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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

Following the appointment of Bellberry HREC (adults) and Sydney Children’s Hospitals Network HREC (paediatrics) to NSW Health’s Early Phase Clinical Trials HRECs Scheme in November 2018, these HRECs will commence operations as NSW Health’s statewide Early Phase Clinical Trials HRECs from 29 April 2019.

The Early Phase Clinical Trials HRECs Scheme was established to further support NSW’s consistent, high quality scientific and ethics review and approval process for early phase clinical trials in NSW, while supporting the welfare and safety of trial participants.

Early phase clinical trial definition includes all clinical trial phases up to but not including Phase II, including studies with any Phase I component.

Transition arrangements

For early phase clinical trial HREC submissions made prior to 29 April 2019, the ethics review and approval will be accepted by a NSW PHO site without requiring another ethics application to the appointed NSW Health EPCTs HRECs. These applications will not be affected by this Scheme.

On and after 29 April 2019, all early phase clinical trials HREC applications should be submitted to one of the two NSW Health early phase clinical trial HRECs for review and approval before it can be accepted by a NSW Public Health Organisation site, unless under current arrangements of the Scheme involving paediatrics early phase clinical trials.

NSW non-PHOs are also encouraged to use NSW Health’s appointed Early Phase Clinical Trial HRECs for review and approval of early phase clinical trials.

All applications should be submitted via Research Ethics Governance Information System (REGIS).

Senior Executives from sites that are listed on a NSW early phase clinical trial HREC application will be invited to attend the early phase clinical trial HREC meeting as an observer.

More information is available in the frequently asked questions section below.

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.

Age group within the scope of Bellberry HRECs

  • Trials involving adults equal to and greater than the age of 18 years.
  • Combined paediatric and adult trials involving young people and adults equal to and greater than 16 years.

Further information

For further clarification regarding applications or submissions, Sponsors and researchers are encouraged to contact the Bellberry HREC:

Jerneen Williams, Early Phase Clinical Trial Manager

Phone: (08) 8361 3222

Email: JerneenWilliams@bellberry.com.au

 

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.

Age group within the scope of Sydney Children's Hospitals Network HREC

  • Trials involving only children and young people under the age of 18; and
  • Combined paediatric and adult trials involving children and young people under the age of 16 and young adults up to the age of 25.

Further information

For further clarification regarding applications or submissions, Sponsors and researchers are encouraged to contact the Sydney Children’s Hospital Network HREC:

Melinda Giles, EPCTs Research Ethics Officer

Phone: (02) 9845 3105

Email: Melinda.Giles@health.nsw.gov.au

 

Frequently asked questions

What is the definition of an early phase clinical trial (EPCT) that encompasses with respect to the NSW Health Early Phase Clinical Trial (EPCT) HRECs Scheme?

Early Phase Clinical Trial definition includes all clinical trial phases up to but not including Phase II, including studies with any Phase I component.

For more information please refer to the “NSW Health EPCT HRECs Scheme Quick Reference Guide” below.

When will these NSW Health EPCT HRECs be operational?

From 29th April 2019, all EPCT HREC applications should be submitted to one of the two NSW Health EPCT HRECs for review and approval before it can be accepted by a NSW PHO site, unless under current arrangements of the Scheme involving paediatrics EPCTs.

For more information please refer to the “NSW Health EPCT HRECs Scheme Quick Reference Guide” below.

What are the key changes as a result of this Scheme been operational?

NSW Health is excluding all Adult EPCT from the National Mutual Acceptance Model. All new adult EPCT applications proposed to be conducted in a NSW PHO site, must be submitted to Bellberry HRECs for ethics review.

Paediatrics EPCTs with a NSW PHO lead site are required to be submitted to SCHN HREC for ethics review.

For more information please refer to the “NSW Health EPCT HRECs Scheme Quick Reference Guide” below.

Are Paediatrics EPCTs in NSW exempted from National Mutual Acceptance Model?

No, for multi-centred paediatric EPCTs, if an HREC hosted in a specialist paediatric tertiary hospital outside NSW has approved a paediatric EPCT, NSW PHO sites will continue to accept interstate HRECs’ approval in these instances.

For more information please refer to the “NSW Health EPCT HRECs Scheme Quick Reference Guide” below.

What is the age group within the scope of Bellberry HRECs for EPCTs?

Trials involving adults equal to and greater than the age of 18 years; or
Combined paediatrics and adult trials involving young people and adults equal to and greater than 16 years.
Refer to the “NSW Health EPCT HRECs Scheme Quick Reference Guide” for more information.

What is the age group within the scope of SCHN HREC for EPCTs?

Trials involving only children and young people under the age of 18; and
Combined paediatric and adult trials involving children and young people under the age of 16 and young adults up to the age of 25.

For more information please refer to the “NSW Health EPCT HRECs Scheme Quick Reference Guide” below.

What happens to all EPCT applications submitted PRIOR to 29 April 2019?

These applications will not be affected by this Scheme. Ethics review and approval will be accepted by a NSW PHO site for EPCT applications submitted PRIOR to 29 April 2019

Will Bellberry be acceptable as a lead HREC for NSW PHO’s for NON-early phase clinical trials?

No. The EOI, to which Bellberry responded and were successful, was specifically for reviewing early phase clinical trials (EPCTs). There is currently no plan to expand Bellberry’s commission to non-EPCTs.

Where does Bellberry sit at present in the National Mutual Acceptance scheme? Do/will other jurisdictions recognise Bellberry approvals for multicentre trials with centres in their states? Or will multiple HREC approvals be required? For example, if I set up a Phase 1 trial in NSW and obtain HREC approval from Bellberry, can my colleague in Victoria use that approval or does s/he need to go to another NMA HREC?

All private (and many University) sites in NSW and other jurisdictions currently accept Bellberry approvals. This scheme expands the acceptance of Bellberry approvals to EPCTs in NSW public health organisations (PHOs) as well. We welcome PHOs in other jurisdictions to accept a Bellberry-approved EPCT, but this is up to the individual jurisdictions. This scheme does not establish Bellberry as an NMA HREC.

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 month ago