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Back to SteamcellSCE Educational LibraryStructured Educational Evidence Review · Dr. Mack Sullivan

Category 9

Clinical-Trial Evidence and Evidence Grading

10 topics planned. Each topic is published as a Professional and Patient edition only after explicit author approval.

    1. · Discovery
    2. · Proof of concept
    3. · Animal studies
    4. · Toxicology
    5. · Phase 1
    6. · Phase 2
    7. · Phase 3
    8. · Regulatory review
    9. · Postmarketing surveillance
    1. · In-vitro models
    2. · Organoids
    3. · Small-animal models
    4. · Large-animal models
    5. · Disease-model validity
    6. · Reproducibility
    7. · Translation failures
  • Approved
    1. · Randomization
    2. · Allocation concealment
    3. · Blinding
    4. · Placebo controls
    5. · Active controls
    6. · Sham procedures
    7. · Multicenter trials
    1. · Eligibility criteria
    2. · Disease severity
    3. · Prior treatment
    4. · Comorbidities
    5. · Age
    6. · Sex
    7. · Race and ethnicity
    8. · Generalizability
  • Approved
    1. · Safety endpoints
    2. · Biomarkers
    3. · Imaging
    4. · Functional outcomes
    5. · Patient-reported outcomes
    6. · Quality of life
    7. · Survival
    8. · Clinically meaningful differences
    1. · Sample size
    2. · Statistical power
    3. · Confidence intervals
    4. · Multiple comparisons
    5. · Missing data
    6. · Subgroup analysis
    7. · Intention-to-treat analysis
    1. · Selection bias
    2. · Performance bias
    3. · Detection bias
    4. · Attrition bias
    5. · Selective reporting
    6. · Sponsorship bias
    7. · Publication bias
    1. · Case reports
    2. · Case series
    3. · Observational studies
    4. · Controlled trials
    5. · Randomized trials
    6. · Systematic reviews
    7. · Meta-analyses
    8. · Guidelines
  • Approved
    1. · Certainty of evidence
    2. · Magnitude of effect
    3. · Consistency
    4. · Directness
    5. · Precision
    6. · Risk-benefit balance
    1. · Registration number
    2. · Sponsor
    3. · Study phase
    4. · Recruitment status
    5. · Primary endpoint
    6. · Results posting
    7. · IND claims
    8. · Why registration does not equal endorsement