Statistical methods in respiratory trials
The methods these trials rely on most, based on the statistical analyses posted to ClinicalTrials.gov, with the tutorial that explains each one.
Kaplan-Meier estimation
Time-to-event endpoints
ANCOVA
Hazard ratio
Mixed-effects model
Odds ratio
Non-inferiority trial design
Cox proportional-hazards model
All respiratory trials
33 results
- ACTT-2Independent statistical analysis of ACTT-2, the randomized phase 3 trial of remdesivir plus baricitinib versus remdesivir plus placebo in COVID-19, including time-to-recovery, ordinal-scale, and safety analyses.
- ACTT-3Independent statistical analysis of ACTT-3, the phase 3 randomized trial of remdesivir plus interferon beta-1a versus remdesivir plus placebo in COVID-19, including time-to-recovery, subgroup hazard ratios, safety, and statistical interpretation.
- AMBITIONIndependent statistical analysis of the AMBITION phase 3 trial of first-line ambrisentan and tadalafil combination therapy in pulmonary arterial hypertension, including time-to-event analysis, secondary endpoints, statistical methodology, safety, and interpretation.
- ARTEMIS-IPFIndependent statistical analysis of ARTEMIS-IPF, the randomized phase 3 trial of ambrisentan versus placebo in idiopathic pulmonary fibrosis, including its time-to-event endpoint, hazard ratio, secondary analyses, statistical methods, and interpretation.
- CAN-COVIDIndependent statistical analysis of CAN-COVID, a randomized phase 3 study of canakinumab versus placebo for cytokine release syndrome in participants with COVID-19-induced pneumonia, including its primary binary endpoint, logistic regression, odds ratio,…
- COMET-PEAKIndependent statistical analysis of COMET-PEAK, the randomized phase 2 trial evaluating second-generation sotrovimab material in non-hospitalized participants with mild to moderate COVID-19, including viral-load, pharmacokinetic, ANCOVA, ANOVA, safety, and statistical interpretation.
- COMPASS-2Independent statistical analysis of COMPASS-2, evaluating bosentan added to sildenafil versus sildenafil monotherapy in pulmonary arterial hypertension, including time-to-event, functional, biomarker, quality-of-life, and safety results.
- EINSTEIN-PEIndependent statistical analysis of EINSTEIN-PE, the randomized phase 3 trial of rivaroxaban versus enoxaparin followed by VKA in patients with acute symptomatic pulmonary embolism, including non-inferiority methodology, Cox analysis, hazard ratios, bleeding,…
- EPIC-HRIndependent statistical analysis of the EPIC-HR randomized phase 2/3 trial of PF-07321332/ritonavir versus placebo in nonhospitalized high-risk adults with COVID-19, including endpoint definitions, statistical methods, reported results, safety, and interpretation.
- FLAMEIndependent statistical analysis of the FLAME phase 3 trial of QVA149 versus LABA/ICS in COPD, including exacerbation rates, time-to-event analyses, non-inferiority methodology, safety, and statistical interpretation.
- FREEDOM-CIndependent statistical analysis of FREEDOM-C, evaluating oral treprostinil versus placebo in pulmonary arterial hypertension, including trial design, 6MWD results, secondary endpoints, post-hoc analyses, statistical methodology, and interpretation.
- FREEDOM-C2Independent statistical analysis of the FREEDOM-C2 phase 3 trial of UT-15C SR versus placebo for pulmonary arterial hypertension, including the 6-minute walk distance endpoint, non-parametric ANCOVA, secondary analyses, safety, and statistical interpretation.
- FREEDOM-EVIndependent statistical analysis of FREEDOM-EV, a randomized phase 3 trial of treprostinil diolamine versus placebo in pulmonary arterial hypertension, covering clinical worsening, 6-minute walk distance, NT-proBNP, functional class, statistical methods, and safety.
- FREEDOM-MIndependent statistical analysis of FREEDOM-M, a randomized phase 3 trial of oral treprostinil versus placebo for pulmonary arterial hypertension, including 6-minute walk distance, statistical methodology, secondary analyses, safety, and interpretation.
- GOLDEN-3Independent statistical analysis of GOLDEN-3 (NCT02347761), a randomized phase 3 trial of nebulized SUN-101 in patients with COPD, including its FEV1 endpoint, MMRM methodology, multiplicity control, confidence intervals, and reported results.
