Individual skill
lancet-study-design
Use to lock study design and mandatory prospective registration for a Lancet clinical manuscript — trial registration before enrollment, protocol + statistical analysis plan, and design rigor (randomization, allocation concealment, blinding, pre-specified endpoints, power, ITT). Covers observational design choices too.
Lancet-Skills/skills/lancet-study-design/SKILL.md
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- Last checked
- Nov 9, 2026
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- Repository last updated
- Sep 27, 2026
- License
- MIT
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# Study Design & Registration (lancet-study-design)
## When to trigger
- Planning or writing up a clinical trial or a major observational study.
- The trial registration number is missing, or registration timing is unclear.
- There is no protocol or no pre-specified statistical analysis plan (SAP).
- A reviewer is likely to ask "was the primary endpoint pre-specified?" and there is no clear answer.
## Mandatory: prospective trial registration
The Lancet follows ICMJE: **clinical trials must be registered prospectively — before the first participant is enrolled — in a WHO-ICTRP primary registry or ClinicalTrials.gov.**
- [ ] Registered **before** enrollment of the first participant (retrospective registration is a serious, often fatal, problem — flag it immediately and disclose honestly).