• SMi Source has 733 microlearning topics and 96 lessons when searching for Clinical Trials

  • Lessons

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    Drug R&D: Clinical Trial Design

    Asthma: Treatment

    Diabetes: Introduction to Clinical Trial Design

    Anticoagulation: Studies and Registries

    Schizophrenia: Treatments

    Drug R&D: Clinical Statistics in Clinical Trials

    Rheumatoid Arthritis: Treatments with Biologics

    Biotech: Basics

    Lupus: Treatments

    Oncology: Melanoma

    Stroke: Annotated Studies

    Anticoagulation: Thienopyridines

    Biotech: Monoclonal Antibodies

    HIV: Clinical Research Studies

    Rheumatoid Arthritis: Clinical Presentation and Assessment

    Oncology: Sarcoma

    Stroke: State

    Oncology: Non-Small Cell Lung Cancer

    Edoxaban

    Alzheimer's Disease: Treatment

    Diabetes: Pathology of Complications

    Oncology: Head and Neck

    Immunology: Therapeutic Immunology

    Lupus: Clinical Presentation

    Diabetes: Introduction to Incretin

    Biotech: Biologics

    Alzheimer's Disease: Biomarkers

    Drug R&D: Clinical Statistics

    Drug R&D: Combination Product Regulatory Requirements

    Atherosclerosis: Lipid Lowering Agents

    Psoriasis: Biologics

    Multiple Sclerosis

    Multiple Sclerosis: Treatments and Strategies

    Cardiovascular: Acute Coronary Syndrome

    Biotech: Protein Formulation

    Opioids: Addiction Treatment

    Myelofibrosis: Treatment

    Multiple Sclerosis: Treatment Strategies

    Cardiovascular: Platelet Biology

    Alzheimer's Disease: Therapeutic Approaches

    Rheumatoid Arthritis: Treatments with Nonbiologic DMARDS

    Biotech: Biosimilars

    Anticoagulation: Health Economics and Outcomes Research

    Cardiovascular: Cancer VTE

    Multiple Sclerosis: Diagnosis and Prognosis

    HIV: Therapeutic Regimens

    Rheumatoid Arthritis: Biologic Therapy

    Genetics: Introduction to Genetic Epidemiology

    Cardiovascular: Interventional Therapy

    Diabetes: Insulin Biosimilars

    Multiple Sclerosis: Pathogenesis and Clinical Symptomology

    Anticoagulation: Standard Anticoagulants

    Psoriasis: Treatments

    Osteoporosis: Diagnosis

    Reproduction: Hypogonadism Treatment of Males

    Pharmacokinetics: PK in Action

    Diabetes: Type 2- Pediatric Issues

    Alzheimer's Disease: Diagnostic Criteria

    Diabetes: Premixed Insulins

    Binge Eating Disorder: Current Treatment

    Biologics

    Atherosclerosis: Treatment

    Anticoagulation: Treatments I

    Atherosclerosis: Pathophysiology

    Hepatology: Treatment Landscape for Primary Biliary Cirrhosis

    Stroke

    Oncology: Metastatic Breast Cancer

    Post-traumatic Stress Disorder: Treatment

    Diabetes: Introduction to Pharmacokinetics and Pharmacodynamics

    Fetal Alcohol Spectrum Disorders: Assessing Risk

    Drug R&D: Toxicology Applications

    Opioids: Dependence and Addiction

    Binge Eating Disorder: Biological Basis

    Fetal Alcohol Spectrum Disorders: Screening

    Diabetes: Basis for Some Measures Used in Studies

    Cardiovascular: Hyperlipidemia

    Cardiovascular: Hypertension

    Oncology Primer: Immunology of Cancer

    Osteoporosis: Diagnostic and Monitoring Techniques

    Oncology: Colorectal Cancer

    Cardiovascular: Venous Thromboembolism

    Lysosomal Storage Disorders

    Nephrology: Diseases of the Kidney

    Anticoagulation: Antiplatelet Drug Therapy

    Lysosomal Storage Disorders: Hunter Syndrome

    Myelodysplastic Syndrome: Therapeutic Decisions

    Myelodysplastic Syndrome: Therapies

    Psoriasis: Clinical Picture

    Anticoagulation: Treatments II

    Obesity

    Alzheimer's Disease: Pathology

    Cardiovascular: Atrial Fibrillation

    Anticoagulation: Novel Oral Anticoagulants

    Drug R&D: Toxicology Principles

    Atherosclerosis: Heart Failure

    Immunology: Immune System Pathology

  • Microlearning Topics

  • Endpoints

    Clinical Versus Biological Endpoints

    Clinical Trials

    Different Clinical Trial Designs

    Clinical Trials: Overview

    Clinical Trials: Overview

    Conclusion

    The Need for Clinical Trials

    Clinical Trials in Drug Development

    The Purpose of Clinical Trials

    Clinical Trials in Drug Development

    The Purpose of Clinical Trials: Phases

    Clinical Trials: Post Completion

    Publications Requirements for Clinical Trials

    Dabigatran Clinical Trials: Summary

    Dabigatran Clinical Trials: Summary

    Rivaroxaban Clinical Trials: Summary

    Rivaroxaban Clinical Trials: Summary

    Apixaban Clinical Trials: Summary

    Apixaban Clinical Trials: Summary

    Drug Development Overview

    Clinical Trial

    Clinical Trials in Drug Development

    The Purpose of Clinical Trials
    The Purpose of Clinical Trials: Phases

    Clinical Trials

    Clinical Trials for Conventional Antipsychotics

    Endpoints

    Endpoints
    Primary and Secondary Endpoints
    Objective and Subjective Endpoints
    Clinical...

    Study Objectives

    Understanding Clinical Design
    Secondary Objectives
    Studies are Carefully Planned
    Clin...

    Hypotheses

    Trial Design

    Diabetes Clinical Trial Design: Randomized Controlled Trial (RCT) Designs

    Randomized Controlled Trial (RCT)

    Study Objectives

    Study Objectives: Protocol and Statistical Analysis Plan

    Study Objectives

    Secondary Objectives

    Clinical Trials: Good Clinical Practice

    Good Clinical Study Design

    Summary

    Interpreting Study Results and Properly Designed Clinical Trials

    Review of Clinical Trials and Meta-analyses of Biologic Agents

    Comparisons of Clinical Trial Results

    Study Objectives

    Understanding Clinical Design

    Study Objectives

    Clinical Plan

    Introduction

    The Use of Statistics in Clinical Trials and Scientific Hypothesis Testing

    The Role of Interim Analysis

    Trial Continuation

    Drug Discovery

    Clinical Trials

    Drug Development Overview

    Clinical Trial
    Drug Development

    Endpoints

    Endpoints

    Conclusion

    The Need for Clinical Trials
    A Well Designed Clinical Trial Can Have Pronounced Effects on Clin...

    Conclusion

    A Well Designed Clinical Trial Can Have Pronounced Effects on Clinical Practice

    Clinical Trials: Outcomes in Diabetes Trials

    Clinical Trial Outcomes

    How to Interpret Study Results?

    Clinical Relevance

    Application of Design

    Human Pharmacology (Typically in Phase I)
    Human Pharmacology (Phase I)
    Exploratory (Phase ...

    SLE Treatments: MAbs/Biologics

    Belimumab: Clinical Trials
    Belimumab: Clinical Trial 1(Phase II)
    Belimumab Clinical Trials...

    Clinical Trials: Overview

    Clinical Trial Design: Study Phases

    Clinical Trials: Minimizing Bias

    Minimizing Bias, Control or Comparator Groups, Blinding

    SLE Treatments: MAbs/Biologics

    Belimumab Clinical Trials 2 and 3: Warnings and Precautions

    Summary

    Hypotheses, Errors and Multiplicity
    Interim Analysis
    Intent-To-Treat, Per-Protocol Analysi...

    Hypotheses

    Statistical Hypothesis

    Summary

    Interim Analysis

    Conclusion

    The Need for Clinical Trials

    Hypotheses

    Alternative Hypothesis

    Hypotheses

    Proof by Contradiction

    Types of Studies

    Study Population

    The Role of Interim Analysis

    Interim Analysis
    Interactive Exercise: Adjustment Methods
    Trial Continuation

    Application of Design

    Human Pharmacology (Typically in Phase I)

    Minimizing Bias

    Blinding

    Why is it Important to Control Type I Error?

