Statistical considerations

♦ State the basis of the sample size calculation in sufficient detail that it could be reproduced by those reading the protocol (see Section 5.3).

♦ State the number of patients required, the significance level, and the power.

♦ Indicate over what period it is expected to complete the intake.

♦ List the responsibilities of the independent data monitoring and ethics committee, and how often it is expected that they will meet to review interim analyses.

Planned analyses should be described in sufficient detail that a statistician new to the trial can clearly see the general approach intended. It is important to outline how any 'non-standard' data, such as quality of life data, are to be analysed. It maybe useful to state the details of analysis in a separate analysis protocol which could be made available on request.

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