Clinical trials

Clinical trials are studies that explore the impact of new or existing approaches to health care. Given the valuable insights that they offer, they are an important component of a ‘self-improving healthcare system’.

The National Clinical Trials Governance Framework

The Australian Commission on Safety and Quality in Health Care (the Commission) has finalised the draft National Clinical Trials Governance Framework (Governance Framework) following national consultation. Development of the Governance Framework is underpinned by a literature review and mapping exercise of national regulation and legislation and jurisdictional legislation, polices and processes with which clinical trials must comply.

The Governance Framework, Literature Review and Mapping Exercise Report

In November 2019, all Australian Health Ministers agreed for the Commission to undertake a pilot on the Governance Framework in health service organisations currently accredited to the National Safety and Quality Health Service (NSQHS) Standards that conduct clinical trials. The pilot will be undertaken from March to May 2020.

The actions within the Governance Framework align with Standards 1 and 2 of the NSQHS Standards which are currently in place in all public and private hospitals and day procedure services. The purpose of the pilot is to ensure:

  • Health service organisations conducting clinical trials understand the intent of the Governance Framework (Standards 1 and 2)
  • The Governance Framework enables health service organisations to identify and address gaps in safety and quality of clinical trial service provision
  • The structure, sequence and format of the Governance Framework is logical and easily understood
  • The language on the intent of the Governance Framework is specific and clear
  • The Governance Framework can be implemented by health service organisations providing clinical trials and assessed for compliance to the actions within NSQHS Standards 1 and 2
  • Identification of additional resources that may be required to support national implementation of the Governance Framework.

Register your interest

Click the link and complete the required information to register your interest to participate in the pilot. You may indicate if your health service organisation is interested in providing feedback on the Governance Framework, supporting tools and resources (Level 1) or participating in the pilot as one of the 12 pilot sites (Level 2).

National Clinical Trials Governance Framework pilot - Expression of Interest survey link

Expressions of interest must be lodged no later than 13 March 2020.

Successful applicants will be notified by the Commission.

Level 1 and Level 2 pilot site responsibilities

Level 1 pilot site responsibilities

Health service organisations interested in participating in Level 1 of the pilot, will provide voluntary feedback via an on-line survey on the Governance Framework and the supporting tools and resources including: the self-assessment tool, operational metrics tool, communication materials and fact sheets.

Level 2 pilot site responsibilities

Health service organisations wishing to participate as level 2 pilot sites will have obtained agreement from their hospital administrator (or their delegate) prior to completing the on-line EOI survey. Key requirements of the health service organisations participating in level 2 of the pilot include:

  • Complete a self-assessment of current systems and processes. This process will include identification of sources of evidence available to demonstrate actions
  • Receive facilitated mentoring to assist health service organisations assess their capacity to meet the actions within the NSQHS Standards as provided in the Governance Framework and determine what needs to be in place to ensure the actions are met
  • have been met and identification of areas where actions are not met and where improvements are required
  • Submit data on trial operations via the operational metrics tool
  • Provide cost estimates on implementing the Governance Framework in your health service organisation
  • Respond to the electronic survey
  • Participate in an onsite assessment conducted by an accrediting agency
  • Participate in a post-pilot workshop with other pilot sites.

How to participate in the National Clinical Trials Governance Framework pilot.

Watch this video to understand what accreditation to the Governance Framework means for the clinical trials workforce

You can find further information on the Governance Framework on the fact sheets page.

These fact sheets explain the National Safety and Quality Health Service Standard 1: Clinical Governance Standard and 2: Partnering with Consumers Standard and identify the roles and functions of the governing body, managers (clinical and non-clinical), principal investigators, clinical trials workforce, accrediting agencies and consumers.

Background

The Commission has been engaged by the Australian Government Department of Health (the Department) on behalf of the states and territories to deliver the Governance Framework.

The project stems from recognition by all Health Ministers that, while states and territories have worked to improve the environment for clinical trials, issues of fragmentation and inefficiency remain that impact on Australia’s attractiveness as a preferred location for clinical trials.