    Types of Multiplicity

    Minimizing Bias

    Minimizing Bias

    Minimizing Bias

    Multiple-Control Groups

    Study Objectives

    Classification Systems

    Hypotheses

    Statistical Tests

    Hypotheses

    Null Hypothesis

    Hypotheses

    P-Values

    Endpoints

    Primary and Secondary Endpoints

    Introduction to Diabetes Clinical Trial Design

    Conducting and Analyzing Clinical Trials

    Minimizing Bias

    Randomization

    Study Objectives

    Studies are Carefully Planned

    Hypotheses

    Significance Tests

    Foundational Clinical Trials

    Overview: Clinical Trials in Different Patient Populations

    Clinical Trials of Biologic Agents

    Introduction: Clinical Trials of Biologic Agents

    Summary

    Hypotheses, Errors and Multiplicity

    Study Objectives

    Study Objectives: Safety, Efficacy, Effectiveness, Comparison, and Outcomes

    Endpoints

    Objective and Subjective Endpoints

    Minimizing Bias

    Control Groups

    Types of Studies

    Design Types

    Background of Clinical Trials

    Clinical Trials of Biologic RA Treatments

    Clinical Trials: Statistical Analysis

    Analyzing the Results of Diabetes Trials

    SLE Treatments: MAbs/Biologics

    Belimumab Clinical Trials 2 and 3: Efficacy
    Belimumab Clinical Trials 2 and 3: Warnings and Pre...

    Dabigatran Clinical Trials: Atrial Fibrillation

    Dabigatran Clinical Trials

    Apixaban Clinical Trials: Atrial Fibrillation

    Apixaban Clinical Trials

    Rivaroxaban Clinical Trials: Atrial Fibrillation

    Rivaroxaban Clinical Trials: Overview

    Minimizing Bias

    Minimizing Bias
    Measures to Avoid Bias and Variability
    Control Groups
    Blinding
    R...

    Background

    Clinical Trials

    Foundational Clinical Trials

    Metastatic Melanoma

    Hypotheses

    Statistical Hypothesis
    Interactive Exercise: Phase 2 AMG 706 Trial
    Statistical Tests
    ...

    Prasugrel Clinical Trials

    Objectives: Testing the Hypothesis

    Foundational Clinical Trials

    Combination Chemotherapy Trials in Metastatic Melanoma: Stage IV Melanoma

    Dabigatran Clinical Trials: Venous Thromboembolism

    REMEDY and RESONATE Trials

    Development of Monoclonal Antibodies

    Clinical Trial Goals

    Prasugrel Clinical Trials

    Recurrent Events Data

    Background of Clinical Trials

    Initial studies with Monoclonal Antibodies

    Dabigatran Clinical Trials: Acute Coronary Syndrome

    REDEEM Trial

    Prasugrel Clinical Trials

    MI Analysis (Including Universal Definition)

    Rivaroxaban Clinical Trials: Venous Thromboembolism

    EINSTEIN-PE Trial

    What is the Intent to Treat Principle?

    Incomplete Data

    What is the Intent to Treat Principle?

    Protocol Violations

    What is the Intent to Treat Principle?

    Excluding Events

    How to Interpret Study Results?

    Hypothesis Testing

    Dabigatran Clinical Trials: Venous Thromboembolism

    RECOVER Trial

    Apixaban Clinical Trials: Atrial Fibrillation

    ARISTOTLE Trial

    Prasugrel Clinical Trials

    JUMBO-TIMI 26 Study

    Types of Studies

    Experimental Studies: Design Examples

    Research Study Design

    Clinical Trials

    Types of Studies

    Design Types
    Observational Studies: Cohort
    Case-Control Study
    Experimental Studies: D...

    What is the Intent to Treat Principle?

    Safety Analysis

    The Role of Interim Analysis

    Interim Analysis

    Clinical Trials: Good Clinical Practice

    Good Clinical Practice (GCP)

    Drug Development Overview

    Drug Development

    Study Objectives

    Elements of a Well-Written Study Objective

    Types of Studies

    Case-Control Study

    Types of Studies

    Reducing Assessment Variability

    Application of Design

    Human Pharmacology (Phase I)

    Application of Design

    Exploratory (Phase II)

    Application of Design

    Therapeutic Use (Phase IV)

    What is the Intent to Treat Principle?

    Imputation

    SLE Treatments: MAbs/Biologics

    Belimumab
    Belimumab: Indication
    Belimumab: Mechanism of Action
    Belimumab: Dosage and ...

    Why is it Important to Control Type I Error?

    Errors in Significance Testing
    Type I Errors: Significance Level
    Type II Errors: Power

    Minimizing Bias

    Measures to Avoid Bias and Variability

    Types of Studies

    Observational Studies: Cohort

    What is the Intent to Treat Principle?

    Incomplete Data
    Protocol Violations
    Intent-To-Treat (ITT) and Pro-Protocol (PP) Analyses

    Diagnosis of RA

    Clinical Measures - Measures used in Clinical Trials

    Clinical Trials: Minimizing Bias

    Minimizing Bias

    How Are Sample Size Calculations Made?

    Sample Size
    Interactive Exercise: Sample Size
    Sample Size Calculations

    Review of Clinical Trials and Meta-analyses of Biologic Agents

    Introduction: Review of Clinical Trials

    Clinical Trials: Patient Disposition

    Patient Disposition

    Clinical Trials: Minimizing Bias

    Randomization

    SLE Treatments: MAbs/Biologics

    Belimumab Clinical Trials 2 and 3: Trial Design

    Clinical Trials: Study Populations

    Types of Study Populations

    Clinical Trials: Cardiovascular Outcomes for Diabetes Drugs

    Common Outcomes in Diabetes Trials

    Diabetes Clinical Trial Design: Cohort Designs

    Cohort Study

    Clinical Trials: Primary and Secondary Outcomes

    Trial Design, Choosing a P Value

    Clinical Trials: Event Definitions

    Analyzing the Results of Diabetes Trials: Relative Risk

    Bone Sarcoma

    Foundational Clinical Trials: Chondrosarcoma

    How to Interpret Study Results?

    Hypothesis Testing
    Interactive Exercise: Definitive and Non-definitive Results
    Clinical Re...

    Bone Sarcoma

    Foundational Clinical Trials: Incorporating Ifosfamide

    Bone Sarcoma

    Foundational Clinical Trials: Ewing Sarcoma

    Investigational Treatment Strategies

    Investigational Clinical Trials: Immunotherapy

    Study Design: Active-Controlled Trials

    Active-Controlled Trials

    SLE Treatments: MAbs/Biologics

    Belimumab: Clinical Trials

    Foundational Clinical Trials

    Metastatic Melanoma:Darthmouth Regimen

    Prasugrel Clinical Trials

    Early and Late Events (Landmark Analysis): Study Design

    Dabigatran Clinical Trials: Atrial Fibrillation

    RELY Study

    Rivaroxaban Clinical Trials: Atrial Fibrillation

    ROCKET Atrial Fibrillation

    Soft Tissue Sarcomas (STSs)

    Foundational Clinical Trials: Interpretation of Clinical Data

    Conclusion

    FDA Approves New HRT Warning Label

    Minimizing Bias

    Accidental Bias: Randomization Fails to Balance Risk Factors

    Diagnosis of RA

    Measures Used in Clinical Trials - EULAR

    Why is it Important to Control Type I Error?

    Multiple Primary Endpoints

    Why is it Important to Control Type I Error?

    Type II Errors: Power

    How Are Sample Size Calculations Made?

    Sample Size

    Summary

    Intent-To-Treat, Per-Protocol Analysis and Sample Size

    Why is it Important to Control Type I Error?

    Errors in Significance Testing

    Diagnosis of RA

    Measures Used in Clinical Trials - ACR

    Diagnosis of RA

    Measures Used in Clinical Trials - DAS

    Application of Design

    Pivotal/Confirmatory (Typically Phase 2/3)

    How Are Sample Size Calculations Made?

    Sample Size Calculations

    Bone Sarcoma

    Foundational Clinical Trials: Osteosarcoma - Aggressive Preoperative Chemotherapy

    Diabetes Clinical Trial Design: Overview

    Different Types of Study Design for Different Purposes

    How to Interpret Study Results?

    Hypothesis Testing
    Interactive Exercise: Definitive and Non-definitive Results

    Why is it Important to Control Type I Error?

    Type I Errors: Significance Level
    Type II Errors: Power

    SLE Treatments: MAbs/Biologics

    Belimumab Clinical Trials 2 and 3: Trial Design
    Belimumab Clinical Trials 2 and 3: Study Endpo...

    Aspirin and Primary Stroke Prevention

    Clinical Trials and Meta-analysis Data

    Clinical Trials: Primary and Secondary Outcomes

    Example of a Primary Outcome: Liraglutide vs. Sitagliptin

    Investigational Treatment Strategies

    Investigational Clinical Trials: Vaccines and New Targeted Therapies

    Diabetes Clinical Trial Design: Case Control Designs

    Case Control Study

    Diabetes Clinical Trial Design: Cross-Sectional Survey Designs

    Cross-Sectional Survey

    Diabetes Clinical Trial Design: Crossover Designs

    Randomized Crossover Design

    Foundational Clinical Trials

    Metastatic Melanoma: BCT Pooled Analyses

    Investigational Treatment Strategies

    Investigational Clinical Trials: Targeting Angiogenesis

    Investigational Treatment Strategies

    Investigational Clinical Trials: Toll-Like Receptor Agonists

    Investigational Treatment Strategies

    Investigational Clinical Trials: Adoptive Cell Therapy

    Additional Treatment Options

    Targeted Therapies in Clinical Trials

    SLE Treatments: MAbs/Biologics

    Belimumab: Clinical Trial 1(Phase II)

    Review of Clinical Trials and Meta-analyses of Biologic Agents

    Biologic Treatments and Remission in Early RA

    Rivaroxaban Clinical Trials: Overview of Other Development Programs

    Development Programs: Rivaroxaban

    Research Study Design

    Clinical Trials
    Research Study Design

    Bone Sarcoma

    Foundational Clinical Trials: Osteosarcoma - Survival Rates

    Why is it Important to Control Type I Error?

