1. Clinical Trial Proposal Presentation Template for open forum at the 2017 ASM

2. Title
Investigators and sites

3. Rationale
Is there a high quality systematic review that indicates this is an evidence gap?
Are there any published or ongoing similar trials (and if so, explain why another trial is needed)?

4. Aims and study design What is the research question?
Specify the PICO (population, intervention, control, outcomes)
Specify the study design 25

5. Participants
Exclusion criteria
Inclusion criteria 36

6. Interventions
Control group
Active group 36

7. Outcome measurement Include who will perform assessments
Baseline measures
Timing of follow up
Outcome measures (include scale, MICD) 54

8. Sample size and data analysis
Include the primary endpoint and when it will be measured
Include the basis for the sample size calculation
Include the analysis plan
106

9. Feasibility
Comment on the trial feasibility and whether or not you think pilot data are needed
Is the trial feasible (reflecting cost, logistics, track record and likely recruitment rate)?
106

10. Implementation
If the trial indicates a clinical practice or other change is desirable, are there any possible barriers to implementation?
Does the trial have the potential to change practice and/or policy?
106

11. CONSIDER THESE ANZMUSC ENDORSEMENT CRITERIA
Does the research question concern an important disease burden and/or an important evidence or evidence-practice gap?
What is the evidence that the research question is one that the clinical and/or consumer community need answered?
Does answering the research question have strong potential to change practice and/or policy (reflecting academic impact, implementation, and generalisability)?
106

12. CONSIDER THESE ANZMUSC ENDORSEMENT CRITERIA
Are the methods of high quality and does the proposal include an economic evaluation and process measures where relevant?
Is the trial multicentre (to encourage collaboration, increase power and increase implementation of findings)?
106