Each indication-specific claim receives both a development stage and an evidence-confidence grade.
| Grade | Meaning | Typical support |
|---|---|---|
| A | Established for a specific labeled use | Current approval plus adequate controlled trials and post-market context |
| B | Moderate human evidence | Multiple controlled studies or a strong pivotal study, but no current approval for the claim |
| C | Preliminary human evidence | Small, uncontrolled, surrogate-endpoint, or early-phase studies |
| D | Preclinical only | In vitro or animal evidence with no adequate human efficacy evidence |
| E | Anecdotal/marketing claim | Testimonials, extrapolation, or vendor claims without adequate scientific support |
| X | Evidence contradicts or does not support the claim | Adequate negative evidence, failed program, or claim inconsistent with the studied material |
The grade applies to a precise claim, not to the molecule as a whole. An approved drug may have grade A evidence for one indication and grade D or E evidence for an off-label claim.
Study-level fields
Evidence tables record population, comparator, sample size, route, duration, endpoint, result, important limitations, and identifier. Statistical significance is not treated as clinical importance, and biomarker changes are not silently converted into patient benefit.
Common bias checks
randomization, concealment, blinding, attrition, selective reporting;
multiplicity and post-hoc analyses;
small-study and sponsor bias;
short follow-up for chronic-benefit or safety claims;
non-equivalence of the tested pharmaceutical product and a marketed "research" vial;
retractions, expressions of concern, trial termination, and regulatory rejection or withdrawal.