    Type I Errors: Significance Level

    Investigational Treatment Strategies

    Investigational Clinical Trials

    What is the Intent to Treat Principle?

    Intent-To-Treat (ITT) and Pro-Protocol (PP) Analyses

    Diagnosis of RA

    Measures Used in Clinical Trials - Assessment of Joint Damage by X-Ray

    Soft Tissue Sarcomas (STSs)

    Foundational Clinical Trials: Summary of Foundational Studies

    Phase III Data: Hokusai-VTE

    Phase III Clinical Trials

    Soft Tissue Sarcomas (STSs)

    Foundational Clinical Trials: Limb-Sparing Surgery

    Additional Treatment Options

    Targeted Therapies in Clinical Trials: Additional Targets

    Treatment for Neuropsychiatric Symptoms in AD

    Clinical Antipsychotic Trials of Intervention Effectiveness - Alzheimers Disease (CATIE-AD)

    Introduction to Diabetes and Diabetes Terminology

    Diagnosing and Treating Diabetes

    Diabetes Clinical Trials Studying Complications

    UK Prospective Diabetes Study (UKPDS)

    Selected Basal Insulin Clinical Trials

    Insulin Glargine vs. Insulin Detemir

    Prasugrel Clinical Trials

    TRITON-TIMI 38 Clinical Trial

    Diabetes Clinical Trial Summary

    The Diabetes mellitus Insulin-Glucose infusion in Acute Myocardial Infarction 2 study (DIGAMI 2)

    Foundational Clinical Trials

    Adjuvant Therapy Trials: IFN-a

    Investigational Treatment Strategies

    Investigational Clinical Trials: Therapeutic Cancer Vaccines

    Foundational Clinical Trials

    New Targeted Therapies: Molecular Therapies in HNSCC

    Introduction to Diabetes and Diabetes Terminology

    Introduction to Diabetes and Diabetes Terminology

    Foundational Clinical Trials

    Adjuvant Therapy Trials: ECOG

    Clinical Applications of Monoclonal Antibodies

    mAbs in Clinical Trials

    Clopidogrel Clinical Trials

    PCI Studies

    Clopidogrel Clinical Trials

    PCI-CURE Study

    Clopidogrel Clinical Trials

    ISAR CHOICE Study

    Clopidogrel Clinical Trials

    CAPRIE: Conclusion

    Clopidogrel Clinical Trials

    ALBION Study

    Clopidogrel Clinical Trials

    Registration Studies

    Clopidogrel Clinical Trials

    ARMYDA-2 Study

    Clopidogrel Clinical Trials

    COMMIT Study

    Clopidogrel Clinical Trials

    CURRENT-OASIS 7: Results

    Clopidogrel Clinical Trials

    CURE Study

    Clopidogrel Clinical Trials

    CLARITY Study

    Clopidogrel Clinical Trials

    CURRENT-OASIS 7 Study

    Clopidogrel Clinical Trials

    High Loading Dose Studies

    Clopidogrel Clinical Trials

    Pretreatment Study

    Clopidogrel Clinical Trials

    PCI-CLARITY Study

    Clopidogrel Clinical Trials

    CREDO Study

    Clopidogrel Clinical Trials

    CAPRIE

    Clopidogrel Clinical Trials

    ARMYDA-2: Conclusion

    Foundational Clinical Trials

    Metastatic Melanoma

    Clopidogrel Clinical Trials

    CREDO: Conclusion

    Clopidogrel Clinical Trials

    Non-ACS (including Stroke) Studies

    Clopidogrel Clinical Trials

    CARESS Study

    Clopidogrel Clinical Trials

    CARESS: Results

    Clopidogrel Clinical Trials

    MATCH Study

    Clopidogrel Clinical Trials

    MATCH: Conclusion

    Clopidogrel Clinical Trials

    CHARISMA Study

    Clopidogrel Clinical Trials

    CHARISMA: Asymptomatic and Symptomatic

    Prasugrel Clinical Trials

    JUMBO TIMI 26: Results

    Prasugrel Clinical Trials

    Objectives: Primary Endpoints

    Prasugrel Clinical Trials

    Primary Efficacy and Safety Data

    Prasugrel Clinical Trials

    Stent Thrombosis Sub-Analysis

    Prasugrel Clinical Trials

    Stent Thrombosis Sub-Analysis: Results and Conclusion

    Prasugrel Clinical Trials

    Early and Late Events (Landmark Analysis)

    Prasugrel Clinical Trials

    Recurrent Events Data: Results and Conclusion

    Prasugrel Clinical Trials

    STEMI Population Data

    Prasugrel Clinical Trials

    STEMI Population Data: Conclusion

    Prasugrel Clinical Trials

    MI Analysis (Including Universal Definition): Results

    Prasugrel Clinical Trials

    MI Analysis (Including Universal Definition)

    Prasugrel Clinical Trials

    Diabetes Data

    Prasugrel Clinical Trials

    Diabetes Data: Conclusion

    Prasugrel Clinical Trials

    PRINCIPLE-TIMI 44 Study

    Prasugrel Clinical Trials

    PRINCIPLE-TIMI 44: Results and Conclusion

    Dabigatran Clinical Trials: Atrial Fibrillation

    RELY-ABLE Trial

    Apixaban Clinical Trials: Acute Coronary Syndrome

    APPRAISE2 Trial

    Prasugrel Clinical Trials

    Primary Efficacy and Safety Data: Net Clinical Benefit and Conclusion

    SLE Treatments: MAbs/Biologics

    Belimumab Clinical Trials 2 and 3: Trial Design

    Foundational Clinical Trials

    Combination Chemotherapy Trials in Metastatic Melanoma

    Foundational Clinical Trials

    Metastatic Melanoma: CVD Regimen

    Foundational Clinical Trials

    Metastatic Melanoma: Combination Regimens

    Foundational Clinical Trials

    Metastatic Melanoma: Biologics

    Foundational Clinical Trials

    Metastatic Melanoma: IL-2

    Dabigatran Clinical Trials: Atrial Fibrillation

    RELY: Study Population Results

    Dabigatran Clinical Trials: Atrial Fibrillation

    RELY Results: Other Outcomes

    Dabigatran Clinical Trials: Atrial Fibrillation

    RELY-ABLE

    Dabigatran Clinical Trials: Venous Thromboembolism

    RECOVER: Study Population Results

    Dabigatran Clinical Trials: Venous Thromboembolism

    RECOVER: Results Summary

    Rivaroxaban Clinical Trials: Atrial Fibrillation

    XANTUS Study

    Rivaroxaban Clinical Trials: Venous Thromboembolism

    EINSTEIN-DVT Study

    Rivaroxaban Clinical Trials: Venous Thromboembolism

    EINSTEIN-DVT: Safety Results

    Rivaroxaban Clinical Trials: Venous Thromboembolism

    EINSTEIN-PE: Safety Results

    Rivaroxaban Clinical Trials: Venous Thromboembolism

    EINSTEIN-EXT Study

    Rivaroxaban Clinical Trials: Venous Thromboembolism

    XALIA Study

    Apixaban Clinical Trials: Atrial Fibrillation

    AVERROES Study

    Apixaban Clinical Trials: Atrial Fibrillation

    ARISTOTLE: Baseline Characteristics Results

    Apixaban Clinical Trials: Atrial Fibrillation

    ARISTOTLE: Efficacy Results

    Apixaban Clinical Trials: Atrial Fibrillation

    ARISTOTLE: Safety Results

    Apixaban Clinical Trials: Atrial Fibrillation

    ARISTOTLE: Results Summary

    Apixaban Clinical Trials: Venous Thromboembolism

    AMPLIFY Study

    Apixaban Clinical Trials: Venous Thromboembolism

    AMPLIFY Study: Safety Results

    Apixaban Clinical Trials: Venous Thromboembolism

    AMPLIFY Study: Results Summary

    Apixaban Clinical Trials: Venous Thromboembolism

    AMPLIFY-EXT Study

    Dabigatran Clinical Trials: Acute Coronary Syndrome

    REDEEM Trial: D-dimer Concentrations

    Rivaroxaban Clinical Trials: Acute Coronary Syndrome

    ATLAS-ACS2 Trial

    Drug Discovery

    Drug Discovery
    Target vs. Platform-driven Discovery
    Target Validation
    Targeting Strat...

