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Endorsed Study Model

Endorsed Study Model

Since 1991, the AGITG has been developing and conducting practice-changing research in GI cancers. In 2019, the scope of our research was expanded with the launch of the Endorsed Study Model.

This Model supports the development of pilot trials sponsored and conducted by other institutions, with the aim of developing data to support large-scale AGITG-led studies.

Benefits of the Endorsed Study Model

The AGITG will liaise with the sponsoring institution to:

  • Conduct feasibility to gauge interest from a wide network of potential sites to participate in the study;
  • Advertise the study on the AGITG website;
  • Promote the study to AGITG members;
  • Invite presentations at the ASM; and
  • CAP review and feedback: lay summary of concept and master Participant Information Sheet and Consent Form.

Current AGITG Endorsed Studies

  • RENO: Led by Prof Chris Karapetis – a prospective study of ‘Watch and Wait’ strategy in rectal cancer patients.
  • NEO-CREATE: Led by Dr Amitesh Roy – assessing the safety of adding the immunotherapy drug avelumab to chemo-radiation before surgery in patients with cancers of the oesophagus or the gastro-oesophageal junction.
  • ALT-TRACC: Led by Dr Vanessa Wong – determining the efficacy of alternating oxaliplatin and irinotecan doublet schedules versus continuous doublet chemotherapy in previously untreated metastatic colorectal cancer.
  • LICPIC: Led by A/Prof Stephen Smith – assessing if giving local anaesthetic, Lignocaine, into your bloodstream during surgery will improve part of your immune system after surgery for colorectal cancer.
  • GENESCREEN 5-FU: Led by Prof Stephen Ackland – aims to identify patients who are deficient in an enzyme known as DPD, to allow for safer chemotherapy dosing decisions.
  • EXERTION: Led by Dr Jasmine Yee – aims to develop an exercise intervention delivered during chemotherapy infusion for colon cancer.
  • ICEMELT: Led by Prof Golo Ahlenstiel – aims to investigate and prevent the development of undesirable treatment related side effects in cancer patients treated with immunotherapy.
  • SOCRATES: Led by Prof Alan Wigg – aims to evaluate the efficacy of Stereotactic body radiotherapy (SBRT) compared to standard of care for the treatment of inoperable, early stage HCC.

View all open Endorsed Studies

“I anticipate that our study will guide clinical practice and I hope that findings will lead to a clinical meaningful improvement in patient outcomes. On behalf of all the investigators involved with the RENO study, I sincerely thank the AGITG.” – Prof Chris Karapetis, RENO Study Chair

Governance Framework

The AGITG encourages investigators to submit concepts requiring ‘endorsement’ or ‘sponsorship’ for consideration. Investigators requesting AGITG endorsement of concepts must agree to the following governance framework:

  1. AGITG governance for endorsement:
    1. AGITG Working Party reviews and approves the scientific merit of the research proposal.
    2. AGITG Consumer Advisory Panel reviews and approves the relevance of the concept from a consumer perspective.
    3. AGITG reviews the site payments allocated to conduct the study.
  2. A Trial Management Committee (TMC) is appointed to maintain oversight.
  3. An AGITG Member is an Investigator on the study.
  4. Reporting study updates to AGITG:
    1. The Working Party and Scientific Advisory Committee may request study updates throughout study duration.
    2. TMC and Data and Safety Monitoring Committee meeting minutes will be shared with the AGITG.
    3. The Institution will prepare and submit monthly progress reports in alignment with current AGITG practice, using the AGITG reporting template.
    4. Trial newsletters circulated to participating sites will be shared with AGITG.
  5. If the pilot research develops a positive signal that warrants a larger-scale study, AGITG will have the expectation to review and act as Sponsor of the study.
    1. The Project Leader and AGITG will work together to source additional grant or industry funding.
    2. A Coordinating Centre selected by the AGITG will coordinate the large-scale study.
    3. AGITG will request access to the pilot study data for the purposes of developing a larger-scale study.
  6. AGITG will be acknowledged in all publications arising from the pilot study to reflect the support provided to the Project Leader.

 


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Contact

For more information on the Endorsed Study Model contact Nisha Berthon-Jones, AGITG Clinical Research Manager.

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  • Home
  • About
    • About Us
      • Chair’s Message
      • Board of Directors
      • Staff Members
      • Governance
      • Employment Opportunities
      • Our impact
      • Annual Reports
      • Scientific Advisory Committee
      • Community Advisory Panel
      • International Development Committee
      • Translational Research Committee
      • New Zealand Committee
      • Research Operations Committee
      • Upper GI and Lower GI Working Parties
      • Corporate Support
  • GI Cancer
    • What is GI cancer?
      • Oesophageal Cancer
      • Liver Cancer
      • Stomach Cancer
      • Gallbladder & Biliary Tract Cancer
      • Pancreatic Cancer
      • Gastro-Intestinal Stromal Tumour (GIST)
      • Neuroendocrine Tumours (NETs)
      • Colorectal Cancer
      • Rectal Cancer
      • Small Bowel Cancer
      • Anal Cancer
    • Resources
      • Videos
      • Webinars
      • Cancer FAQ
      • Support Groups
      • Recommended Reading
      • Information Booklets
      • Recipes
      • Helpful Links
      • Newsletter Sign-up
    • News
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    • Engage
      • Community Forums
  • Trials & Research
    • Clinical Trials
      • Trial Recruitment
      • Concepts – In Development
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      • Trials – Endorsed Studies
      • Participating Trial Centres
      • Clinical Trial FAQs
      • Genesis of a Clinical Trial
    • Research
      • Developing our Research
      • Research Priorities
      • Upper GI and Lower GI Working Parties
      • Idea Generation Workshop
      • Endorsed Study Model
      • Translational Research
      • Translational Research Model
      • Tele-Trial Model
      • Publications and Presentations
  • Health Professionals
    • AGITG
      • Become a Member
      • Member Spotlight
      • Our impact
      • Funding
    • Awards and Grants
      • Innovation Grant
      • Rectal Cancer Research Grant
      • Philanthropic Funding
      • Merck-AGITG Clinical Research Fellowship in GI Cancer
      • New Concepts Symposium
      • Best of Posters & Fast Forward
      • Outstanding Site Award
      • John Zalcberg OAM Award
      • Christine Aiken Memorial Award for Excellence in AGITG Study Coordination
      • AGITG Member Fundraiser of the Year Award
      • Grant Opportunities
      • Early Career Research Award for Excellence in AGITG Research
    • CommNETs
      • Presentations & Publications
      • Projects & Working Groups
      • Newsletters
      • Annual Research Workshop
      • CommNETs Committees
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      • Policies
      • Contacts
    • News
      • Events & Education
        • Annual Scientific Meeting
  • ASM
  • Get Involved
    • The Gutsy Challenge
      • 2023 Gutsy Challenge Adventures
      • Blue Mountains Gutsy Challenge 2023
      • Mt Himlung Himal Ascent – Nepal 2021
      • Past Gutsy Challenge Adventures
    • Fundraise
      • Start a Gutsy Fundraiser
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      • Raise Your Fork for Research
      • Create Your Own Event
      • Workplace Fundraising Ideas
    • Donate
      • Where Does My Gift Go?
      • Make a Single Gift
      • Give a Monthly Gift
      • Direct Deposit Donation
      • A Gift In Your Will
      • Give In Memory
      • Workplace Giving
    • Volunteer
      • Corporate Support
  • Contact

GI Cancer Icon Changing outcomes for people with GIgastro-intestinal cancer since 1991

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