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
Cochran-Mantel-Haenszel test
ANCOVA
Hazard ratio
Score-based CI for proportions (Miettinen-Nurminen, Newcombe, Wilson)
Fisher exact test
Odds ratio
All infectious disease trials
903 results
- Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…
- Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT05011513).
- Evaluation of Rapid HIV Self-testing Among MSM (eSTAMP): Complete Statistical AnalysisIndependent statistical analysis of Evaluation of Rapid HIV Self-testing Among MSM (eSTAMP): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT02067039).
- Evaluation of Reactogenicity and Safety of GSK Biologicals’ Rotarix™ (Human Rotavirus Vaccine) in Infants: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…
- Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females: primary endpoint results, effect estimate with confidence interval, sample-size planning…
- Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants: primary endpoint results, effect estimate with confidence interval,…
- Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…
- Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…
- Evaluation of Systemic Exposure to VP-102 in Subjects With Molluscum Contagiosum.: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of Systemic Exposure to VP-102 in Subjects With Molluscum Contagiosum.: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…
- Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…
- Evaluation of the Antimicrobial Effectiveness of CHG/IPA: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of the Antimicrobial Effectiveness of CHG/IPA: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04035161).
- Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…
- Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…
- Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals’ HPV Vaccine in Healthy Indian Women: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…
- Evaluation of the Immunogenicity and Safety of VARIVAX™ in Healthy Russians (V210-058): Complete Statistical AnalysisIndependent statistical analysis of Evaluation of the Immunogenicity and Safety of VARIVAX™ in Healthy Russians (V210-058): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…
- Evaluation of the Implementation and Effectiveness of IPP-HPV: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of the Implementation and Effectiveness of IPP-HPV: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT02994290).
- Evaluation of the Performance and Safety of Two Intradermal Delivery Devices.: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of the Performance and Safety of Two Intradermal Delivery Devices.: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…
- Evaluation of the RD-X19 Treatment Device in Individuals With Mild COVID-19: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of the RD-X19 Treatment Device in Individuals With Mild COVID-19: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…
- Evaluation of the Safety and Immune Responses of the Towne Strain of CMV in Seronegative Women: Complete Statistical AnalysisIndependent statistical analysis of Evaluation of the Safety and Immune Responses of the Towne Strain of CMV in Seronegative Women: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- EVOGUARDIndependent statistical analysis of Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…
- EW-DIndependent statistical analysis of A Community Wellness Program for Adults Living With Long-term Physical Disability: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…
- Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia: Complete Statistical AnalysisIndependent statistical analysis of Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…
- Examining How a Text Message-based Educational Intervention Influences COVID-19 Testing: Complete Statistical AnalysisIndependent statistical analysis of Examining How a Text Message-based Educational Intervention Influences COVID-19 Testing: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT07074171).
- Experiential HIV Testing Increasing Testing Related Knowledge and Practice, and Reduce Stigma Toward HIV of Nurses.: Complete Statistical AnalysisIndependent statistical analysis of Experiential HIV Testing Increasing Testing Related Knowledge and Practice, and Reduce Stigma Toward HIV of Nurses.: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies: Complete Statistical AnalysisIndependent statistical analysis of Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies: primary endpoint results, effect estimate with confidence interval, sample-size planning…
- Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults: Complete Statistical AnalysisIndependent statistical analysis of Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…
- Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection: Complete Statistical AnalysisIndependent statistical analysis of Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection: primary endpoint results, effect estimate with confidence interval, sample-size…
- Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.: Complete Statistical AnalysisIndependent statistical analysis of Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.: primary endpoint results, effect estimate with confidence interval,…
- EXTRA-CVDIndependent statistical analysis of A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…
- Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation: Complete Statistical AnalysisIndependent statistical analysis of Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04683744).
- FACTS 001Independent statistical analysis of FACTS 001, a randomized phase 3 trial evaluating tenofovir gel for prevention of HIV-1 infection in women and effects on HSV-2 infection.
- Feasibility of SBIRT-PN: Complete Statistical AnalysisIndependent statistical analysis of Feasibility of SBIRT-PN: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT03057119).
- Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV: Complete Statistical AnalysisIndependent statistical analysis of Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…
- Feasibility Study of GlaxoSmithKline Biologicals’ GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.: Complete Statistical AnalysisIndependent statistical analysis of Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.: primary endpoint results, effect estimate with confidence interval, sample-size planning…
- Fecal Microbiota Transplantation (FMT) for MDRO UTI: Complete Statistical AnalysisIndependent statistical analysis of Fecal Microbiota Transplantation (FMT) for MDRO UTI: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT03367910).
- 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.
- Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense: Complete Statistical AnalysisIndependent statistical analysis of Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT03974178).
- First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.: Complete Statistical AnalysisIndependent statistical analysis of First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.: primary endpoint results, effect estimate with…
- First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants: Complete Statistical AnalysisIndependent statistical analysis of First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants: Complete Statistical AnalysisIndependent statistical analysis of First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight: Complete Statistical AnalysisIndependent statistical analysis of Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…
- Fluid Balance in the ICU – Interventions to Minimize Fluids in Patients With Septic Shock: Complete Statistical AnalysisIndependent statistical analysis of Fluid Balance in the ICU - Interventions to Minimize Fluids in Patients With Septic Shock: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…
- FOCUSComplete statistical analysis of the FOCUS randomized phase 3 trial comparing liberal and restrictive blood transfusion strategies in surgical patients with cardiovascular disease, including endpoint definitions, reported odds ratios and risk differences,…
- FREESIAIndependent statistical analysis of Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV): primary endpoint results, effect…
- From Innovation to Solutions: Childhood Influenza Vaccination Planning: Complete Statistical AnalysisIndependent statistical analysis of From Innovation to Solutions: Childhood Influenza Vaccination Planning: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01664793).
- FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir: Complete Statistical AnalysisIndependent statistical analysis of FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…
- Fucidin® Cream in the Treatment of Impetigo: Complete Statistical AnalysisIndependent statistical analysis of Fucidin® Cream in the Treatment of Impetigo: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00986856).
- G2YMIIndependent statistical analysis of Getting to Yes, Michigan! (G2YMI): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT05096260).
- GAINIndependent statistical analysis of Improving HIV Diagnosis, Linkage to Care, and Prevention Services With HIV Point-of-Care Nucleic Acid Tests: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…