AGITG Clinical Research Centre

Drawing upon our more than 30 years of knowledge and experience, we are pleased to open the AGITG Clinical Research Centre.
The research we conduct focuses on finding better treatments for people with GI cancer, with the aim to increase their chances of survival and improve their quality of life.

Trial development and impact

The AGITG Clinical Research Centre provides development and central coordination services to support the conduct of trials sponsored by AGITG and led exclusively by our dedicated members.

With a focus on the translation of clinical trials into practice, we work with members and our expert scientific committees to design and deliver trials that will guarantee quality, compliance and financial sustainability.

With an aim to improve cancer care and equitable access to trials for all Australians, we utilise the following strategies:

  • E-consent to enable easier participant onboarding to a trial, including video animation to simplify complex information.
  • Travel support for all study participants, including those in metropolitan areas to cover parking, taxi or other transport or petrol, to reduce the financial burden of attending hospital visits.
  • Travel support for regional, rural and remote participants, by way of payment for transport and accommodation to attend hospital visits.
  • Implementation of teletrials to reduce barriers and enable equity in clinical trial participation regardless of geographical location, delivered closer to home.

Members are encouraged to submit and develop their concepts through the AGITG Research Development and Prioritisation Framework. Trials that align with our Research Strategy and are suitable for conduct through the Clinical Research Centre will be identified during this process.

Central coordination services

Our aim is that members experience:

  • Easier participation in clinical trials as a Study Chair or Chief Principal Investigator,
  • Efficient start-up processes to enable patient access to trials,
  • Expert research development support in grant writing, protocol development and feasibility assessments,
  • Seamless navigation of budget development, contracts, ethics, regulatory and site governance processes,
  • Robust recruitment, data collection and monitoring to ensure data integrity,
  • Assurance of quality systems and processes throughout the lifecycle of the study,
  • Compliance with GCP, ethics, governance and regulatory requirements,
  • Broad access to international collaborations, and
  • Access to qualified and experienced, ICH GCP certificated clinical trial professionals.

Our central coordination services include:

Development

  • Study budget development, contract negotiation with funders and/or collaborators to access drug supply
  • Grant application development, submission and reporting as Administering Institution

Start-up

  • Project planning and management
  • AGITG Community Advisory Panel input into the concept and participant facing materials
  • Contract management with stakeholders and reporting
  • Development of all essential documents, including Protocol, Participant Information and Consent, Standard Operating Procedures, Study Manuals and Plans
  • Vendor management for drug supply and biological specimens
  • Ethics, Regulatory and Governance Process Management
  • Development and implementation of quality-driven processes for clinical trial conduct from pre-activation to archiving, including a Trial Master File
  • Development of the electronic Case Report Form and/or Safety database
  • Statistical support
  • Investigator meeting
  • Site training, initiation and activation
  • Access to no-fault compensation, indemnity and clinical trial liability insurance
  • Sponsor oversight, governance and reporting

Recruitment and maintenance

  • Medical monitoring, pharmacovigilance and safety reporting to regulatory authorities and funders
  • Remote, risk-based and onsite monitoring and reporting of deviations to relevant parties
  • Site management
  • Data management
  • Oversight by the Trial Management Committee, Research Operations Committee and the Scientific Advisory Committee

Close out

  • Data cleaning
  • Archiving
  • Development of a Clinical Study Report, publications, trial results lay summary
  • Conduct of translational research and other value-adding substudies following study closure

Trial portfolio

In 2024, we will be opening three trials for recruitment coordinated by the Centre:

  • STOPNET: A neuroendocrine tumour trial led by Dr Matthew Burge in collaboration with CommNETs and CCTG.
  • PemOla: An international pancreatic cancer trial led in Australia by Dr Dan Croagh, in conjunction with Cambridge University Hospital.
  • Neo-POLEM: A colorectal cancer trial led Prof Tim Price, in conjunction with the University of Southampton.

We would like to thank the AGITG members who have supported this effort and thank our collaborative and industry partners for their commitment to our new service offering.


Learn more

Speak to our project team at research@gicancer.org.au to learn more about how to conduct research with the AGITG Clinical Research Centre.

 

Quick links:

Submit an idea to a Working Party

View member funding opportunities

Become an AGITG member

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