Australasian Kidney Trials Network

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Australasian Kidney Trials Network

• Couran Cove March 8 2005

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Aim of the Network

• To design, conduct support high quality
  clinical trials in kidney disease, focused on
  appropriate patient-centred outcomes
• Main focus investigator-initiated

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Background

• KHA and ANZSN called for EOI final applications
  to run such a network
• Brisbane Secretariat - joined with the
  Sydney based group
• (Scientific Committee)
• NHMRC Enabling grant - trials network through
  the 1st phase result May 05

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Objectives (1)

• Develop a vibrant Strategic Kidney Research
  Network for Australia, New Zealand, South East
  Asia
• Develop infrastructure for clinical trials
• Build consensus within the renal community to
  develop targeted research strategies
• Expert development of proposals for trials
  defined as priorities by the membership
• Assist network trials in contesting competitive
  funding

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Objectives (2)

• Implement training and career development
  initiatives for young nephrologists
• Focus on patient-centred outcomes with a
  practical application in priority areas
• Facilitate the recruitment of patients into
  trials deemed important to the nephrological
  community
• Promote the translation of research into clinical
  practice

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SCOPE

• clinical trials in both paediatric and adult
  populations
• secondary prevention trials in high risk
  populations such as those with diabetes,
  indigenous groups, and those with proteinuria
• trials in patients with end-stage kidney disease,
  in particular the renal dialysis and renal
  transplant populations
• primary prevention trials particularly aimed at
  indigenous communities
• trials in patients with acute renal failure

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Key Groups in the Network

• Operations Secretariat
• Scientific Committee
• Advisory Board

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Network Important Aspects

• Inclusive of researchers in Australia New
  Zealand Sound governance structure
• Maximise use of existing structures CARI,
  Cochrane, ANZDATA

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Operations Secretariat

• House the infra-structure for day-to day running
  of the network (The Engine Room of the
  organisation)
• Be based in Brisbane co-located with the clinical
  trials centre

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OS

• Carmel Hawley (Chair)
• Manager Ms. Elaine Beller
• Executive Officer Mr. Daniel Francis
• Wendy Hoy
• David Johnson
• Steven McTaggart
• Zhiqiang Wang
• David Nicol

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Scientific Committee - Roles

• Provides scientific leadership
• Provide peer review of proposals
• Prioritise protocols
• Vote on individual trials
• Select members of individual trial scientific
  committees trial management committees

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Scientific Committee

• Appointment Process
• 2 year terms that can be extended twice
• Initially rotation will be established, a third
  of members retiring every 2 years
• Members will be eligible for reappointment after
  a gap of 4 years

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Scientific Committee

• Nephrologists expert in clinical trials
• (12)
• Indigenous doctor
• Primary care physician
• Member of RSA
• Inaugural Chair Alan CASS

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SC

• Alan Cass (Chair)
• Jonathon Craig
• Stephen McDonald
• Vlado Perkovic
• Steven Chadban
• Peter Kerr
• Sharon Dogra
• Helen Pilmore
• Kevan Polkinghorne
• Gavin Becker / Rowan Walker
• Dr. Alex Brown (Indigenous doctor)
• Dr. Beres Wenck (Primary Care)

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Advisory Board - Roles

• Assess the overall management of the network
• Financial
• Organisational competence
• Strategic direction
• Overall performance - productivity would meet
  formally twice a year
• Advocacy role
• Responsible for developing performance measures
  by which to assess the performance of AKT

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Advisory Board - Membership

• Member from each of
• Nephrologist (Chair) Inaugural Chair David
  Harris
• Consumer
• Expert in clinical trial management
• Expert in financial management
• Expert in statistics and epidemiology
• This group would meet formally twice a year

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Trials

• Coordinated (80) - utilise network resources to
  develop run the trial data generally managed
  centrally
• Endorsed (20) assist in some aspects of the
  trial AKT will not run or manage the data
  usually trial design statistical advice

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Publication Policy

• For coordinated trials authorship based on
  contribution
• For endorsed trials AKTN just acknowledged
  not part of authorship

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How many trials can AKT run at one time?

• Depends on success with funding
• 1 large trial
• 2 smaller trials

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Whats in it for you (1)

• Opportunity to be involved with investigator
  initiated multicentre trials that answer
  questions relevant to our patients

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Whats in it for you (2)

• For trials you submit
• For coordinated trials , data management
  coordination will be done centrally
• Trial proposer involvement in specific trial
  scientific/management committee

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Whats in it for you (3)

• Can present trials for endorsement allowing
• (1) trial design biostatistical advice
• (2) help obtain funding by demonstrating
  endorsement
• (3) allow access to collaborators

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Whats in it for you (4)

• Opportunities to further train in clinical trial
  design

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How can you get involved

• Become a member
• Join a trial once initiated
• Submit your idea intellectual property
  protected
• Opportunity to be members of scientific committee
  ½ members to rotate SC chosen on clinical
  trials expertise
• Join an individual trial committee

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How do I

• Become a member?
• Submit an idea for consideration?
• Find out what is happening?

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Intellectual property

• Registration of concept
• Role in management committee of trial
• Authorship

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Process of trial development
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1.Coordinated full process 2. Endorsed
Preliminary proposal full protocol submission
Funding
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Priorities

• Novelty
• Feasibility
• Clinical significance / burden of disease

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Communication

• Web based
• Email

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Where are we up to

• Funding
• Web development
• Processes Procedures
• Trial proposals

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www.aktn.org.au
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