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
609 results
- Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients: Complete Statistical AnalysisIndependent statistical analysis of Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00316719).
- Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281)(COMPLETED): Complete Statistical AnalysisIndependent statistical analysis of Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281)(COMPLETED): primary endpoint results, effect estimate with confidence interval, sample-size planning…
- Adhesive Tape Placement on Patients’ Masks in the Emergency Department Increases Compliance of Proper Face Mask Use: Complete Statistical AnalysisIndependent statistical analysis of Adhesive Tape Placement on Patients' Masks in the Emergency Department Increases Compliance of Proper Face Mask Use: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…
- ADVANCEIndependent statistical analysis of the ADVANCE phase 3 trial evaluating DTG plus TAF plus FTC versus DTG plus TDF plus FTC and EFV plus TDF plus FTC in first-line HIV-1 infection treatment.
- AGATE-1Independent statistical analysis of A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and…
- AirFLO2Independent statistical analysis of AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04649775).
- Airway Limitation Study: Study In Primary Care Centers Of Chronic Bronchitis In Long-Term Cigarette Smokers Of At Least 40 Years Of Age With Symptoms Of Cough And Shortness Of Breath: Complete Statistical AnalysisIndependent statistical analysis of Airway Limitation Study: Study In Primary Care Centers Of Chronic Bronchitis In Long-Term Cigarette Smokers Of At Least 40 Years Of Age With Symptoms Of Cough And Shortness…
- ALCIndependent statistical analysis of Acetyl-L-Carnitine in the Treatment of Septic Shock: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00592488).
- Algorithm for Predicting the Unfavorable Course of Sepsis in Children: Complete Statistical AnalysisIndependent statistical analysis of Algorithm for Predicting the Unfavorable Course of Sepsis in Children: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT05908162).
- AlloHCT From Matched Unrelated Donors in Pts w/ Advanced Hematologic Malignancies & Disorders: Complete Statistical AnalysisIndependent statistical analysis of AlloHCT From Matched Unrelated Donors in Pts w/ Advanced Hematologic Malignancies & Disorders: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…
- Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia: Complete Statistical AnalysisIndependent statistical analysis of Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…
- An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis: Complete Statistical AnalysisIndependent statistical analysis of An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…
- An Efficacy and Safety Study of Itraconazole Sequential Therapy (Intravenous Injection Followed by Oral Solution) in Invasive Pulmonary Fungal Infections: Complete Statistical AnalysisIndependent statistical analysis of An Efficacy and Safety Study of Itraconazole Sequential Therapy (Intravenous Injection Followed by Oral Solution) in Invasive Pulmonary Fungal Infections: primary endpoint results, effect estimate with confidence interval,…
- An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD: Complete Statistical AnalysisIndependent statistical analysis of An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…
- An Efficacy Study of Chlorhexidine Mouthwashes: Complete Statistical AnalysisIndependent statistical analysis of An Efficacy Study of Chlorhexidine Mouthwashes: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01751178).
- An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients: Complete Statistical AnalysisIndependent statistical analysis of An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients: primary endpoint results, effect estimate with confidence interval, sample-size…
- An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge: Complete Statistical AnalysisIndependent statistical analysis of An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…
- An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection: Complete Statistical AnalysisIndependent statistical analysis of An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study: Complete Statistical AnalysisIndependent statistical analysis of An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…
- An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys: Complete Statistical AnalysisIndependent statistical analysis of An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…
- Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV: Complete Statistical AnalysisIndependent statistical analysis of Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…
- Analytical Treatment Interruption (ATI) to Assess the Immune System’s Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 703/HPTN 081 AMP Study: Complete Statistical AnalysisIndependent statistical analysis of Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 703/HPTN 081 AMP Study: primary endpoint results,…
- ANDROMEDA-SHOCKIndependent statistical analysis of the ANDROMEDA-SHOCK randomized trial comparing peripheral perfusion versus lactate targeted fluid resuscitation in septic shock, including trial design, endpoints, statistical methodology, and interpretation.
