Clinical Trials

Contents:

Introduction

    The Origins of Drugs
    Introduction to Clinical Trial Design
    Run-in Period
    Inclusion/Exclusion Criteria, Stratification and Subgroups – Part I
    Inclusion and Stratification Criteria – Part II
    Randomization, Allocation, and Binding
    Intent to Treat Analysis vs. Per Protocol Analysis
    Biostatistics – Part I
    Biostatistics – Part II
    Introduction to Endpoints for Clinical Trials in Pharmacology
    Endpoints in Clinical Trials on Solid Tumors – Objective Response
    Oncology Endpoints: Overall Survival and Profession-Free Survival
    Oncology Endpoints:  Time to Progression
    Oncology Endpoint: Disease-Free Survival
    Oncology Endpoint: Time to Distant Metastasis
    Neoadjuvant Therapy vs. Adjuvant Therapy
    Hematological Cancers
    Biomarkers and Personalized Medicine
    Endpoints in Immune Diseases
    Endpoints in Clinical Trials on Infections
    Health-Related Quality of Life
    Health-Related Quality of Life Instruments for Immune Disorders
    Health-Related Quality of Life Instruments and Infections
    Drug Safety
    Mechanisms of Action, Part I
    Mechanisms of Action, Part II – Cancer
    Mechanisms of Action, Part III – Immune Disorders
    Mechanisms of Action, Part IV- Infections
    Consent Forms
    Package Inserts
    Regulatory Approval
    Patents