Embedding Clinical Trials in Healthcare

Reduce the cost and shorten the duration of clinical trials by integrating clinical trial processes as a routine and integrated component of the healthcare system.

  • Define embedding of clinical trials within routine healthcare delivery
  • Describe and report examples of successful embedding
  • Develop a comprehensive model of embedding
  • Identify enablers and barriers to successful embedding
  • Create a community of practice among trialists who utilise embedding
  • Develop and implement a strategy to remove barriers and promote enablers including elements related to the design and conduct of trials, the healthcare system and public policy
  • Develop metrics that evaluate embedding

Recent group activities

  • Consensus definition of embedding clinical trials in healthcare
  • International Best Practice Towards a Learning Healthcare System: A scoping activity to map international approaches to embedding clinical trials into the healthcare system
  • Embedding Research in Routine Care: Health Service Provider Consultation Report: national consultation with health service providers from large, research-active healthcare institutions around Australia regarding embedding research into routine health service delivery
  • Clinical Trials Governance Framework: Working Group assisting ACTA complete response to the Commission during public consultation phase of the national project
  • Member of the national GP round table consultation
  • Presented works at NHMRC and ACTA Summit

Current group activities

  • Exemplars Project: Consultation with clinical trialists, including those who have achieved embedded trials, to understand barriers and enablers of embedding

Future group activities

The group is creating a comparative effectiveness clinical trial model in which they will evaluate national policies (such as NHMRC National Statement and Privacy Act) to define a pathway for comparative effectiveness trials to be deemed low or negligible-risk, and a step-by-step guide to determine if a trial meets these criteria. This model will define comparative effectiveness research and the standard of evidence required to demonstrate this status and associated guidance document for researchers.

They’re developing a community of practice for researchers and health services that aims to achieve embedding and developing a practical guide to assist researchers and institutions to better embed clinical trial activities as part of routine practice.

They also plan to deliver at least one event on embedded trial design to provide expert panel feedback to optimise the design and identify potential barriers.

The group is developing consumer information for participation in low risk comparative effectiveness trials through simplified, consumer-endorsed, standard content for patient information sheets and consent forms, with accompanying guidance.

Group Leadership

  • Prof Nik Zeps
  • A/Prof Tom Briffa
  • Prof Ian Harris
  • Ms Sue Jenkins‐Marsh
  • Prof Tony Keech
  • Ms Tanya Symons
  • Dr Christopher Williams

Members

  • Mr Nic Aagaard
  • Prof Jim Buttery
  • As/ Prof Winston Cheung
  • Prof Derek Chew
  • Prof Richard Chye
  • Ms Lisa Cowan
  • Ms Annette Cubitt
  • A/Prof Joshua Davis
  • Prof Jon Emery
  • Dr Magid Fahim
  • Prof Michael Findlay
  • A/Prof Ross Haslam
  • Prof Stephen Jan
  • Dr Edward Litton
  • Ms Helen Monaghan
  • Prof Jonathan Morris
  • Prof Mark Nelson
  • Prof Alistair Nicol
  • Prof Stephen Nicholls
  • Prof Claire Rickard
  • Ms Delaine Smith
  • Prof William Tarnow‐Mordi
  • Prof Jan Tennent
  • A/Prof Evelin Tiralongo

Project Officer

Ms Nicola Straiton

Board Sponsors

  • Prof John Simes
  • Prof Vlado Perkovic