    Diagnosis of SLE

    Standard Measures of Disease Activity Used in Clinical Trials: SLAM

    Diagnosis of SLE

    Standard Measures of Disease Activity Used in Clinical Trials: ECLAM

    Diagnosis of SLE

    Standard Measures of Disease Activity Used in Clinical Trials

    Diagnosis of SLE

    Standard Measures of Disease Activity Used in Clinical Trials: SLEDAI

    Diagnosis of SLE

    Standard Measures of Disease Activity Used in Clinical Trials: SELENA-SLEDAI

    Diagnosis of SLE

    Standard Measures of Disease Activity Used in Clinical Trials: SLEDAI-2K

    Rivaroxaban Clinical Trials: Venous Thromboembolism

    EINSTEIN-DVT: Net Clinical Benefit and Summary

    Rivaroxaban Clinical Trials: Venous Thromboembolism

    EINSTEIN-PE: Net Clinical Benefit and Summary

    Selected Basal Insulin Clinical Trials

    NPH Insulin vs. Glargine Comparator Trials

    Diagnosis of SLE

    Standard Measures of Disease Activity Used in Clinical Trials: SLAM
    Standard Measures of Diseas...

    SLE Treatments: MAbs/Biologics

    Belimumab Clinical Trials 2 and 3: Efficacy

    SLE Treatments: MAbs/Biologics

    Belimumab Clinical Trials 2 and 3: Efficacy

    Diabetes Clinical Trials Studying Complications

    DCCT/EDIC Study

    Diabetes Clinical Trials Studying Complications

    DCCT/EDIC Study

    Foundational Clinical Trials

    Primary Melanoma IFN-α Adjuvant Therapy

    Foundational Clinical Trials

    Metastatic Melanoma: Single-Agent Chemotherapy

    Foundational Clinical Trials

    Metastatic Melanoma: PC Combination Regimen

    Foundational Clinical Trials

    Metastatic Melanoma: Biochemotherapy and Sequential vs. Concurrent BCT

    Foundational Clinical Trials

    Metastatic Melanoma: Biochemotherapy (BCT)

    Dabigatran Clinical Trials: Atrial Fibrillation

    RELY Results: Primary Outcome Stroke or Systemic Embolism

    Dabigatran Clinical Trials: Atrial Fibrillation

    RELY Results: Secondary Outcome Stroke

    Dabigatran Clinical Trials: Atrial Fibrillation

    RELY Results: Primary Safety Outcome Major-Bleeding, Dabigatran vs. Warfarin

    Dabigatran Clinical Trials: Venous Thromboembolism

    RECOVER: Primary and Secondary Efficacy Results

    Dabigatran Clinical Trials: Acute Coronary Syndrome

    Development Programs: RE-ALIGN Heart Valves

    Rivaroxaban Clinical Trials: Atrial Fibrillation

    ROCKET Atrial Fibrillation: Baseline Characteristics Results

    Rivaroxaban Clinical Trials: Atrial Fibrillation

    ROCKET Atrial Fibrillation: Primary Efficacy Results

    Rivaroxaban Clinical Trials: Atrial Fibrillation

    ROCKET Atrial Fibrillation: Primary Efficacy Events During Transition to Open-Label Therapy

    Rivaroxaban Clinical Trials: Atrial Fibrillation

    ROCKET Atrial Fibrillation: Secondary Efficacy Outcomes

    Rivaroxaban Clinical Trials: Atrial Fibrillation

    ROCKET Atrial Fibrillation: Results Summary

    Rivaroxaban Clinical Trials: Venous Thromboembolism

    EINSTEIN-DVT: Baseline Characteristic Results

    Rivaroxaban Clinical Trials: Venous Thromboembolism

    EINSTEIN-DVT: Primary Efficacy Results

    Rivaroxaban Clinical Trials: Venous Thromboembolism

    EINSTEIN-DVT: Primary Efficacy Results Time Course

    Rivaroxaban Clinical Trials: Venous Thromboembolism

    EINSTEIN-PE: Baseline Characteristics Results

    Rivaroxaban Clinical Trials: Venous Thromboembolism

    EINSTEIN-PE: Primary Efficacy Results

    Rivaroxaban Clinical Trials: Venous Thromboembolism

    EINSTEIN-PE: Primary Efficacy Results Time Course

    Rivaroxaban Clinical Trials: Acute Coronary Syndrome

    X-PLORER Study

    Apixaban Clinical Trials: Venous Thromboembolism

    AMPLIFY Study: Baseline Characteristics Results and Primary Efficacy Results

    Apixaban Clinical Trials: Overview of Other Development Programs

    Development Programs: Overview

    Review of Clinical Trials and Meta-analyses of Biologic Agents

    Efficacy of Biologic Agent Monotherapy in MTX-Naive Patients

    Review of Clinical Trials and Meta-analyses of Biologic Agents

    Sequential Use of TNFα inhibitors

    Review of Clinical Trials and Meta-analyses of Biologic Agents

    Sequential Use of TNFα inhibitors: Comparing Studies

    Selected Basal Insulin Clinical Trials

    Glargine vs. Standard of Care

    Selected Basal Insulin Clinical Trials

    Complex insulin regimens

    Selected Basal Insulin Clinical Trials

    DEVOTE

    Phase III Clinical Studies

    Overview of AWARD Trials 1-6

    Diagnosis of SLE

    Standard Measures of Disease Activity Used in Clinical Trials: SLEDAI-2K
    Standard Measures of D...

    Diagnosis of SLE

    Standard Measures of Disease Activity Used in Clinical Trials: SLICC/ACR Damage Index for SLE

    Diagnosis of SLE

    Standard Measures of Disease Activity Used in Clinical Trials: SLE Responder Index (SRI-4)

    Diagnosis of SLE

    Standard Measures of Disease Activity Used in Clinical Trials: BILAG, SLAM, ECLAM

    SLE Treatments: MAbs/Biologics

    Belimumab Clinical Trials 2 and 3: Study Endpoints

    Investigational Treatment Strategies

    c-Kit and HER-2, Carcinoembryonic Antigen (CEA) and Targeted Therapy Clinical Trials for HNSCC

    Review of Clinical Trials and Meta-analyses of Biologic Agents

    Efficacy of Biologic Treatment and MTX Combination Therapy in MTX-Naive Patients

    Review of Clinical Trials and Meta-analyses of Biologic Agents

    Efficacy of Biologic Treatment and MTX Combination Therapy in MTX-Experienced Patients

    Review of Clinical Trials and Meta-analyses of Biologic Agents

    Efficacy of Combined Biologic Treatment and DMARD Therapy in DMARD-Experienced Patients

    Selected Basal Insulin Clinical Trials

    Insulin Degludec BEGIN Meta-Analysis

    Clinical Trials Comparing GLP-1 Receptor Agonists

    Comparative Efficacy of GLP-1 Receptor Agonists

    Clinical Trials Comparing GLP-1 Receptor Agonists

    Comparison of GLP-1 Receptor Agonists

    Introduction

    FDA Approval for Biologics

    Introduction

    FDA Approval for Biologics

    Foundational Clinical Trials

    Radiotherapy Studies

    Foundational Clinical Trials

    Postoperative Radiotherapy and Chemoradiotherapy

    Foundational Clinical Trials

    Concurrent Chemoradiation Regimens: Incidence of Acute Adverse Events

    Foundational Clinical Trials

    Induction Chemotherapy: VA Cooperative and RTOG 91-11 Studies

    Foundational Clinical Trials

    New Targeted Therapies: Targeted Therapies as Single Therapies

    Foundational Clinical Trials

    Salivary Gland Cancer

    Soft Tissue Sarcomas (STSs)

    Foundational Clinical Trials: Surgery and Radiotherapy

    Soft Tissue Sarcomas (STSs)

    Foundational Clinical Trials: Adjuvant Radiotherapy

    Soft Tissue Sarcomas (STSs)

    Foundational Clinical Trials: Adjuvant Chemotherapy (SMAC)

    Soft Tissue Sarcomas (STSs)

    Foundational Clinical Trials: Adjuvant Chemotherapy - Survival

    Soft Tissue Sarcomas (STSs)

    Foundational Clinical Trials: Adjuvant Chemotherapy - GIST

    Soft Tissue Sarcomas (STSs)

    Foundational Clinical Trials: Resistance to Imatinib

    Soft Tissue Sarcomas (STSs)

    Foundational Clinical Trials: Neoadjuvant Chemotherapy

    Development of Monoclonal Antibodies

    Monoclonal Antibody Production in Hybridomas
    Monoclonal Antibody Production in CHO Cells
    M...

