Clinical / Efficacy Study Data Extraction

Study Overview

The one-look roll-up - study title and identifier, type/design, body site tested, product category, and whether the report is preliminary or final - so a reviewer can orient before reading detail.

Study Design & Methodology

The design that determines how much weight the results carry - control/comparator type, blinding and randomization, enrolled and completed panel size, demographics, duration, measurement timepoints, application regimen, and test conditions.

Test Products & Treatment Codes

Every test material and comparator with its blinded treatment code, batch/lot, and role (test / benchmark / vehicle-placebo / untreated / baseline); a swapped code invalidates the whole read-out.

Efficacy Endpoints & Instruments

Each endpoint the study measured and how - parameter, method/instrument (TEWL, corneometry, cutometry, profilometry, gravimetric sweat, grading), assessment type, timepoints, and whether it is primary or secondary.

Statistical Method Summary

The statistical approach - test(s) used, significance threshold (alpha, default 0.05), tail, multiplicity adjustment, analysis population, and software - so significance is judged consistently.

Endpoint Results vs Baseline

Within-treatment results vs baseline (T0) per treatment x endpoint x timepoint - mean, change and percent change vs baseline, standard error, p-value, and a significance flag - the effect the product produced on its own.

Between-Treatment Comparison

Head-to-head comparisons (test vs vehicle/control/benchmark) per comparison x endpoint x timepoint - difference, standard error, t-value, DF, p-value, and significance - the basis for comparative and superiority claims.

Overall Efficacy Significance

The single call on the primary endpoint - significant efficacy demonstrated, directional trend only, no significant effect, or inconclusive - read from the vs-baseline and between-treatment results against the study's alpha.

Claim Support Assessment

The evidence chain - each proposed claim tied to a specific endpoint, comparison basis, and p-value, rated Fully / Conditionally / Not supported per claim-substantiation best practice.

Claims Substantiated

The go/no-go gate - true only when at least one primary efficacy claim is backed by a statistically significant result on the appropriate comparison basis.

Protocol & Ethics Compliance

The protocol and ethics footprint that makes the study defensible - protocol/SOP and guideline followed, ethics/IRB review, informed consent, adverse events, and any GCP / data-integrity statement.

Data Integrity Validation

The consistency checks an analyst runs before trusting the read-out - completers <= enrolled, significance flags match p-values, percent change ties to the means, claims tie to significant results, timepoints agree, and sample size is adequate - each Pass / Fail / Review.

Study Findings Summary

The analyst narrative - design and panel, the key significant findings and their magnitude on the correct basis, the overall call and whether any claim is substantiated, and any integrity flags to resolve before relying on the study.