Description
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Secondary & Post-Hoc Analysis Manuscripts
GPP3-aligned secondary publication development for subgroup analyses, exploratory endpoints, and post-hoc investigations. Transparent communication of additional clinical trial insights.
Compliance Framework
- GPP3 – Secondary publication guidance
- ICMJE – Authorship and transparent reporting
- CONSORT Extension – Harms, PROs, abstracts
- STROBE – Observational component reporting
Analysis Types
- Pre-specified subgroup analyses
- Post-hoc exploratory analyses
- Pooled/integrated efficacy analyses
- Pooled safety analyses
- Long-term extension data
- Patient-reported outcome (PRO) analyses
- Biomarker correlation studies
- Health economic analyses
Transparency Requirements
- Clear designation as post-hoc/exploratory
- Multiplicity acknowledgment
- Hypothesis-generating language
- Primary publication cross-reference
Timeline
Standard: 8-12 weeks | Complexity dependent
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