05.08 · Cours 8 — Essais cliniques, exemples

Course 8 — Clinical trials, examples

Course and questions · 46 pages

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Clinical Trials: Case Studies

1Clinical Trials: Case Studies

Review: Randomized Clinical Trial

2PICO Question 3Randomization 4Blinding 5Placebo, Concealment, ITT

6Course Objectives

Case 1: Dexamethasone & Pharyngitis

7Overview 8Trial Design (JAMA 2017)9Primary & Secondary Results 10Baseline Comparison 11Why No Baseline Statistical Test 12Measures of Association 13Risk Difference & Relative Risk 1424h Result Interpretation 15Confidence Interval Interpretation 16P-value & Type 2 Error 1748h Secondary Outcome

Case 2: Scurvy in Sailors

18Lind's 1747 Experiment 19Delayed Impact of Results 20Lessons & Limitations

Case 3: Streptomycin & Tuberculosis

211948 BMJ Trial Design 22Results & P-value Misinterpretation 23Contributions & Remaining Gaps

Case 4: Myocardial Infarction (ISIS-2)

24Mechanism & Treatments 25Factorial Trial Design 26Main Result: 35-Day Mortality 27Lancet Subgroup Pressure 28Zodiac Subgroup & Type 1 Error 29Lessons from ISIS-2

Case 5: Coronary Drug Project

30Trial Design & Adherence 31Adherence Bias Trap 32Lessons: ITT & Placebo

Case 6: Hydroxychloroquine & COVID-19

33In Vitro Evidence (2005)34Marseille Non-Randomized Study 35Media & Policy Before Evidence 36RECOVERY Trial Design 37RECOVERY Timeline 38RECOVERY Randomization Schema 39HCQ Ineffective (RECOVERY)40Dexamethasone Effective (RECOVERY)41Dexamethasone Stratified by Severity 42Average Effect & Subgroup Heterogeneity 43RECOVERY Results Summary

44General Messages 45Next Lecture: Diagnostic Tests 46Closing

05.08Page 1Clinical Trials: Case Studies

Cours 8 — Essais cliniques, exemples page 1

05.08Page 2Clinical Trials: Case StudiesReview: Randomized Clinical TrialPICO Question

Cours 8 — Essais cliniques, exemples page 2

05.08Page 3Clinical Trials: Case StudiesReview: Randomized Clinical TrialRandomization

Cours 8 — Essais cliniques, exemples page 3

05.08Page 4Clinical Trials: Case StudiesReview: Randomized Clinical TrialBlinding

Cours 8 — Essais cliniques, exemples page 4

05.08Page 5Clinical Trials: Case StudiesReview: Randomized Clinical TrialPlacebo, Concealment, ITT

Cours 8 — Essais cliniques, exemples page 5

05.08Page 6Clinical Trials: Case StudiesCourse Objectives

Cours 8 — Essais cliniques, exemples page 6

05.08Page 7Clinical Trials: Case StudiesCase 1: Dexamethasone & PharyngitisOverview

Cours 8 — Essais cliniques, exemples page 7

05.08Page 8Clinical Trials: Case StudiesCase 1: Dexamethasone & PharyngitisTrial Design (JAMA 2017)

Cours 8 — Essais cliniques, exemples page 8

05.08Page 9Clinical Trials: Case StudiesCase 1: Dexamethasone & PharyngitisPrimary & Secondary Results

Cours 8 — Essais cliniques, exemples page 9

05.08Page 10Clinical Trials: Case StudiesCase 1: Dexamethasone & PharyngitisBaseline Comparison

Cours 8 — Essais cliniques, exemples page 10

05.08Page 11Clinical Trials: Case StudiesCase 1: Dexamethasone & PharyngitisWhy No Baseline Statistical Test

Cours 8 — Essais cliniques, exemples page 11

05.08Page 12Clinical Trials: Case StudiesCase 1: Dexamethasone & PharyngitisMeasures of Association

Cours 8 — Essais cliniques, exemples page 12

05.08Page 13Clinical Trials: Case StudiesCase 1: Dexamethasone & PharyngitisRisk Difference & Relative Risk

Cours 8 — Essais cliniques, exemples page 13

05.08Page 14Clinical Trials: Case StudiesCase 1: Dexamethasone & Pharyngitis24h Result Interpretation

Cours 8 — Essais cliniques, exemples page 14

05.08Page 15Clinical Trials: Case StudiesCase 1: Dexamethasone & PharyngitisConfidence Interval Interpretation

Cours 8 — Essais cliniques, exemples page 15

05.08Page 16Clinical Trials: Case StudiesCase 1: Dexamethasone & PharyngitisP-value & Type 2 Error

Cours 8 — Essais cliniques, exemples page 16

05.08Page 17Clinical Trials: Case StudiesCase 1: Dexamethasone & Pharyngitis48h Secondary Outcome

Cours 8 — Essais cliniques, exemples page 17

05.08Page 18Clinical Trials: Case StudiesCase 2: Scurvy in SailorsLind's 1747 Experiment

Cours 8 — Essais cliniques, exemples page 18

05.08Page 19Clinical Trials: Case StudiesCase 2: Scurvy in SailorsDelayed Impact of Results

