IMPACT Network Trial Endorsement

IMPACT Network Endorsed Trials

Trial Endorsement Criteria

1. Multicentre collaborative trials are preferred, although single-centre trials may be endorsed.
2. Trials should address an issue that is of major importance in which there is a recognised knowledge gap.
3. Trials should accord with the IMPACT Network’s vision and values statements and conform to these Terms of Reference and all other relevant IMPACT Network policies.
4. The IMPACT Network will only endorse trials prospectively, that is before they commence recruitment.
5. Successful competitive funding will not guarantee endorsement and it is strongly encouraged for trials to gain endorsement before submission of major funding.
6. Trial proposals should be developed in accordance with ICP, GCP or similar guidelines and should include:
1. Trial steering committee and administering institution(s).
2. A detailed protocol including a hypothesis, rationale and study aim(s)/objective(s).
3. Evidence of feasibility including proposed budget, funding strategy, and / or a demonstration of in-principle support from sites.
4. Consideration of all relevant ethical issues.
5. An intent to register the trial on a clinical trials registry.
7. The trial steering committee should include at least one member who has experience in completing a multicentre collaborative study.
8. To be eligible for endorsement, new and revised trial proposals must be presented at a minimum of one IMPACT Network meeting; presentation at an early stage of development is strongly encouraged.
9. To be eligible for endorsement inclusion of an appropriate consumer group should be demonstrated as should how their feedback has been incorporated into the trial design.
10. Where there is a known deadline for obtaining IMPACT Network endorsement of a trial proposal (such as for major grant submissions), applications should be submitted allowing sufficient time for review and revision if recommended.
11. Endorsement applications can be built around a grant application or a trial protocol or both but must provide a detailed rationale and research plan for the study, described above.
12. The trial may be conducted in association with one or more collaborating institutions. If collaboration has been formed at the time of submission for endorsement, these arrangements must be disclosed.
13. There must be a budget impact analysis that shows the expected impact of the study on the health care budget in terms of the prevalence of disease in Australia/NZ, the number of interventions and the health care costs that are involved.
14. The endorsement application must contain a systematic review of previously performed research as well as a search of appropriate trial registers.

IMPACT Network Endorsed trials will include the IMPACT Network in the authorship line of manuscripts or presentations i.e. “on behalf of the IMPACT Clinical Trials Network for Mothers’ and Babies’ Health”.

IMPACT Network Endorsed Trials will have free access to and are encouraged to use the IMPACT Network website. This will provide five trial specific pages that can be used as the main trial website and as a public repository for trial related documents.