1. Early Phase Clinical Trials Framework
Dr Kerry Chant, Chief Health Officer and Deputy Secretary Population and Public Health
Drug Development 2017, 23 March 2017

2. Clinical trials – priority for NSW Health
Clinical trials play an important role in the health system
Clinicians in research-active institutions achieve better patient outcomes
Patients gain access to new medicines and innovations
Clinical trials embed research culture into the health system
Clinical trials are a globally competitive environment
NSW is competitive in many respects
Commitment to strengthening the clinical trial environment
Clinical trials are a priority for NSW Health
Within NSW Health there is a recognition of the importance of clinical trials and their role in the health system.
This impacts clinician researchers, patients, and the system as a whole.
Patients gain access to new medicines
Clinicians in research active organisations achieve better outcomes for patients
Clinical trials help to embed a culture of research across the health system
We recognise that clinical trials are a globally competitive environment,
NSW offers a competitive advantage because of its high quality clinicians and academics, diverse population, mix of rural and metro settings, and strong clinical networks.
For NSW to remain competitive on an international level we are committed to strengthening the clinical trials environment across the state.

3. Why focus on Early Phase Clinical Trials?
Competitiveness
23% of new clinical trial notifications in Australia come from NSW
Approximately early phase trials are approved in NSW each year
To remain internationally competitive, NSW must attract sponsors through
timely ethical and governance review, and
consistently delivering a high standard of conduct
Getting early phase trials right will have flow on effects for attracting later phase trials to NSW
Rationale for focus on early phase trials - competitiveness
Less than a quarter of new trials in Australia are in NSW
Data from clinical trial registries and our own data from AU RED indicate early phase clinical trials are approved each year in NSW
Early phase clinical trials is an internationally competitive environment – to remain internationally competitive, NSW has to offer fast and consistent trial start up times, and high quality conduct
Attracting early phase trials has flow on effects to later phase trials – sponsors recognise NSW as an attractive destination for clinical trials

4. Why focus on Early Phase Clinical Trials?
Quality and safety
Lack of current, clear and consistent guidance on how to approve early phase trials and monitor their conduct
The scientific and ethical review of early phase clinical trials requires high-quality, multidisciplinary, specialist expertise
Concern from all stakeholders about serious adverse events, in the light of recent international events in Phase I trials
Current environment allows for potential variability in review and conduct of early phase trials across the state
Rationale for focus on early phase trials – quality and safety
Feedback from stakeholders that there is a lack of current, clear and consistent guidance on how to approve early phase trials to commence and monitor their conduct in NSW (or Australia)
The scientific and ethical review of early phase trials requires high-quality, multidisciplinary, specialist expertise – more so than for later phase trials
There is concern from all stakeholders about serious adverse events, in the light of adverse events in healthy volunteers participating international Phase I trials (France and UK)
The current environment allows for potential variability in review and conduct of early phase trials across the state

5. Early Phase Clinical Trials Framework
Vision:
NSW is 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.
The Ministry of Health, though OHMR, has undertaken a consultative process – engaged with over 100 stakeholders through workshops & public consultation – to develop a Framework to support early phase trials across NSW.
The Early Phase Clinical Trials Framework aims to improve the state’s competitiveness, AND quality and safety standards.
Vision
The Framework sets out to achieve the vision of NSW as a centre of excellence for early phase clinical trials
Through implementation of this Framework, we aim to ensure high quality and efficiency in early phase trials across the State
The ultimate aim is to improve health outcomes for NSW residents

6. Early Phase Clinical Trials Framework
The Framework comprises two key elements:
NSW Health appointed specialist early phase clinical trial Human Research Ethics Committees
Voluntary quality recognition scheme for early phase clinical trial sites and investigators in NSW
The Framework has two key elements designed to support the REVIEW and CONDUCT of early phase trials respectively:
NSW Health appointed specialist early phase clinical trial Human Research Ethics Committees
Voluntary quality recognition scheme for early phase clinical trial sites and investigators in NSW

7. NSW Health appointed specialist early phase clinical trials HRECs
Specialist committees will be appointed to review all early phase clinical trials
All NHMRC-certified HRECs in Australia are eligible to apply to be a specialist committee through an EOI process, including PHO, private and interstate HRECs
Mandated for use where NSW PHO sites are involved and encouraged for non-PHOs
Criteria include guaranteed review time and core specialist skills
Likely that only a small number of committees will meet criteria
Overview of HREC scheme
Specialist committees will be appointed (through an EOI process) to review all early phase clinical trials
All NHMRC-certified HRECs in Australia are eligible to apply, including PHO HRECs, private HRECs and interstate HRECs
Their use will be mandated for ethics review of early phase trials involving PHO sites, and their use encouraged for trials in non-PHO sites
Committees must meet criteria including commitment to a 20 day review period and demonstration of access core skills
Likely that only a small number of committees will meet criteria to be appointed. Given approximately early phase clinical trials go through ethics review each year, we envisage five committees will be sufficient to handle the workload, the number of committees appointed will be reviewed post implementation

8. Voluntary quality recognition scheme
Quality recognition scheme will recognise sites and investigators that have the capability to conduct early phase trials at a high standard
All clinical trial sites and units, and associated investigators, in NSW eligible to apply for voluntary recognition
Sites and investigators will either:
meet criteria and are recognised for 3 years, or
enter an agreement to build capacity and work towards recognition
Support provided by an Expert Oversight Committee to set standards and monitor performance
Voluntary quality recognition scheme overview
The other element of the Framework is the Voluntary quality recognition scheme for sites and investigators
Sites can apply for recognition and will be assessed on their ability to conduct early phase trials at a high standard
This scheme is modelled on a system in UK led by MHRA where they have over 10 years experience.  The UK system was developed in response to an incident in the UK in 2006
All sites in NSW are eligible to apply
The scheme will be supported by technical experts through an Expert Oversight Committee that determines standards and monitor performance

