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Australasian Kidney Australasian Kidney Trials NetworkTrials Network
Couran Cove March 8 2005
Aim of the NetworkAim of the Network
To design, conduct & support high quality clinical trials in kidney disease, focused on appropriate patient-centred outcomes
Main focus: investigator-initiated
BackgroundBackground
• 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
Objectives (1) 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
Objectives (2) 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
SCOPESCOPE
• 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
Advisory Board
Scientific Committee Operations Secretariat
Research Proposals
• ANZSN / TSANZ /ANZPNA
• KHA
• ANZ Dialysis & Transplant Registry
• CARI Guidelines Working Groups
• Cochrane Centre
• Pharmaceutical Companies
Scientific Committee Trial 1
Scientific Committee Trial 3
Scientific Committee Trial 2
Safety and Data
Monitoring Committee
Key Groups in the NetworkKey Groups in the Network
• Operations Secretariat
• Scientific Committee
• Advisory Board
Network – Important AspectsNetwork – Important Aspects
• Inclusive of researchers in Australia & New Zealand Sound governance structure
• Maximise use of existing structures –CARI, Cochrane, ANZDATA
Operations SecretariatOperations 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
OSOS
• Carmel Hawley (Chair)
• Manager: Ms. Elaine Beller
• Executive Officer : Mr. Daniel Francis
• Wendy Hoy
• David Johnson
• Steven McTaggart
• Zhiqiang Wang
• David Nicol
Scientific Committee - RolesScientific 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
Scientific CommitteeScientific 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
Scientific CommitteeScientific Committee
• Nephrologists – expert in clinical trials
(12)
• Indigenous doctor
• Primary care physician
• Member of RSA
Inaugural Chair: Alan CASS
SCSC• 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)
Advisory Board - RolesAdvisory 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
Advisory Board - MembershipAdvisory Board - MembershipMember 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
TrialsTrials
• 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
Publication PolicyPublication Policy
• For coordinated trials – authorship based on contribution
• For “endorsed” trials – AKTN just acknowledged – not part of authorship
How many trials can AKT How many trials can AKT run at one time?run at one time?
Depends on success with funding
• 1 large trial
• 2 smaller trials
What’s in it for you (1)What’s in it for you (1)
Opportunity to be involved with investigator initiated multicentre trials that answer questions relevant to our patients
What’s in it for you (2)What’s 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
What’s in it for you (3)What’s 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
What’s in it for you (4)What’s in it for you (4)
Opportunities to further train in clinical trial design
How can you get involvedHow 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
How do IHow do I
• Become a member?
• Submit an idea for consideration?
• Find out what is happening?
Intellectual propertyIntellectual property
• Registration of concept
• Role in management committee of trial
• Authorship
Process of trial developmentProcess of trial development
Idea/ Concept
Preliminary Trial
Proposal
Supported by network
Full Trial Protocol
Submission
Accepted by network
Trial commenced
Trial completed
CONCEPT PHASE
DEVELOPMENT PHASE
INITIATION PHASE
Phases of trial development
Funding
1.Coordinated – full process
2. Endorsed – Preliminary proposal & full protocol submission
PrioritiesPriorities
• Novelty
• Feasibility
• Clinical significance / burden of disease
Communication Communication
• Web based
Where are we up toWhere are we up to
• Funding
• Web development
• Processes & Procedures
• Trial proposals
Australasian Kidney Trials Network
• » Home
• » Welcome
• » Trial Proposal
• » Organisation Structure
• » Policies and Procedures
• » Projects, Publications and Presentations
• » Members Section
• » Forms
• » Links
• » Contact Details
• » Sitemap
Home » Welcome
Welcome Print version
Welcome to the website of the Australasian Kidney Trials (AKT) Network. We are excited about the potential of the AKT Network to facilitate clinical trials in kidney disease in Australia and New Zealand, and the impact that this may have on improving the treatment of kidney disease.
On this website you will find information about the aims, background, activites and processes of the network. We would also encourage you to consider becoming involved in the network. You can contribute by
(1) Becoming a member of the AKT Network
(2) Submitting proposals as an individual or as part of a group
Aims and Background
www.aktn.org.au
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