December 3, 2025Open Access

Facing Methodological Regression: External Validity Failure in Large-Scale Medical Cohorts and the Case of Spurious Cancer Signals in COVID-19 Vaccine Surveillance

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Analysis reveals selection bias may inflate cancer risk signals in vaccinated populations, highlighting flaws in cohort design.

Cancer risk signals observed post-vaccination indicate significant external validity issues.
The analysis identified invalid cancer risk signals due to selection bias and flawed cohort construction.
Using statistical decomposition, internal validity was shown, but external validity was critically compromised.
Reinvigorating biostatistical rigor is essential to prevent misinformation and chaos in public health.

Roccetti, Marco (2025) studied this question.

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