- Anidulafungin In Treatment Of Candidemia In Asian Subjects: Complete Statistical AnalysisIndependent statistical analysis of Anidulafungin In Treatment Of Candidemia In Asian Subjects: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00537329).
- Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season: Complete Statistical AnalysisIndependent statistical analysis of Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season: primary endpoint results, effect estimate with confidence interval, sample-size…
- ANRS PREVENIRAn independent statistical analysis of ANRS PREVENIR (NCT03113123), evaluating PrEP with Truvada for HIV prevention in Île-de-France, including the trial design, endpoint definition, planned statistical approach, and interpretation.
- Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS): Complete Statistical AnalysisIndependent statistical analysis of Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT03261830).
- Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26: Complete Statistical AnalysisIndependent statistical analysis of Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…
- Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukemia: Complete Statistical AnalysisIndependent statistical analysis of Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…
- APEGINIndependent statistical analysis of Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…
- APPACIndependent statistical analysis of Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01022567).
- ARISEIndependent statistical analysis of the ARISE phase 3 trial evaluating Early Goal Directed Therapy in severe sepsis, including trial design, endpoints, planned analysis, statistical methodology, and interpretation.
- ASPIREIndependent statistical analysis of the ASPIRE phase 3 trial of the dapivirine vaginal ring for prevention of HIV-1 in women, including trial design, registered endpoints, planned statistical analysis, safety, limitations, and interpretation.
- Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals’ Pandemic Influenza Vaccine (GSK1562902A) in Adults: Complete Statistical AnalysisIndependent statistical analysis of Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…
- Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule: Complete Statistical AnalysisIndependent statistical analysis of Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule: primary endpoint results, effect estimate with confidence interval, sample-size…
- Assessing PA-824 for Tuberculosis (the APT Trial): Complete Statistical AnalysisIndependent statistical analysis of Assessing PA-824 for Tuberculosis (the APT Trial): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT02256696).
- Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101): Complete Statistical AnalysisIndependent statistical analysis of Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…
- ASSUREIndependent statistical analysis of A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01102972).
- ASTCIndependent statistical analysis of Antibacterial-coated Sutures at Time of Cesarean: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT03386240).
- ASTRAL-5Independent statistical analysis of Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection: primary endpoint results,…
- AtazanavirIndependent statistical analysis of Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…
- Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents: Complete Statistical AnalysisIndependent statistical analysis of Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…
- Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection: Complete Statistical AnalysisIndependent statistical analysis of Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04339426).
- ATTACCIndependent statistical analysis of ATTACC (NCT04372589), a randomized phase 2/3 trial evaluating antithrombotic therapy with heparin in patients with COVID-19 and pneumonia, including its design, primary endpoint, planned analysis, and statistical interpretation.
- AZALEAIndependent statistical analysis of the AZALEA phase 4 randomized trial of Zithromax versus placebo in asthma exacerbations, including trial design, the diary card symptom-score endpoint, planned statistical analysis, and interpretation.
- AZI001Independent statistical analysis of Azithromycin in Bronchiolitis Obliterans Syndrome: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01009619).
- B-cell Immunity to Influenza (SLVP017)- Year 5, 2013: Complete Statistical AnalysisIndependent statistical analysis of B-cell Immunity to Influenza (SLVP017)- Year 5, 2013: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT03020537).
- Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Pneumonia and Pneumococcal Vaccine: Complete Statistical AnalysisIndependent statistical analysis of Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Pneumonia and Pneumococcal Vaccine: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…
- Balance Function in Patients Post Corona Virus Disease 2019 (COVID-19): Complete Statistical AnalysisIndependent statistical analysis of Balance Function in Patients Post Corona Virus Disease 2019 (COVID-19): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04914364).
- BARI-COVIDAn independent statistical analysis of the BARI-COVID phase 2/3 study of baricitinib in symptomatic patients infected by COVID-19, including its crossover design, ICU-transfer endpoint, planned analysis, and statistical interpretation.