Australasian Kidney Trials Network Couran Cove March 8 2005

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

• Email

Where are we up toWhere are we up to

• Funding

• Web development

• Processes & Procedures

• Trial proposals

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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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