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ARCS Summit Round Up - Stream 'A' - Clinical Research Breakfast Bites Series

ARCS Summit - Stream 'A' Round Up

Clinical Research Breakfast Bites Series

A1. The role of the Clinical Trials Governance Framework – update on the pilot program and the implementation of the culture of GCP

First session of the ARCS Summit and we’re hearing about: “The role of the Clinical Trials Governance Framework”.


The National Clinical Trials Governance Framework

was developed, in conjunction with a range of stakeholders, by the Australian Commission on Safety and Quality in Health Care.

The objective is to have a nationally consistent approach

to the accreditation of health services for the conduct of clinical trials.

On 1st September 2020

a pilot of the Governance Framework started and will go to to March 2021 in 14 sites with 30 health service organisations.

The objective is to provide opportunities for strategic planning for clinical trial service provision

via systems and processes currently in place including organisational leadership, policies and procedures, risk management; incident management and open disclosure; workforce safety and quality training and infrastructure for clinical services.

This will deliver measurable operational efficiencies

reported via an operational metrics web-based tool, and assessed by quality standards.

Fiona Loughlan
Dr Bernadette Aliprandi-Costa
Ben Laverty

A2. What is the Department of Health doing - an update and discussion on

recent changes and developments

COVID has been the catalyst for a range of innovative projects in Clinical Research. Day 2 of the ARCS Summit and Session A2 is an “Update on national projects to improve the local clinical trial landscape”.


Allyson Essex

started by highlighting that “The National Cabinet sees Clinical Research as a high priority area, and will encourage a simpler and easier governance process”.

National consistency,

whilst maintaining local environmental requirements, is a key objective.

All Australian Governments

want to make it easier to start up and run clinical trials, with the aim of positioning Australia as a global leader.

The development of the Clinical Trials Governance Framework

is a step towards a nationally consistent accreditation system for trial sites.


has resulted in the increase in digitisation in Clinical Research (especially tele-trials).


has played a key role in fast-tracking COVID research.

A Parliamentary Inquiry submission

has made recommendations for making Australia a more attractive place for clinical trials.

Daniel Grant
Carrie Bloomfield
Christopher Brook
Allyson Essex
Shanny Dyer

A3. The ARCS signature course

Further key insights from industry leaders were presented at the beginning of Day 3 of the ARCS Summit in session A3.

  • Feel comfortable dealing with change

  • Undertake personal leadership development

  • Embrace the impact of technological advances

  • Seek out cross-sectional and cross-functional experiences

  • Develop curiosity

  • Looking after yourself (eg energy for performance); be conscious of how you ‘show up’ every day

  • The ability to lead in a crisis

  • Critical thinking

  • Problem solving skills

  • Understanding the science (STEM backgrounds)

  • Taking an ‘enterprise’ view and understanding the broader organisation and industry

  • Data evaluation skills

  • Empathy

  • Influence for positive outcome

  • Take risks to undertake opportunities

  • Build networks to challenge and assist you in your leadership journey

The ARCS signature course

has been developed to build customised leadership expertise for the sector; and to position people for senior roles.

Gavin Fox-Smith
Kylie Bromley
Ian Adams
Rosamund Christie

A4. COVID-19 – from pandemic to the new research normal through policy and standards (part1)

COVID has changed the Clinical Research landscape…for ever, and with many benefits. Thursday morning and Day 4 of the ARCS Summit and topic A4 is “COVID-19 – from pandemic to the new research normal through policy and standards”.



has created the opportunity to do things differently, especially around policy and procedures.

Previously there was resistance

to initiatives and the pandemic has allowed us to push ahead.

All the States have been working collaboratively

and quickly to work on a national statement to provide guidance to sites and industry.


have been discussed for some time, and the pandemic has fast-tracked its adoption, especially to support regional, rural and remote areas (with a government grant of $125 mil-lion over 5 years).

Other COVID related advances

include E-signatures; E-consents; Remote monitoring, National Tele-trials SOPs.


are that Australia will be a highly sought after location for trials in the coming year as northern hemisphere countries contend with a high second wave of infections.

Antonio Penna
Melissa Hagan
Suzanne Hasthorpe
Daniela Caiazza
David Lloyd

A5. COVID-19 pandemic – building resilience and sustainability in Australia (part 2)

Day 5 What are the important Clinical Research issues being addressed during COVID? Hear from industry leaders discuss: “COVID-19 pandemic – building resilience and sustainability in Australia”

Industry has played a pivotal in responding to the COVID pandemic and has been involved in a range of initiatives including:
  • The Medicines Shortages Working Group

  • Collaborating with local and international regulators to discuss supply chain issues

  • Involvement with industry associations to prepare industry responses to the pandemic

  • Crisis management and business continuity initiatives

Industry has been active in local vaccine trials -

has ensured that local manufacturing continues to supply critical medicines; has managed risk in clinical trials; & has ensured continuity of care.

COVID has brought great change

that would otherwise have taken years to be implemented. Collaboration, and the building of trust, across industry has increased, and the challenge is how this can be harnessed in the future.

The innovations developed

will position Australia as a preferred place to undertake clinical research.

Ian Adams
Megan Ford
Susie Nilsson
Anne Woollett