Please structure your outline proposal using the headings listed below, where applicable.
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3.1 |
What is the proposed trial design?
E.g. double blind RCT, case control study |
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3.2 |
What are the planned trial interventions?
Both experimental and control. |
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3.3 |
What are the proposed practical arrangements for allocating participants to trial groups?
E.g. randomisation method. If stratification or minimisation are to be used, give reasons and factors to be included. |
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3.4 |
What are the proposed methods for protecting against other sources of bias?
E.g. blinding or masking. If blinding is not possible please explain why and give details of alternative methods proposed or implications for interpretation of the trial results. |
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3.5 |
What are the planned inclusion/exclusion criteria? |
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3.6 |
What is the proposed duration of treatment period? |
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3.7 |
What is the proposed frequency and duration of follow up? |
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3.8 |
What are the proposed outcome measures?
Primary:
Secondary: |
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3.9 |
How will the outcome measures be measured at follow-up? |
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3.10 |
What is the proposed sample size?
Include both control and treatment groups, a brief description of the power calculations detailing the outcome measures on which these have been based, and give event rates, means and medians, etc., as appropriate. What is the justification for the size of difference that the trial is powered to detect? Does the sample size calculation take into account the anticipated rates of non-compliance and loss to follow-up given below – 3.12 and 3.13? |
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3.11 |
What is the planned recruitment rate?
How will recruitment be organised? Over what time period will recruitment take place? What evidence is there that the planned recruitment rate is achievable? |
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3.12 |
Are there likely to be any problems with compliance?
On what evidence are the compliance figures based? |
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3.13 |
What is the likely rate of loss to follow-up?
On what evidence is the loss to follow-up rate based? |
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3.14 |
Give details of the planned analyses |
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3.15 |
Are there any planned subgroup analyses? |
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3.16 |
What is the proposed frequency of analyses?
(Including any interim analyses). |
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3.17 |
Will the trial address any economic issues?
(This is not a requirement. However, please justify inclusion/exclusion of health economics and give details of any study proposed.) |
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3.18 |
What is the estimated research cost of the trial? |
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3.19 |
Will there be NHS cost implications for this trial?
You do not need to estimate the NHS costs at the outline stage. |
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3.20 |
Over what period is funding requested? |
These outline headings are based on those used by the Medical Research Council as part of their submission process.
