Education: Ready, Fire, Aim

Example: Ready… Aim… FIRE!
Ready: Formulate the clinical question.
Aim: Design the right sized clinical trial to ensure you have sufficient power to test the hypotheses you are interested in.
 Conduct the trial and report the results with confidence.

Example: Ready… FIRE!… Aim…
Ready: Formulate the clinical question.
FIRE! Conduct the trial as soon as possible, don’t bother with calculating the necessary sample size. Report inconclusive, unclear, underpowered results.
Aim: Figure out the sample size you probably should have used. List the small sample size as a limitation “The small sample size meant we did not have power to detect a significant difference“. Plea for further research on the topic.

Investigators have a responsibility to ensure their trial design and corresponding analysis decisions are sound.

Journals have a responsibility not to publish poorly designed and analysed clinical trials. They should be particularly sensitive to ready, FIRE, aim methodologies (fortunately these are easy to detect).

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