    Foundational Clinical Trials

    Concurrent Chemoradiation Regimens: Standard of Care

    Foundational Clinical Trials

    Induction Chemotherapy: TAX 232 and TAX 324 Studies

    Foundational Clinical Trials

    Recurrent Unresectable/Metastatic HNSCC

    Drug Development

    Biomarkers May Bridge the Gap between Animal Studies and Large Clinical Trials

    Introduction

    The Critical Path for Medical Product Development
    The Immune System Modulators
    Interactive...

    Introduction

    FDA Approval for Biologics
    How Does a Drug Get Approved?

    Introduction

    FDA Approval for Biologics
    How Does a Drug Get Approved?

    Clinical Applications of Monoclonal Antibodies

    Clinical Applications of Monoclonal Antibodies: Learning Objectives
    Detection, Diagnosis, and M...

    Introduction

    Introduction to Clinical Statistics

    Distribution Functions

    Binomial Distribution

    Combination Product Regulation

    Combination Products: One or Two Reviewers?

    Abatacept: Clinical Studies

    Abatacept: Clinical Studies

    Summary: Clinical Statistics

    How to Choose a Statistical Test

    Cholinesterase Inhibitors: Rivastigmine

    Clinical Studies: Overview

    Fibrates

    Side Effects, Efficacy, and Safety: Fibrates

    Acetylcholinesterase Inhibitors: Donepezil

    Acetylcholinesterase Inhibitors - Donepezil

    Ustekinumab

    Pivotal Trials: Overview
    Pivotal Trials: Trial Design
    Pivotal Trials: Endpoints
    Pivot...

    Golimumab: Clinical Studies

    Golimumab: Clinical Studies

    Adalimumab: Clinical Studies

    Adalimumab: Clinical Studies

    Current Therapies

    Disease Modifying Therapy (DMT): Rationale for Early Treatment

    Currently Approved Therapies: Novantrone

    Aubagio

    Bleeding in ACS: Clinical Definition of Bleeding

    Need for Standardization of Bleeding Definition

    Phase III Clinical Studies

    Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

    Currently Approved Therapies: Interferon Beta

    Rebif

    Currently Approved Therapies: Interferon Beta

    Betaseron/Extavia

    Statins

    Efficacy and Safety: Therapy Results

    Statistical Tests

    Significance Level

    Soft Tissue Sarcomas (STSs)

    Investigational Treatment Strategies: Soft Tissue Sarcoma Investigational Trials

    Bone Sarcoma

    Investigational Treatment Strategies: Selected Investigational Trials

    Phase 3 Clinical Studies

    Dulaglutide: REWIND

    Considerations for Developing a Protein Formulation

    Development Timeline

    The Future

    Future Applications for Biologics

    Distribution Functions

    Gaussian (Normal) and Skew Distributions
    Exponential Distributions
    Binomial Distribution

    PCSK9 Inhibitors

    Side Effects

    Drug Addiction Treatment Act of 2000

    Criteria and Physician Qualification

    Bleeding in ACS: Clinical Definition of Bleeding

    Challenges

    GLP-1 Receptor Agonists and Cardiovascular Events

    GLP-1 Receptor Agonists: Effect of on Cardiovascular Events

    Glycemic Control Intervention in Type 2 Diabetes: Heart2D

    Hyperglycemia and its Effect after Acute myocardial infaRction on cardiovascular outcomes in patient...

    Glycemic Control Intervention in Type 2 Diabetes: Treat-to-Target

    Treat-to-Target Trial: Glargine and Human NPH

    Bleeding in ACS: Clinical Definition of Bleeding

    Incidence of Bleeding

    Infliximab

    Infliximab Safety

    Infliximab

    Pivotal Trials: Efficacy of Maintenance
    Infliximab Safety

    Infliximab: Clinical Studies

    Infliximab: Clinical Studies

    Development of Monoclonal Antibodies

    Preclinical Testing of Therapeutic Antibodies

    Investigational Therapies

    Momelotinib (MMB; CYT387): JAK Inhibitor

    Marketplace

    Getting into the Market: The Approval Process

    Treatment Strategies

    Disease-Modifying Therapies

    Advancing Technologies

    Advanced Imaging Techniques: Magnetic Resonance Spectroscopy (MRS)

    Platelet Receptor Physiology

    IIb/IIIa as a Target

    Current Treatment

    Advanced Stage IV Melanoma: Second-Line Therapy

    Investigational Treatment Strategies

    Targeting the Molecular Pathways Controlling Tumor Cell Proliferation

    Investigational Treatment Strategies

    Pro-Apoptotic Agents & Chemosensitization to Overcome Drug Resistance: Chemosensitization

    Investigational Treatment Strategies

    Pro-Apoptotic Agents & Chemosensitization to Overcome Drug Resistance: Pro-apoptotic Agents Under In...

    Passive Immunization

    Bapineuzumab Phase II: Cognitive Measures

    Glycemic Control Intervention in Type 2 Diabetes: DURABLE

    The DURAbility of Basal Versus Lispro mix 75/25 Insulin Efficacy Trial (DURABLE)

    Glycemic Control Intervention in Type 2 Diabetes: 4-T

    Treating To Target in Type 2 Diabetes (4-T)

    Glycemic Control Intervention in Type 2 Diabetes: INITIATE

    INITIATing Insulin Therapy in Type 2 DiabEtes (INITIATE)

    Glycemic Control Intervention in Type 2 Diabetes: LANMET

    Insulin gLArgine or NPH combined with METformin in type 2 diabetes (LANMET)

    Glycemic Control Intervention in Type 2 Diabetes: ORIGIN

    The Outcome Reduction with Initial Glargine INtervention trial (ORIGIN)

    Glycemic Control Intervention in Type 2 Diabetes: Treat-to-Target Trial with Insulin Detemir versus Insulin Glargine

    Treat-to-Target Trial: Insulin Detemir versus Glargine

    Non-biologic DMARDs: Methotrexate

    Pivotal Clinical Studies: Methotrexate

    Diagnosis of RA

    Overview - Diagnosis of RA

    Research Study Design

    Research Study Design

    Anatomy and Pathophysiology

    Clinical Examination: Ocular Melanoma

    Regulation of Biological Products and Drugs

    Biological Product Regulation

    Treatment for Neuropsychiatric Symptoms in AD

    Treatment of Depression

    Currently Approved Therapies: Interferon Beta

    Avonex

    Summary: Clinical Statistics

    Types of Data
    How to Choose a Statistical Test

    Regulation of Biosimilars

    Evidence Generation: Clinical

    Cost-Effectiveness Studies: Mahmoudi and Sobieraj, 2013

    Methods: Studies Included in the Analysis and Quality-of-Life Measures

    Treatment for Neuropsychiatric Symptoms in AD

    Treatment of Psychosis and Agitation

    Summary: Cancer-associated VTE

    Summary: Cancer-associated VTE

    Active Immunization

    AN1792 Phase I Safety Trial

    Non-biologic DMARDs: Methotrexate

    Pivotal Clinical Studies

    Economic Burden of Stroke

    Stroke Risk Based Upon Anticoagulation Use

    Introduction

    Biomarkers and Development of Clinical Therapeutics: ADNI

    Medical Device Regulation

    Regulatory Classifications: Investigational Device Exemption (IDE)

    Acetylcholinesterase Inhibitors: Galantamine

    Dosage and Administration - Galantamine

    Cholinesterase Inhibitors: Galantamine

    Clinical Studies - Overview

    Drug Development

    Biomarkers to Monitor and Track Biochemical Drug Effects

    Diagnostic Criteria

    Different Classification Criteria

    Diagnosis of RA

    2010 Rheumatoid Arthritis Classification

    Emerging Hypotheses on Treatment

    Genetic Concepts: Chances for Success

    Therapeutic Regimens Recommended Antiretroviral Regimens

    Recommended Antiretroviral Regimens

    Monoclonal Antibodies in Action

    Conjugate Delivery: Antibody-Directed Enzyme Prodrug Therapy (ADEPT)

