Statistical methods in infectious disease trials
The methods these trials rely on most, based on the statistical analyses posted to ClinicalTrials.gov, with the tutorial that explains each one.
Non-inferiority trial design
Risk difference
Kaplan-Meier estimation
Time-to-event endpoints
Cochran-Mantel-Haenszel test
ANCOVA
Hazard ratio
Score-based CI for proportions (Miettinen-Nurminen, Newcombe, Wilson)
All infectious disease trials
36 results
- ACTG A5279Independent statistical analysis of ACTG A5279 (NCT01404312), a randomized phase 3 trial comparing a rifapentine-plus-isoniazid regimen with an isoniazid regimen for tuberculosis prevention in people with HIV.
- 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.
- Ad26.COV2.SIndependent statistical analysis of the phase 3 Ad26.COV2.S trial in healthy adults for COVID-19 prevention, including randomized design, influenza and SARS-CoV-2 immunogenicity endpoints, ANOVA, geometric mean ratios, non-inferiority, confidence intervals, and safety.
- ATLASIndependent statistical analysis of the phase 3 ATLAS trial of long-acting cabotegravir plus long-acting rilpivirine in HIV-1 infected adults, including non-inferiority design, Cochran-Mantel-Haenszel analysis, confidence intervals, and Week 48 results.
- 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,…
- CAPRISA 008Independent statistical analysis of CAPRISA 008, a randomized phase 2/3 trial evaluating 1% tenofovir gel provision through family planning services for HIV prevention, including adherence, HIV incidence, pregnancy, HPV, and safety analyses.
- CLOVERSIndependent statistical analysis of the CLOVERS phase 3 trial comparing restrictive fluids with liberal fluids in patients with septic shock, including trial design, primary mortality analysis, secondary outcomes, statistical methodology, and interpretation.
- 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.
- COVACTAIndependent statistical analysis of the randomized phase 3 COVACTA trial evaluating tocilizumab versus placebo in patients with severe COVID-19 pneumonia, including endpoint definitions, reported treatment effects, confidence intervals, p-values, and statistical methodology.
- DISCOVERIndependent statistical analysis of the DISCOVER phase 3 trial evaluating F/TAF versus F/TDF for HIV-1 pre-exposure prophylaxis, including non-inferiority testing, rate-ratio analysis, BMD, renal biomarkers, and statistical methodology.
- 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.
- FEM-PrEPIndependent statistical analysis of FEM-PrEP, a randomized phase 3 trial evaluating Truvada versus placebo for preventing HIV acquisition in women, including its time-to-event analysis, safety endpoints, secondary outcomes, and statistical interpretation.
- FLAMINGOComplete statistical analysis of the FLAMINGO phase 3 trial comparing dolutegravir with darunavir/ritonavir, each combined with dual NRTIs in ART-naive participants with HIV-1 infection.
- GS-US-236-0102Independent statistical analysis of GS-US-236-0102, a randomized phase 3 trial comparing Stribild with Atripla in antiretroviral treatment-naive adults with HIV-1 infection, including the Week 48 virologic-success endpoint, non-inferiority framework, Wald/z-test methodology, and…
- GS-US-236-0103Independent statistical analysis of GS-US-236-0103 (NCT01106586), a randomized phase 3 study comparing Stribild with ritonavir-boosted atazanavir plus Truvada in antiretroviral treatment-naive adults with HIV-1.
- GS-US-292-0104Independent statistical analysis of GS-US-292-0104 (NCT01780506), a randomized phase 3 trial comparing E/C/F/TAF with E/C/F/TDF in antiretroviral treatment-naive adults with HIV-1 infection, including its non-inferiority analysis, risk difference, confidence interval, and Cochran-Mantel-Haenszel…
- GS-US-292-0109Independent statistical analysis of GS-US-292-0109 (NCT01815736), a randomized phase 3 trial evaluating switching from a TDF-containing regimen to E/C/F/TAF in virologically suppressed HIV-1-positive participants.