- GOLDEN-4Independent statistical analysis of GOLDEN-4, a randomized phase 3 trial of nebulized SUN-101 in patients with COPD, including its MMRM methodology, primary FEV1 results, multiplicity approach, safety data, and statistical interpretation.
- GRIPHONIndependent statistical analysis of the GRIPHON phase 3 trial of selexipag in pulmonary arterial hypertension, covering its randomized time-to-event endpoint, secondary analyses, statistical methods, confidence intervals, and interpretation.
- Hokusai-VTEA complete statistical analysis of Hokusai-VTE, the randomized phase 3 trial comparing heparin/edoxaban with heparin/warfarin for symptomatic venous thromboembolism, including non-inferiority analysis, Cox modeling, bleeding outcomes, and statistical interpretation.
- INBUILDIndependent statistical analysis of the INBUILD phase 3 trial of nintedanib in patients with progressive fibrosing interstitial lung disease, including FVC decline, longitudinal modeling, time-to-event endpoints, logistic regression, safety, and interpretation.
- ISABELA 1Independent statistical analysis of ISABELA 1 (NCT03711162), a randomized phase 3 study of GLPG1690 in idiopathic pulmonary fibrosis, including FVC decline, disease progression, hospitalization, mixed-effects models, logistic regression, Cox models, and safety.
- ISABELA 2Complete statistical analysis of the ISABELA 2 phase 3 trial of GLPG1690 in idiopathic pulmonary fibrosis, including trial design, FVC decline, disease progression, hospitalization, survival endpoints, safety, statistical methodology, and interpretation.
- MOVe-AHEADIndependent statistical analysis of the phase 3 MOVe-AHEAD trial of molnupiravir for prevention of Coronavirus Disease (COVID-19) in adults, including endpoint definitions, score-based confidence intervals, reported results, safety, and statistical interpretation.
- PATENT-1Independent statistical analysis of PATENT-1, a randomized phase 3 trial of oral riociguat in patients with pulmonary arterial hypertension, covering its 6-minute walking distance endpoint, ANCOVA, nonparametric and stratified analyses, secondary outcomes,…
- REACTComplete statistical analysis of the REACT trial (NCT01329029), evaluating roflumilast versus placebo in patients with chronic obstructive pulmonary disease treated with fixed LABA and inhaled glucocorticosteroid combinations.
- REMoxTBComplete statistical analysis of the REMoxTB phase 3 trial comparing two moxifloxacin-containing treatment-shortening regimens with a control regimen for pulmonary tuberculosis, including non-inferiority methodology, risk differences, confidence intervals, safety, and interpretation.
- RESPIRE 1Independent statistical analysis of RESPIRE 1, a randomized phase 3 trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis, including time-to-exacerbation and exacerbation-rate analyses.
- RESPIRE 2Complete statistical analysis of the RESPIRE 2 phase 3 trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis, including trial design, time-to-event endpoints, hazard ratios, confidence intervals, Wald testing, and…
- ROSEComplete statistical analysis of the ROSE phase 3 trial of early neuromuscular blockade versus no routine early neuromuscular blockade in acute respiratory distress syndrome, including trial design, the primary mortality endpoint, Wald…
- RUXCOVIDIndependent statistical analysis of the phase 3 RUXCOVID trial of ruxolitinib versus placebo in patients with COVID-19 associated cytokine storm, including the primary composite endpoint, secondary outcomes, statistical methods, safety, and interpretation.
- SERAPHINIndependent statistical analysis of SERAPHIN, the randomized phase 3 trial of macitentan in symptomatic pulmonary arterial hypertension, including time-to-event endpoints, hazard ratios, confidence intervals, log-rank testing, and interpretation.
- STARSCAPEIndependent statistical analysis of the STARSCAPE phase 3 trial of zinpentraxin alfa in idiopathic pulmonary fibrosis, including trial design, endpoints, randomized efficacy analysis, time-to-event methods, safety, limitations, and statistical interpretation.
- STELLARIndependent statistical analysis of the phase 3 STELLAR trial of sotatercept plus background PAH therapy versus placebo plus background PAH therapy in pulmonary arterial hypertension, including trial design, endpoints, nonparametric analyses, hazard…
- SURMOUNT-OSAIndependent statistical analysis of SURMOUNT-OSA, a randomized phase 3 trial of tirzepatide in participants with obstructive sleep apnea and obesity, including AHI results, ANCOVA, logistic regression, confidence intervals, and safety.