    Development of Monoclonal Antibodies

    Preclinical Safety Testing

    Ustekinumab

    Pivotal Trials: Overview

    Current Treatment

    NCCN Guidelines - Stage III and IV

    Current Treatment

    Post-Surgical Adjuvant Therapy

    Bone Sarcoma

    Investigational Treatment Strategies: Bone Sarcoma

    Active Immunization

    V950: Active Anti-Aβ Vaccine

    Genetic Markers

    Genetic Advances and Technologies: Advances Since the Human Genome Project

    Clopidogrel

    Drug Interactions and Hyporesponse

    Anakinra: Clinical Studies

    Anakinra: Clinical Studies

    Stent Thrombosis

    Definitions: Protocol Definitions and Potential Bias

    Government Regulation and Approval Pathways

    Drug Patents and Generics

    Cost-Effectiveness Studies: Harrington et al., 2013

    Methods Endpoints

    Currently Approved Therapies: Tecfidera

    Tecfidera

    Biosimilarity

    Demonstrating Biosimilarity

    Currently Approved Therapies: Novantrone

    Novantrone, Mitoxantrone

    Signs and Symptoms

    Damage to Specific CNS Regions

    Summary

    Summary: Existing and Emerging GLP-1 Therapies

    Basaglar Insulin Glargine

    Efficacy and Safety

    Basaglar Insulin Glargine

    ELEMENT Trials: Efficacy and Safety

    Summary

    Existing and Emerging GLP-1 Therapies

    Standard Agents: Selected Clinical Studies

    Vitamin K Antagonists (VKAs): Warfarin

    Psoriasis Therapies

    Retinoids: Clinical Efficacy

    Background: Osteoporosis

    Osteoporosis Background Information

    Biomarkers for the Diagnosis of AD

    MRI and Ventricular Expansion

    Controversies in Androgen Replacement Therapy

    Prostate - Testosterone Registry

    Therapeutic Regimens Recommended Antiretroviral Regimens

    Recommended Antiretroviral Regimens
    HAART Regimens

    Adalimumab

    Pivotal Trials

    Infliximab

    Pivotal Trials: Overview

    Etanercept

    Pivotal Trials: Overview

    PK Parameters

    Determinants of Pharmacokinetics (PK) and Drug Exposure and Pharmacokinetics

    Investigational Treatment Strategies

    Targeting the Molecular Pathways Controlling Tumor Cell Proliferation: Importance of Combination Str...

    Diagnosis and Management

    Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)

    Criteria for the Diagnosis of Dementia Due to Alzheimer's Disease

    Mini-Mental State Examination (MMSE)

    Acetylcholinesterase Inhibitors: Rivastigmine

    Dosage and Administration - Rivastigmine Oral Dosage

    NMDA Receptor Antagonist - Memantine

    Indication, Dosage and Administration

    PK Models

    Utility of PK Modeling

    Introduction

    Biomarkers and Development of Clinical Therapeutics

    Premix vs. Basal-Prandial

    Novomix 50 (BMI>30) or 70 (BMI≤30) at Breakfast and Lunch + Novomix 30 at Dinner Vs. Basal Pr...

    Currently Approved Therapies: Tysabri

    Currently Approved Therapies: Tysabri

    Non-Pharmacologic Treatments

    Integrative Response Therapy (IRT)

    First-line Treatment Options

    Introduction: First Time Treatment Options

    Treatment Effects

    Estimating Treatment Effects
    Binary Data
    Interactive Exercise: Estimating Treatment Effect...

    Statistical Tests

    Statistical Tests
    Significance Level
    P-Values
    Choosing a P-Value
    Interactive Exe...

    Biological Products/Biologics vs. Biosimilars

    Demonstrating Biosimilarity

    Summary: Osteoporosis Diagnosis

    Summary: Osteoporosis Diagnosis

    Biosimilars

    Benefits, Risks, Marketing, and Claims

    Phase II Data: Atrial Fibrillation Dosing

    Weitz Phase 2 NVAF Study

    Basaglar Insulin Glargine

    Immunogenicity

    Government Regulation and Approval Pathways

    U.S. Food and Drug Administration: Regulatory Oversight

    Additional Recommendations and Position Statements

    National Lipid Association (NLA) Recommendations for Patient-Centered Management of Dyslipidemia

    Biosimilarity

    What is Biosimilarity?, Demonstrating Biosimilarity

    Infliximab

    Pivotal Trials: Overview
    Psoriasis Trial I: Study Design
    Psoriasis Trial II: Study Design

    Etanercept

    Pivotal Trials: Overview
    Psoriasis Trial I: Study Design
    Psoriasis Trial II: Study Design

    The Future

    Development of Generics: Overview
    Future Applications for Biologics

    γ-Secretase Inhibition

    GSI-953 and GSI-953: Effects in Transgenic Mice and Aβ Levels

    Testosterone Replacement Therapy: Buccal Testosterone System

    Buccal Testosterone System: Clinical Studies

    Testosterone Replacement Therapy: Buccal Testosterone System

    Buccal Testosterone System

    Medical Device Regulation

    Regulatory Classifications

    GLP-1 Receptor Agonists and Weight Loss

    Efficacy of Liraglutide for Weight Loss Among Patients with Type 2 Diabetes

    Non-Bioequivalent Insulins

    BIOD-531 U-400

    Emerging Therapies

    Emerging Therapies Overview

    Biosimilars

    Benefits, Risks, and Patent Life

    Current Therapies

    Overview: Current Therapies for MS
    Treatment of Acute Relapses: Severe Relapses: Therapeutic P...

    Currently Approved Therapies: Novantrone

    Pivotal Trials

    Introduction

    The Critical Path for Medical Product Development

    Biomarkers to Predict the Rate of Cognitive Decline in AD

    FDG-PET by Voxel-Based Approaches

    Standard Agents: Clinical Studies

    Vitamin K Antagonists (VKAs): Warfarin

    Testosterone Replacement Therapy: Transdermal Testosterone Patch

    Transdermal Testosterone Patch: Clinical Studies

    Pharmacokinetics and Pharmacodynamics

    The Pharmacokinetics of Once-Weekly Dulaglutide in Patients with Renal Impairment

    Adalimumab

    Pivotal Trials
    Pivotal Trials: Psoriasis Trial I
    Psoriasis Trial I: Endpoints
    Psorias...

    Currently Approved Therapies: Gilenya

    Gilenya

    Basaglar Insulin Glargine

    Immunogenicity: Background

    Population PK

    Population PK Approach and PK Sampling and Constructing a Population PK Model

    Major Adverse Cardiac Events (MACE)

    Major Adverse Cardiac Events (MACE)

    Phase II Data: Atrial Fibrillation Dosing

    Salazar Population Pharmacokinetics

    Emerging Hypotheses on Treatment

    Emerging Hypotheses on Treatment: Myelination-Targeted Antibodies
    Cell Therapy
    Human Stem ...

    Research Study Design

    Types of Clinical Studies

    Government Regulation and Approval Pathways

    European Medicines Agency (EMA)

    AACE 2012 Guidelines for Management of Dyslipidemia and Prevention of Atherosclerosis

    Follow-Up and Monitoring

    Annotate: Hokusai

    Hokusai-VTE Trial

    Pharmacological Agents

    Ursodeoxycholic Acid (UDCA): Studies

    NMDA Receptor Antagonist - Memantine

    Memantine Clinical Studies: Overview

    Passive Immunization

    Intravenous Immunoglobulin (IVIg) Pilot Studies

    Drug Development

    Value of Biochemical Markers in Drug Development

    Cost-Effectiveness Studies: Harrington et al., 2013

    Study Overview: Harrington et al.

    Overview of Diagnosis

    Clinical Stroke Classification Schemes: TOAST and SSS-TOAST

    Overview: Cancer VTE

    VTE and Cancer

    2013 ACC/AHA Guidelines on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults

    Areas of Controversy

    Metastatic Breast Cancer: Introduction

    Metastatic Breast Cancer: Introduction

    Standard Agents: Selected Clinical Studies

    Fondaparinux: Treatment of Pulmonary Embolism

    Pharmacological Treatments

    First-line Therapies for PTSD

    Basaglar Insulin Glargine

    Immunogenicity

    PCSK9 Inhibitors

    Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)

    Marketplace

    Stroke
    Diabetes Mellitus
    Growth Defects
    Anemia
    Neutropenia
    Hepatitis
    R...

    Pharmacological Treatments

    Third-line Therapies for PTSD

    Diabetes Annotations

    Critical Appraisal

    Psoriasis Therapies

    Systemic Therapies: Retinoids
    Retinoids: Mechanism of Action
    Retinoids: Clinical Efficacy

    Standard Agents: Overview

    Unfractionated Heparin (UFH)

    Introduction to Pharmacology, Pharmacodynamics and Pharmacokinetics

    Pharmacokinetics (PK) Terminology and Drug Development

    Risk Factors

    Alcohol Dependence (Alcoholism)
    Interactive Exercise: Who's at Risk?
    Risk Factors Base...

    Considerations for Developing a Protein Formulation

    Considerations for Developing a Protein Formulation: Introduction
    Delivery Device
    Marketin...

    Element-1 Trial

    Element-2 Trial

    What is the Role of Toxicology in Drug Development?

    How Does Toxicology Relate to the Pre-Clinical Road Map?