Cours 8 — Essais cliniques, exemples page 19

05.08Page 20Clinical Trials: Case StudiesCase 2: Scurvy in SailorsLessons & Limitations

Cours 8 — Essais cliniques, exemples page 20

05.08Page 21Clinical Trials: Case StudiesCase 3: Streptomycin & Tuberculosis1948 BMJ Trial Design

Cours 8 — Essais cliniques, exemples page 21

05.08Page 22Clinical Trials: Case StudiesCase 3: Streptomycin & TuberculosisResults & P-value Misinterpretation

Cours 8 — Essais cliniques, exemples page 22

05.08Page 23Clinical Trials: Case StudiesCase 3: Streptomycin & TuberculosisContributions & Remaining Gaps

Cours 8 — Essais cliniques, exemples page 23

05.08Page 24Clinical Trials: Case StudiesCase 4: Myocardial Infarction (ISIS-2)Mechanism & Treatments

Cours 8 — Essais cliniques, exemples page 24

05.08Page 25Clinical Trials: Case StudiesCase 4: Myocardial Infarction (ISIS-2)Factorial Trial Design

Cours 8 — Essais cliniques, exemples page 25

05.08Page 26Clinical Trials: Case StudiesCase 4: Myocardial Infarction (ISIS-2)Main Result: 35-Day Mortality

Cours 8 — Essais cliniques, exemples page 26

05.08Page 27Clinical Trials: Case StudiesCase 4: Myocardial Infarction (ISIS-2)Lancet Subgroup Pressure

Cours 8 — Essais cliniques, exemples page 27

05.08Page 28Clinical Trials: Case StudiesCase 4: Myocardial Infarction (ISIS-2)Zodiac Subgroup & Type 1 Error

Cours 8 — Essais cliniques, exemples page 28

05.08Page 29Clinical Trials: Case StudiesCase 4: Myocardial Infarction (ISIS-2)Lessons from ISIS-2

Cours 8 — Essais cliniques, exemples page 29

05.08Page 30Clinical Trials: Case StudiesCase 5: Coronary Drug ProjectTrial Design & Adherence

Cours 8 — Essais cliniques, exemples page 30

05.08Page 31Clinical Trials: Case StudiesCase 5: Coronary Drug ProjectAdherence Bias Trap

Cours 8 — Essais cliniques, exemples page 31

05.08Page 32Clinical Trials: Case StudiesCase 5: Coronary Drug ProjectLessons: ITT & Placebo

Cours 8 — Essais cliniques, exemples page 32

05.08Page 33Clinical Trials: Case StudiesCase 6: Hydroxychloroquine & COVID-19In Vitro Evidence (2005)

Cours 8 — Essais cliniques, exemples page 33

05.08Page 34Clinical Trials: Case StudiesCase 6: Hydroxychloroquine & COVID-19Marseille Non-Randomized Study

Cours 8 — Essais cliniques, exemples page 34

05.08Page 35Clinical Trials: Case StudiesCase 6: Hydroxychloroquine & COVID-19Media & Policy Before Evidence

Cours 8 — Essais cliniques, exemples page 35

05.08Page 36Clinical Trials: Case StudiesCase 6: Hydroxychloroquine & COVID-19RECOVERY Trial Design

Cours 8 — Essais cliniques, exemples page 36

05.08Page 37Clinical Trials: Case StudiesCase 6: Hydroxychloroquine & COVID-19RECOVERY Timeline

Cours 8 — Essais cliniques, exemples page 37

05.08Page 38Clinical Trials: Case StudiesCase 6: Hydroxychloroquine & COVID-19RECOVERY Randomization Schema

Cours 8 — Essais cliniques, exemples page 38

05.08Page 39Clinical Trials: Case StudiesCase 6: Hydroxychloroquine & COVID-19HCQ Ineffective (RECOVERY)

Cours 8 — Essais cliniques, exemples page 39

05.08Page 40Clinical Trials: Case StudiesCase 6: Hydroxychloroquine & COVID-19Dexamethasone Effective (RECOVERY)

Cours 8 — Essais cliniques, exemples page 40

05.08Page 41Clinical Trials: Case StudiesCase 6: Hydroxychloroquine & COVID-19Dexamethasone Stratified by Severity

Cours 8 — Essais cliniques, exemples page 41

05.08Page 42Clinical Trials: Case StudiesCase 6: Hydroxychloroquine & COVID-19Average Effect & Subgroup Heterogeneity

Cours 8 — Essais cliniques, exemples page 42

05.08Page 43Clinical Trials: Case StudiesCase 6: Hydroxychloroquine & COVID-19RECOVERY Results Summary

Cours 8 — Essais cliniques, exemples page 43

05.08Page 44Clinical Trials: Case StudiesGeneral Messages

Cours 8 — Essais cliniques, exemples page 44

05.08Page 45Clinical Trials: Case StudiesNext Lecture: Diagnostic Tests

Cours 8 — Essais cliniques, exemples page 45

05.08Page 46Clinical Trials: Case StudiesClosing

Cours 8 — Essais cliniques, exemples page 46