- HPTN 052Independent statistical analysis of HPTN 052, a randomized phase 3 trial evaluating early versus delayed antiretroviral therapy and linked and all partner HIV infection rates.
- HPTN 083Independent statistical analysis of HPTN 083, a randomized phase 2/3 trial comparing injectable cabotegravir with TDF/FTC for HIV pre-exposure prophylaxis in HIV-uninfected men and transgender women who have sex with men.
- HVTN 505Complete statistical analysis of HVTN 505, a randomized phase 2 trial of HIV-1 DNA plasmid and recombinant adenoviral vector vaccines in HIV-uninfected participants, including trial design, endpoints, Cox survival analyses, safety, and…
- HVTN 702Independent statistical analysis of HVTN 702, a randomized phase 2/3 HIV vaccine prevention trial evaluating ALVAC-HIV and bivalent subtype C gp120/MF59 versus placebo, including time-to-event methods, hazard ratios, confidence intervals, safety, and…
- iPrExIndependent statistical analysis of the randomized phase 3 iPrEx trial of daily TDF/FTC versus placebo for HIV prevention in men, including primary efficacy and safety endpoints, secondary analyses, statistical methods, 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.
- ODINIndependent statistical analysis of the ODIN phase 3 trial comparing once-daily versus twice-daily darunavir/ritonavir in early treatment-experienced HIV-1 infected patients, including non-inferiority methodology, logistic regression, ANCOVA, Cox models, confidence intervals, and reported…
- Partners PrEPAn independent statistical analysis of the Partners PrEP phase 3 trial, examining TDF and FTC/TDF for prevention of HIV-1 acquisition in HIV-1 discordant couples, including Cox regression, hazard ratios, safety, longitudinal analyses,…
- PURPOSE 2Independent statistical analysis of PURPOSE 2, a randomized phase 3 trial of lenacapavir for HIV pre-exposure prophylaxis, including its rate-based primary analyses, Poisson regression, Wald testing, confidence intervals, and statistical interpretation.
- 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.
- 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.
- SAILINGComplete statistical analysis of the SAILING phase 3 trial comparing GSK1349572 (dolutegravir) with raltegravir in antiretroviral-experienced, integrase inhibitor-naive adults with HIV infection, including its non-inferiority design, Cochran-Mantel-Haenszel analysis, risk difference, confidence interval,…
- SALSAIndependent statistical analysis of the phase 3 SALSA trial of switching to dolutegravir/lamivudine fixed-dose combination from a current antiretroviral regimen in virologically suppressed adults with HIV-1 infection.
- SINGLEComplete statistical analysis of the SINGLE phase 3 trial comparing dolutegravir plus abacavir/lamivudine with Atripla in HIV-1 infection, including the Week 48 primary endpoint, later virologic suppression analyses, CD4 outcomes, non-inferiority methodology,…
- SPRING-2Independent statistical analysis of the SPRING-2 phase 3 trial comparing dolutegravir 50 mg once daily with raltegravir 400 mg twice daily for HIV-1 infection, including its non-inferiority design, stratified Cochran-Mantel-Haenszel analysis, confidence…
- TBTC Study 31Complete statistical analysis of TBTC Study 31, a randomized phase 3 trial of rifapentine-containing tuberculosis treatment-shortening regimens, including non-inferiority methodology, disease-free survival, safety, confidence intervals, and interpretation.
- TDF2Independent statistical analysis of the randomized TDF2 trial of tenofovir disoproxil fumarate plus emtricitabine for HIV prevention, including trial design, registered endpoints, Cox and logistic regression methods, reported results, safety, limitations, and…
- VOICEIndependent statistical analysis of the VOICE phase 2 trial of tenofovir 1% gel, oral tenofovir disoproxil fumarate, and emtricitabine/tenofovir disoproxil fumarate for prevention of HIV infection in women.