    Standard Agents: Overview

    Unfractionated Heparin: Overview

    Overview of Diagnosis

    Stroke Scores Commonly Used

    Traditional Treatments

    JAK Inhibition: Ruxolitinib

    Platelet Receptor Physiology

    Substances That Cause Platelet Aggregation
    Activation Pathways
    ADP and Thromboxane A2

    Phase II Data: Atrial Fibrillation Dosing

    Chung Phase II Asian NVAF Study

    Phase II Data: Monitoring of Edoxaban - Pharmacodynamics

    Ogata Pharmacodynamics

    Phase III Data: ENGAGE AF-TIMI 48

    Methods: Patient Population, Study Design, and Endpoints

    Cost-Effectiveness Studies: Mahmoudi and Sobieraj, 2013

    Mahmoudi and Sobieraj Study: Study Overview

    Standard Agents: Selected Clinical Studies

    Fondaparinux: Treatment of Deep Vein Thrombosis

    Management Guidelines

    Interventions

    Strategies of Abuse-Deterrent Opioids

    Current Status and Challenges

    BED Pathophysiology

    Mu-Opioid Signaling Dysfunction

    Current Treatment of Binge Eating Disorder (BED)

    Treatment Goals and Guidelines

    PK in Action

    PK Prediction

    Advancing Technologies

    Biomarkers: Disease Process-Specific Biomarkers
    Biomarkers: Inflammation Biomarkers
    Biomar...

    Overview of Diagnosis

    Clinical Stroke Classification Schemes: Overview and Outcomes

    Monoclonal Antibodies in Action

    Effector Mechanisms - Overview
    Neutralization of Circulating Factor
    Antibody-Dependent Cel...

    Risk Factors

    Who's at Risk for Having Children with FASD?
    Risk Factors Based on Study Population
    In...

    Phase I Data: Pharmacokinetic Parameters

    Ogata Pharmacokinetics: Overview

    Glucose Measures: Self-Monitoring

    Glucose Meters, SMBG, Continuous Glucose Monitoring (CGM)

    Treatment

    Pharmacotherapy - Statins

    Basaglar Insulin Glargine

    ELEMENT 1: Efficacy and Safety

    Statins

    Side Effects

    Annotate: ENGAGE

    Edoxaban versus Warfarin in Patients with Atrial Fibrillation

    Etiology of Hypertension

    Risk Factors

    PK/PD of Basaglar

    Cancer Immunotherapy

    Adoptive T Cell Transfer

    What is the Role of Toxicology in Drug Development?

    How Does Toxicology Relate to the Pre-Clinical Road Map?
    Safety Pharmacology
    In Vivo and I...

    Methods and Instruments for Bone Densitometry

    Vertebral Fracture Assessment (VFA): DXA Imaging of the Spine for Detection of Vertebral Fractures

    Management of Colorectal Cancer

    Targeted Therapies

    VTE Clinical Picture: Risk Factors and Comorbid States

    Risk Factors and Comorbid States

    Diabetes Annotations

    Abasaglar insulin glargine

    Diabetes Annotations

    Jardiance

    Diagnosis and Treatment

    Enzyme Replacement Therapy (ERT)

    Basaglar Insulin Glargine

    Efficacy and Safety: ELEMENT 2 Endpoints

    Treatment

    Pharmacotherapy - Cholesterol Absorption Inhibitor

    Ticlopidine

    Ticlopidine: Overview

    Summary of Approved Therapies

    Efficacy of Approved Multiple Sclerosis Therapies

    VTE Clinical Picture: Risk Factors and Comorbid States

    Risk Factors and Comorbid States

    Etanercept

    Safety

    Diabetic Nephropathy

    Treatment Components: Statins, Lovastatin and Ezetimibe

    SLE Treatments: MAbs/Biologics

    Abatacept: Side Effects

    Standard Agents: Clinical Studies

    Unfractionated Heparin (UFH) and Low-Molecular-Weight Heparins (LMWHs)

    Investigational Therapies

    Momelotinib (MMB, CYT387)

    Current Therapies

    Intensive Immune Suppression: Chemotherapeutic Agents

    Country-Specific Definitions and Regulatory Guidelines

    South Korea Ministry of Food and Drug Safety (MFDS)

    Early Stages for Developing a Formulation

    IND/Phase 1 Formulation

    Prognosis

    Clinical Scoring Systems: EDSS Limitations

    Standard Agents: Selected Clinical Studies

    Unfractionated Heparin (UFH) and Low Molecular Weight Heparins (LMWHs)

    Phase III Clinical Studies

    Summary of Safety and Tolerability Across the AWARD Program

    Rituximab: Clinical Studies

    Rituximab: Clinical Studies

    Standard Agents: Overview

    Fondaparinux: Overview

    Biomarkers for the Prediction of MCI Conversion to AD

    MRI

    Diabetes Annotations

    Humalog 200 units/ml KwikPen SmPC

    Thienopyridines

    Ticlopidine (TICLID)

    Current Therapies

    Intensive Immune Suppression: Cell Therapy

    Cost-Effectiveness Studies: Kansal et al., 2013

    Kansal Study: Results

    Clinical Scoring Systems and Prognosis

    EDSS Limitations

    SLE Treatments: MAbs/Biologics

    MAbs/Biologics: Abatacept
    Abatacept: Efficacy
    Abatacept: Side Effects

    Treatment and Prevention of Cancer-associated VTE

    Outpatients receiving chemotherapy: Agnelli et al, 2009

    Biologics in Current Use - Abatacept

    Warnings: Abatacept

    Standard Agents: Therapeutic Challenges

    Enoxaparin: Contraindications and Dalteparin: Warnings and Precautions

    Treatment and Prevention of Cancer-associated VTE

    Surgery Patients

    Country-Specific Definitions and Regulatory Guidelines

    India Ministry of Science and Technology (MST)

    Country-Specific Definitions and Regulatory Guidelines

    Health Canada

    Country-Specific Definitions and Regulatory Guidelines

    European Medicines Agency (EMA) Detailed Requirements

    Standard Agents: Therapeutic Challenges

    Fondaparinux: Warnings and Precautions

    Emerging Therapies

    Emerging Therapies

    Emerging Hypotheses on Treatment

    Genetic Concepts: Interleukin Receptors

    Monoclonal Antibodies

    Conjugated Monoclonal Antibodies

    Non-Bioequivalent Insulins

    Humulin R U-500: Safety and Efficacy

    Management

    Goals of Treatment

    Biosimilars

    Biosimilars Under Review

    Country-Specific Definitions and Regulatory Guidelines

    World Health Organization (WHO)

    Emerging Hypotheses on Treatment

    Immunological Concepts: Oral Immune-Modulating Drugs

    Emerging Hypotheses on Treatment

    Neurodegeneration: Direct Neuroprotection

    Non-biologic DMARDs: Methotrexate

    Clinical Studies: Multidrug Combinations

    NCCN Guidelines

    Risk Category and Current Treatment Strategies

    Pharmacological Approaches

    Pharmacological Approaches for MDS Treatment

    Intensive Immune Suppression

    Intensive Immune Suppression for Non-Responders

    Treatment and Prevention of Cancer-associated VTE

    VTE Therapeutic Agents

    Country-Specific Definitions and Regulatory Guidelines

    Food and Drug Administration (FDA) Detailed Requirements

    Emerging Therapies for SLE

    Emerging Therapies for SLE

    Lenalidomide

    Lenalidomide: Adverse Reactions

    Clinical Features/Presentation

    Signs and Symptoms

    NMDA Receptor Antagonist - Memantine

    Memantine Precautions

    Goals of Male Hypogonadism Replacement Therapy

    Goals of Treatment for Male Hypogonadism

    Approved Parenteral Treatments for Multiple Sclerosis

    Approved Parenteral Therapies for RRMS: Extavia

    Emerging Hypotheses on Treatment

    Immunological Concepts: Monoclonal Antibodies

    Novel Oral Anticoagulants: Factor Xa Inhibitors - Apixaban

    Apixaban: Warning and Precautions

    Clinical Assessment Tools in Psoriasis

    Clinical Assessment Tools

    Early Stages for Developing a Formulation

    Molecular Characterization
    Development Timeline
    Pre-formulation Studies
    Manufacturabi...

    Statistical Analysis

    p-Values

    Atherothrombosis

    Superficial Plaque Erosion

    Novel Oral Anticoagulants: Direct Thrombin Inhibitors - Dabigatran

    Dabigatran: Contraindications, Warnings and Precautions

    Novel Oral Anticoagulants: Factor Xa Inhibitors - Rivaroxaban

    Rivaroxaban: Warnings and Precautions

    Management of Overweight/Obesity

    Evidence-Based Guidelines for Management of Overweight/Obesity
    Goals Management of Overweight/O...

    Management of Overweight/Obesity

    DSHEA Weight-Loss Products

    Disease Mechanism

    Neuronal Impairment

    Management of Patients with Atrial Fibrillation

    Overview of Strategies and Rate Control

    Novel Oral Anticoagulants: Factor Xa Inhibitors - Rivaroxaban

    Rivaroxaban: Overview, Indications, Dosage and Administration

    Novel Oral Anticoagulants: Factor Xa Inhibitors: Rivaroxaban

    Indications, Dosage and Administration

    Hypomethylating Agents

    Hypomethylating Agents

    Standard Agents: Therapeutic Challenges

    Enoxaparin: Warnings and Precautions

    Hypomethylating Agents

    Hypomethylating Agents

    Emerging Hypotheses on Treatment

    Neurodegeneration: Indirect Neuroprotection

    NCCN Guidelines

    Risk Category and Current Treatment Strategies
    Components of NCCN Guidelines
    Therapeutic A...

