry Limited (adults)

About Bellberry Limited

Bellberry Limited is a national, independent not-for-profit organisation providing streamlined scientific and ethical review of human research projects across Australia. The organisation currently hosts eight HRECs. It has extensive experience in providing ethics review and has rapid access to relevant scientific experts and specialists for early phase clinical trials.

For more information visit the Bellberry Limited website

Sydney Children's Hospital Network HREC (paediatrics)

About the Sydney Children's Hospital Network HREC

The Sydney Children’s Hospital Network Human Research Ethics Committee is responsible for ensuring the ethical and scientific acceptability of research conducted at sites within the Network and other paediatric specific research referred to it by any public health organisation from NSW, ACT, VIC, QLD and SA. It has extensive experience in providing ethics review and has rapid access to relevant scientific experts and specialists for paediatrics early phase clinical trials. The Sydney Children’s Hospital Network HREC is appointed as a specialist paediatric early phase clinical trial HREC.

For more information visit the Sydney Children’s Hospital Network HREC webpage.

About the Framework

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.

Overview of the stages to develop and implement the Early Phase Clinical Trials Framework for NSW

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.

Framework benefits

Goal one

Rapid and high quality approval to commence early phase trials.

How the Early Phase Clinical Trial Framework supports the goal

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.

Benefits

  • 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.

Goal two

High quality operational conduct of early phase trials.

How the Early Phase Clinical Trial Framework supports the goal

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.

Benefits

  • 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.

Updated 1 week ago