Early Phase Clinical Trials Framework Dr Kerry Chant

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

Clinical trials – priority for NSW Health l 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 l Clinical trials are a globally competitive environment – NSW is competitive in many respects – Commitment to strengthening the clinical trial environment

Why focus on Early Phase Clinical Trials? l Competitiveness – 23% of new clinical trial notifications in Australia come from NSW – Approximately 40 -50 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

Why focus on Early Phase Clinical Trials? l 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

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.

Early Phase Clinical Trials Framework The Framework comprises two key elements: l NSW Health appointed specialist early phase clinical trial Human Research Ethics Committees l Voluntary quality recognition scheme for early phase clinical trial sites and investigators in NSW

NSW Health appointed specialist early phase clinical trials HRECs l 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

Voluntary quality recognition scheme l 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

Clinical trials: OHMR initiatives l 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

Clinical trials: OHMR initiatives l 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 CHe. Re. L; collections hosted in the new Biobank facility will have data linkage for follow up data

Key messages This Framework will: l 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 l Give participants and host institutions assurance that early phase trials are as safe as possible l 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 l 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 l Potential for scale up to all clinical trials if successfully implemented

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 Email General enquiries Tim Mackay 9391 9228 ohmr@doh. health. nsw. gov. au Early Phase Clinical Trials Framework Christine Whittall 9461 7069 trgs@doh. health. nsw. gov. au Biobanking and data Brett Reed linkage 9391 9362 breed@doh. health. nsw. gov. au Ethics and Governance 9391 9920 researchethics@doh. health. nsw. gov. au James Cokayne