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
- A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis: Complete Statistical AnalysisIndependent statistical analysis of A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis: primary endpoint results, effect estimate with confidence interval,…
- A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation: Complete Statistical AnalysisIndependent statistical analysis of A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies: Complete Statistical AnalysisIndependent statistical analysis of A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies: primary endpoint results, effect estimate with confidence interval, sample-size…
- A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection: Complete Statistical AnalysisIndependent statistical analysis of A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…
- A Study of Ad26.COV2.S in Adults (COVID-19): Complete Statistical AnalysisIndependent statistical analysis of A Study of Ad26.COV2.S in Adults (COVID-19): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04436276).
- A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects: Complete Statistical AnalysisIndependent statistical analysis of A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…
- A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002): Complete Statistical AnalysisIndependent statistical analysis of A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…
- A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014): Complete Statistical AnalysisIndependent statistical analysis of A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19: Complete Statistical AnalysisIndependent statistical analysis of A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…
- A Study of Auxora in Patients With Critical COVID-19 Pneumonia: Complete Statistical AnalysisIndependent statistical analysis of A Study of Auxora in Patients With Critical COVID-19 Pneumonia: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04661540).
- A Study of Belimumab in the Prevention of Kidney Transplant Rejection: Complete Statistical AnalysisIndependent statistical analysis of A Study of Belimumab in the Prevention of Kidney Transplant Rejection: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…
- A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074): Complete Statistical AnalysisIndependent statistical analysis of A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…
- A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B: Complete Statistical AnalysisIndependent statistical analysis of A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B: primary endpoint results, effect estimate with confidence…
- A Study of COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir in the Kingdom of Saudi Arabia: Complete Statistical AnalysisIndependent statistical analysis of A Study of COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir in the Kingdom of Saudi Arabia: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection: Complete Statistical AnalysisIndependent statistical analysis of A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection: primary endpoint results, effect estimate with confidence interval, sample-size planning…
- A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection: Complete Statistical AnalysisIndependent statistical analysis of A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…
- A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy: Complete Statistical AnalysisIndependent statistical analysis of A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…
- A Study of Immunogenicity and Safety of GSK Biologicals’ Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older: Complete Statistical AnalysisIndependent statistical analysis of A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older: primary endpoint results, effect estimate with confidence interval, sample-size…
- A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2): Complete Statistical AnalysisIndependent statistical analysis of A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01385566).
- A Study of Intravenous Zanamivir in the Treatment of Hospitalized Patients With Influenza Infection: Complete Statistical AnalysisIndependent statistical analysis of A Study of Intravenous Zanamivir in the Treatment of Hospitalized Patients With Influenza Infection: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…
- A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza: Complete Statistical AnalysisIndependent statistical analysis of A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers: Complete Statistical AnalysisIndependent statistical analysis of A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- A Study of JNJ-64281802 in Participants With Confirmed Dengue Fever: Complete Statistical AnalysisIndependent statistical analysis of A Study of JNJ-64281802 in Participants With Confirmed Dengue Fever: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04906980).
- A Study of LY3041658 in Adults With Hidradenitis Suppurativa: Complete Statistical AnalysisIndependent statistical analysis of A Study of LY3041658 in Adults With Hidradenitis Suppurativa: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04493502).
- A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults: Complete Statistical AnalysisIndependent statistical analysis of A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT05415462).
- A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults: Complete Statistical AnalysisIndependent statistical analysis of A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…
- A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment: Complete Statistical AnalysisIndependent statistical analysis of A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment: primary endpoint results, effect estimate with confidence…
- A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).: Complete Statistical AnalysisIndependent statistical analysis of A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).: primary endpoint results, effect estimate with confidence interval, sample-size…
- A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) – Positive Chronic Hepatitis B: Complete Statistical AnalysisIndependent statistical analysis of A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B: primary endpoint results, effect estimate with confidence interval,…
- A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD): Complete Statistical AnalysisIndependent statistical analysis of A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation: Complete Statistical AnalysisIndependent statistical analysis of A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection…
- A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016): Complete Statistical AnalysisIndependent statistical analysis of A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016): primary endpoint results, effect estimate with…
- A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027): Complete Statistical AnalysisIndependent statistical analysis of A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…
- A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248): Complete Statistical AnalysisIndependent statistical analysis of A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus…
- A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006): Complete Statistical AnalysisIndependent statistical analysis of A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…
- A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002): Complete Statistical AnalysisIndependent statistical analysis of A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002): primary endpoint results, effect estimate with confidence interval, sample-size…
- A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006): Complete Statistical AnalysisIndependent statistical analysis of A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006): primary endpoint results, effect estimate with…
- A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C: Complete Statistical AnalysisIndependent statistical analysis of A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C: primary endpoint results, effect estimate…
- A Study on the Immune Response and Safety of a Vaccine Against Herpes Zoster in Adults Aged 50 Years and Older in India: Complete Statistical AnalysisIndependent statistical analysis of A Study on the Immune Response and Safety of a Vaccine Against Herpes Zoster in Adults Aged 50 Years and Older in India: primary endpoint results, effect estimate…
- A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine: Complete Statistical AnalysisIndependent statistical analysis of A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or…
- A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older: Complete Statistical AnalysisIndependent statistical analysis of A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years…
- A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects: Complete Statistical AnalysisIndependent statistical analysis of A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…
- A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, With Matrix-M1 Adjuvant: Complete Statistical AnalysisIndependent statistical analysis of A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, With Matrix-M1 Adjuvant: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…
- A Study to Compare Tenofovir DF Versus the Combination of Emtricitabine Plus Tenofovir DF for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase (ALT): Complete Statistical AnalysisIndependent statistical analysis of A Study to Compare Tenofovir DF Versus the Combination of Emtricitabine Plus Tenofovir DF for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase (ALT):…
- A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India: Complete Statistical AnalysisIndependent statistical analysis of A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India: primary endpoint results, effect estimate with…
- A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection: Complete Statistical AnalysisIndependent statistical analysis of A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection: primary endpoint results, effect estimate with confidence interval, sample-size planning…
- A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals’ Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences)…
- A Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT05677256).
- A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…
- A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules:…