Trial Review and Approval Process
The Network offers support to three categories of trials: co-ordinated trials, facilitated trials and endorsed trials.
To ensure that trials are developed to the high standard expected of the AKTN, ie that they are clinically relevant, that trials and trial proposers are treated fairly, and that AKTN resources are spent in the most efficient means possible, a trial review and approval process has been developed. Please refer to the flowchart below which outlines the progression of a trial concept submission through the AKTN's review and approval process.
Click to open Trial Approval Process Flowchart.
Click to open Trial Concept Submission Form.
New Trials for submission to the Scientific Committee must be submitted by the following due dates so the appropriate review processes can occur:
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Coordinated Trials
Coordinated Trials use Network resources to develop and coordinate the running of the trial. Data is generally managed centrally.
The proposal will proceed through the trial review process and will have the full resources of the Network available to develop the protocol and run the trial. In general, the data management will be done centrally and a Network biostatistician will be appointed to the trial.
A Trial Management Committee (TMC) will be formed to develop and run coordinated trials to the rigorous standards of the AKTN. Assuming the trial proposer wishes to act as the Principle Investigator, they will also be Chair of the TMC.
Please refer to the Trial Concept Review Form for Coordinated Trials.
Facilitated Trials
A facilitated trial is where the AKTN acts as the local Australian and New Zealand regional (ANZ) Sponsor of a larger, multi-national trial. All ethical and regulatory submissions are handled by the AKTN offering the following services: procurement of local funding (if required), site management, monitoring, and protocol support. Usually, database and statistical management is handled centrally (ie by the international coordinating group).
An ANZ TMC and an ANZ Steering Committee (this committee includes representatives from all participating sites) is usually formed to discuss local conduct issues, and often the Chair of the ANZ TMC (who is also the ANZ Chief Investigator) will also sit on the international TMC.
Please refer to the Trial Concept Review Form for Facilitated Trials.
Endorsed Trials
The Network will offer assistance in some aspects of the trial design but will not run the trial or manage the data. In endorsing a trial, the Network indicates its support for the aims and objectives of the trial. Typically, support will be in the form of trial design and bio-statistical advice. Please refer to the AKTN Endorsement Policy for further information about processes relating to the endorsement of proposed trials.
Through endorsement, investigators may:
- Obtain access to the potential collaborating opportunities as provided by the Network
- Receive advice as per facilitated and coordinated trials
- State that the Network has endorsed the trial in funding applications.
Requirements for Endorsed Trials:
- Trial protocols must be developed following the standards and expectations of the Australasian Kidney Trials Network.
- Investigators must seek endorsement prior to the trial commencing.
- The AKTN name may appear on funding applications only after AKTN endorsement has been given.
- Trials must comply with Network policies on ethical conduct of research.
- In publications of AKTN Endorsed trials, the AKTN should be acknowledged appropriately.
Please see AKTN Endorsement Policy.
Please refer to the Trial Concept Review Form for Endorsed Trials.