9. Clinical trials: OHMR initiatives
OHMR’s clinical trial initiatives aim to:
Reduce study start-up times
Ethics & governance KPIs embedded in LHD Service Agreements; Expand single ethical review and National Mutual Acceptance; reform Site Specific Assessment processes
Improve clinical trial coordination
Clinical Trial Coordination Units to reduce administrative load; central coordination of governance (e.g. SEBS Panel)
Improve trial access for all NSW residents
Recruitment KPIs in LHD Service Agreements; Effective consumer engagement; embedding research as essential health system business (benefitting patients)
Make NSW an attractive clinical trials environment
Enhanced data and knowledge systems through REGIS implementation: improved data linkage capabilities
Implementation of the Early Phase Clinical Trials Framework is one initiative in a broader context of work that the Office for Health and Medical Research is undertaking
More widely, OHMR works collaboratively with LHDs in developing its work programme, and directly influences national initiatives such as those from NHMRC, CTJWG (Clinical Trials Jurisdictional Working Group) and others with the aim of making NSW a global leader in clinical trials
OHMR initiatives in this space touch on four areas:
Reducing study start-up times
Specific KPIs for clinical trials ethics and governance review timelines have been embedded into Service Agreements with LHD, SHN and NSW Ambulance Chief Executives.
National Mutual Acceptance of scientific and ethical review of human research conducted at sites in more than one jurisdiction was successfully expanded beyond clinical trials to all human research.
Site specific assessment process and form to become simplified – in conjunction with introduction of REGIS – one SSA only to be required per LHD
Improving clinical trial coordination
OHMR developing a proposal to introduce clinical trial coordination units to facilitate four broad roles, including a start up specialist, clinical trials manager, costings and quality.
Improving trial access for all NSW residents
Clinical Trial Recruitment Monitoring Measures assess recruitment to time and to target have been embedded into LHD & SHN Chief Executives’ Service Agreements.
Making NSW an attractive clinical trials environment
All underpinned through a flexible, intuitive Research Ethics and Governance Information System, to manage applications, ongoing monitoring and reporting.
OHMR coordinating introduction of national single ethical review for data linkage projects through interjurisdictional links.

10. Clinical trials: OHMR initiatives
Supporting clinical trials
Biobanking
Improving the quality and capacity in biobanking; a new state-wide facility opening in July 2017; education and training for biobanks and better integration with the pathology networks
Data linkage
NSW Health data sets available through CHeReL; collections hosted in the new Biobank facility will have data linkage for follow up data
New state-wide facility, with advanced storage robotics, opening in July 2017; first of its kind in Australia; integrated with the NSW Health Pathology networks; statewide reach into every public hospital
Education and training is being made available to all NSW Biobanks through a certification scheme based on international best practice; Over 20 biobanks are actively taking the education modules. There will be continual development of the content based on changes in best practice and registrants kept informed.
CHeReL provides access to NSW Health data sets (e.g. Admitted Hospital Patient Data, Cancer Registry, Ambulance data); For collections hosted in the facility; we will be providing data linkage to these NSW Health datasets (through the CHeReL system) to enable follow up data to be collected.

11. Key messages This Framework will:
Make NSW an attractive destination for early phase trials through
reducing the time and administrative burden in the approval of early phase trials
assuring a high quality standard of conduct
Give participants and host institutions assurance that early phase trials are as safe as possible
Complement existing national process that support clinical trial processes in Australia (e.g. National Mutual Acceptance and TGA’s Clinical Trial Notification scheme)
Key messages
The Early Phase Clinical Trial Framework
Will make NSW an attractive destination for early phase clinical trials by
reducing the time and administrative burden in the approval of early phase trials
Assuring a high quality standard of conduct
Give participants and host institutions assurance that early phase trials are as safe as possible
Complement existing national processes that support clinical trial processes in Australia (e.g. National Mutual Acceptance and TGA’s Clinical Trial Notification scheme)

12. Key messages
Wider context of a strong and growing clinical trials environment across the state:
Initiatives addressing clinical trial start up times, coordination and access
Biobanking initiatives to improve quality and capacity across the state
Data linkage capacity which provides access to health and related data sets for long term follow-up
Potential for scale up to all clinical trials if successfully implemented
The Framework will be implemented in the wider context of a strong and developing clinical trials environment across the state:
Initiatives addressing clinical trial start up times, coordination and access will make NSW a destination of choice for clinical trials
Biobanking to improve quality and capacity across the state
Data linkage capacity which provides access to health and related data sets for long term follow-up
There is potential to extend and expand the Framework to cover all phases of clinical trials, if successfully implemented for early phase trials, having further impact on the attractiveness of the state as a clinical trial destination

13. Office for Health and Medical Research
Contact details Office for Health and Medical Research NSW Ministry of Health Level 5, 73 Miller St North Sydney NSW 2060
Topic
​Name
​Phone ​
General enquiries
​Tim Mackay
​9391 9228
​Early Phase Clinical Trials Framework
​Christine Whittall ​
Biobanking and data linkage
Brett Reed
​Ethics and Governance
​James Cokayne
9391 9920
The Office for Health and Medical Research are your primary point of contact for navigating the NSW health system, relating to research
Contact details for the office are below