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nejm-study-design

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Use to confirm study-design rigor and the mandatory prospective trial registration, protocol, and statistical analysis plan before writing up a clinical study for NEJM. Surfaces registration problems early — they cannot be fixed retroactively.

When to use

• confirming prospective trial registration
• verifying protocol and statistical analysis plan
• stating design rigor for Methods
• naming and justifying observational study design
• checking randomization and blinding
• verifying primary endpoint alignment
• assessing sample size and power
• identifying protocol or SAP deviations

When not to use

• writing up an unregistered trial as an Original Article without flagging
• presenting a post-hoc analysis plan as pre-specified
• reporting a primary outcome that differs from the registered one without disclosure
• treating per-protocol as the primary analysis for a superiority trial

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