The Governance Framework aligns with the Commission’s existing National Safety and Quality Health Service (NSQHS) Standards (second edition) for hospital accreditation and the National Model Clinical Governance Framework 

The actions within the Governance Framework align with the actions in Standards 1 and 2 of the NSQHS Standards which are already embedded in all public and private hospitals and day procedure services. 

Embedding clinical trial services into routine practices of health service organisations under the NSQHS Standards will deliver measurable operational efficiencies across multiple therapeutic areas delivering clinical trial services. These include optimising organisational strategic planning to deliver clinical trial services and more efficient trial operations such as:

  • Pre-trial assessment of a trial site (trial site selection, feasibility assessment)
  • Pre-recruitment activities (ethical and local site specific assessment review and approval time frames)
  • Recruitment activities and trial management
  • Workforce training and engagement
  • Trial related business and financial management.

This approach:

  • Strengthens governance arrangements for clinical trial services 
  • Provides clarity to those responsible for delivering clinical trials, including governments, health services, hospital administrators, clinicians, trial sponsors and patients 
  • Reduces duplication and increases efficiency, cohesion and productivity across the clinical trials sector. 

Throughout February and March 2019 national consultation on the draft Governance Framework was undertaken through a series of 12 workshops held in Sydney, Brisbane, Townsville, Melbourne, Adelaide and Perth and, via video conference with participants in the Northern Territory. Written submissions were also invited and more than 41 written submissions were received.

The Commission has finalised the Governance Framework following consultation. In November 2019, COAG Health Council agreed for the Commission to pilot the  Governance Framework in a number of hospitals/day procedure units throughout 2020. In-sights gained from the pilot will inform the approach to implementation of the Governance Framework in 2021.

What is a Clinical Trial?

Clinical trials provide early access to innovative treatments and interventions for patients, and improve the overall standard of medical care provided in Australian hospitals through the uptake of evidence into practice.  Data suggest that improved outcomes for patients participating in clinical trials are due in part to the increased clinical surveillance a trial provides and greater clinician adherence with evidence-based care. 

A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.[1] Clinical trials include but are not limited to:

  • Surgical and medical treatments and procedures
  • Experimental drugs and diagnostics[2]
  • Biological products
  • Medical devices
  • Health-related service changes
  • Health-related preventative strategies
  • Health-related educational interventions

All trials undergo rigorous evaluation to make sure that the intervention being tested is effective, safe and feasible for use more broadly in the community. 

Clinical trials generate evidence to inform best-practice ways of providing care and treatment to patients. A thriving clinical trials environment is essential for a robust and self-improving healthcare system.

[1] World Health Organisation  http://www.who.int/topics/clinical_trials/en/
[2] In the Australian context, this includes novel treatments and interventions

Self–improving health system

Self-Improving Health System

 

What is clinical trial governance? 

Governance is the set of relationships and functions established by a health service organisation or trial service between its state or territory department of health, governing body, executive, workforce, patients, consumers, and other stakeholders to ensure good clinical trial service provision.

Clinical trial service governance is an integrated component of the corporate and clinical governance of health service organisations and trial sites. It ensures that everyone, including frontline trial investigators undertaking clinical trials and members of governing bodies such as Boards, is accountable to patients and the community for assuring the delivery of clinical trials is of high quality, integrated into clinical care and continuously improving.

Economic evaluation of investigator-led clinical trials

In 2016, the Commission engaged the Australian Clinical Trials Alliance, in partnership with Quantium Health Outcomes, to evaluate the overall health and economic impact of investigator-initiated clinical trials conducted by networks.

Governments are increasingly looking to foster greater coordination and integration between safety and quality and research activities to build self-improving models of health care. As a result, there is a growing need to determine appropriate strategies to support high-quality public-good clinical trials as an integral part of the healthcare quality, safety and value agendas in Australia.

This project was intended to support evidence-based decision-making and is closely linked to the Commission's broader strategic priorities.