    Management Guidelines

    Stroke Centers and Stroke Systems of Care

    Current Therapies

    Complementary and Alternative Therapies: Complementary and Alternative Medicine (CAM)

    Monoclonal Antibodies

    Modifying the Monoclonal Antibody
    Neutralization of a Circulating Factor
    Receptor Blockade...

    Hypomethylating Agents

    Mechanism of DNA Methylation
    Gene Silencing Following DNA Methylation
    Hypomethylating Agen...

    Hypomethylating Agents

    Hypomethylating Agents

    Ticlopidine

    Ticlopidine: Warnings

    Current Therapies

    Disease Modifying Therapy (DMT): Approved Treatments for Multiple Sclerosis

    Atherothrombosis

    Overview: Atherothrombosis
    Interactivity: Unstable Plaque
    Interactivity: Thrombus Formatio...

    What is the Role of Toxicology in Drug Discovery and Development?

    Toxicology in the Pharmaceutical Industry
    The Role of Toxicology in Drug Discovery and Developm...

    Specifications and Sign-off (What are the Different Tox Strategies for Small and Large Molecules?)

    Toxicology Studies for Small and Large Molecules

    What is the Role of Toxicology in Drug Discovery and Development?

    Toxicology in the Pharmaceutical Industry

    What is the Role of Toxicology in Drug Discovery and Development?

    The Role of Toxicology in Drug Discovery and Development

    What is the Role of Toxicology in Drug Discovery and Development?

    Toxicology Studies in Drug Development

    How Does Toxicity Work?

    How Does Toxicity Work?
    Drug Distribution
    Biotransformation
    Chemical Reactions
    E...

    How Does Toxicity Work?

    How Does Toxicity Work?

    How Does Toxicity Work?

    Drug Distribution

    How Does Toxicity Work?

    Biotransformation

    How Does Toxicity Work?

    Chemical Reactions

    How Does Toxicity Work?

    Exaggerated Pharmacology

    How Does Toxicity Work?

    Toxin Targets

    How Do Drugs Affect The Body?

    What is ADME?
    Absorption and Distribution
    Biotransformation
    Local vs. Systemic Respon...

    How Do Drugs Affect The Body?

    What is ADME?

    How Do Drugs Affect The Body?

    Absorption and Distribution

    How Do Drugs Affect The Body?

    Biotransformation

    What Is the Relationship Between Dose and Response?

    Dose/Response Relationships
    Acute and Delayed Response

    What Is the Relationship Between Dose and Response?

    Dose/Response Relationships

    What Is the Relationship Between Dose and Response?

    Acute and Delayed Response

    How Might Drugs Affect Development?

    Male and Female Reproductive Systems
    Developmental Toxicity
    Development is a Complex Proce...

    How Might Drugs Affect Development?

    Male and Female Reproductive Systems

    How Might Drugs Affect Development?

    Developmental Toxicity

    How Might Drugs Affect Development?

    Development is a Complex Process

    How Might Drugs Affect Development?

    Thalidomide Action

    What is the Role of Toxicology in Drug Development?

    Safety Pharmacology

    What is the Role of Toxicology in Drug Development?

    In Vivo and In Vitro Testing

    What Kinds of In Vivo Tests are Used in Toxicology?

    In Vivo Test Assumptions
    Classes of Test
    Cellular Assays
    Molecular Assays
    In Sil...

    What Kinds of In Vivo Tests are Used in Toxicology?

    In Vivo Test Assumptions

    What Kinds of In Vivo Tests are Used in Toxicology?

    Classes of Test

    What Kinds of In Vivo Tests are Used in Toxicology?

    Cellular Assays

    What Kinds of In Vivo Tests are Used in Toxicology?

    Molecular Assays

    What Kinds of In Vivo Tests are Used in Toxicology?

    In Silico Assays

    How Do We Identify DNA Toxicants?

    In Vitro Tests
    In Vivo Tests

    How Do We Identify DNA Toxicants?

    In Vitro Tests

    How Do We Identify DNA Toxicants?

    In Vivo Tests

    How Do We Study Reproductive Toxicity?

    Male and Female Reproductive Toxicity
    FDA and EPA Guidelines

    How Do We Study Reproductive Toxicity?

    Male and Female Reproductive Toxicity

    How Do We Study Reproductive Toxicity?

    FDA and EPA Guidelines

    What Studies are Necessary to File an IND?

    Preclinical Study Requirements

    Specifications and Sign-off (What are the Different Tox Strategies for Small and Large Molecules?)

    Toxicology Studies for Small and Large Molecules
    Traditional Drugs

    Specifications and Sign-off (What are the Different Tox Strategies for Small and Large Molecules?)

    Traditional Drugs

    Specifications and Sign-off (What are the Different Tox Strategies for Small and Large Molecules?)

    Toxicology Studies for Small and Large Molecules

    What Tox Issues Emerge Post-IND?

    Changes in Midstream

    Types of Data

    Types of Data: Identification of Outcome Measurements
    Categorical: Binary (Dichotomous) Data

    Types of Data

    Types of Data: Identification of Outcome Measurements

    Types of Data

    Categorical: Binary (Dichotomous) Data

    Types of Data

    Categorical: Ordinal and Nominal Data

    Types of Data

    Numerical: Continuous Data

    Types of Data

    Numerical: Discrete Data (Counts of Events)

    Types of Data

    Influence of Data on Statistical Analysis

    Distribution Functions

    Gaussian (Normal) and Skew Distributions

    Distribution Functions

    Exponential Distributions

    Distribution Functions

    Poisson Distribution

    Distribution Functions

    Distribution Functions

    Statistical Summaries

    Data Summaries
    Equality Between Ratios
    Measures of Location
    Interactive Exercise: Mea...

    Statistical Summaries

    Data Summaries

    Statistical Summaries

    Equality Between Ratios

    Statistical Summaries

    Measures of Location
    Interactive Exercise: Mean, Mode, Median

    Statistical Summaries

    Measures of Location

    Statistical Summaries

    Measures of Spread (Variability): Overview

    Statistical Summaries

    Measures of Spread (Variability)

    Statistical Summaries

    Measures of Spread (Variability): Kaplan-Meier Estimates

    Treatment Effects

    Estimating Treatment Effects
    Binary Data

    Treatment Effects

    Estimating Treatment Effects

    Treatment Effects

    Binary Data

    Treatment Effects

    Continuous Data
    Discrete or Non-Normal Data
    Time-To-Event Data

    Treatment Effects

    Continuous Data

    Treatment Effects

    Discrete or Non-Normal Data

    Treatment Effects

    Time-To-Event Data

    Statistical Tests

    Statistical Tests

    Statistical Tests

    P-Values

    Statistical Tests

    Choosing a P-Value

    Statistical Tests

    Binary Data

    Statistical Tests

    Continuous Data

    Statistical Tests

    Discrete or Non-Normal Data

    Statistical Tests

    Time-To-Event (Survival) Data

    Summary: Clinical Statistics

    Types of Data

    How Do Drugs Affect The Body?

    Local vs. Systemic Responses

    Atherosclerosis: Risk Factors

    Risk Factors

    Atherosclerosis: Risk Factors

    Risk Factors

    Autoimmune Disease Processes

    Consequences of Autoimmune Diseases: TNF-α In Autoimmune Disease: Potential Harm OR Benefit?

    Passive Immunization

    Solanezumab Phase III

    Prognosis

    Prognostic Factors: First Interattack Interval
    Prognostic Factors: Summary of Prognostic Factor...

    Passive Immunization

    Bapineuzumab Phase III

    Symptomatic Therapies

    Symptomatic Therapies

    Lenalidomide

    Lenalidomide: Proposed Mechanism of Action
    Lenalidomide: Overview
    Lenalidomide: Indication...

    Steroids

    Glucocorticoids: Mode of Action
    The Anti-Inflammatory Effects of Corticosteroids
    Glucocort...

    Steroids

    Glucocorticoids: Side Effects

    Monoclonal Antibodies

    Production of Monoclonal Antibodies by Hybridomas
    Production of Monoclonal Antibodies in Mammal...

    Introduction to Monoclonal Antibodies

    Four General Classes of mAb Therapies

    Introduction to Monoclonal Antibodies

    Antibodies as Therapy
    Early Antibody Therapy: Polyclonal Antibodies
    Hybridoma Technology: ...

    Autoimmune Disease Processes

    The Etiology of Autoimmune Disease
    The Etiology of Autoimmune Disease: Genetic Factors (Risk)

    Autoimmune Disease Processes

    Consequences of Autoimmune Diseases: Progression and Destruction in Autoimmune Disorders (Mechanisms...

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