Objectives: This course will develop and apply the theory of clinical trial design and analysis, discuss the practical issues of financing and implementation of clinical trials, and describe issues of monitoring trials and working in cooperative groups. The scholar will design and present to a group of peers a concept sheet for a phase I/II and phase II/III clinical trial.
Course Content:
Hypothesis Generation and Formulation | Framework, Types, and Characteristics of Good Research Questions and formulating a testable hypothesis |
Introduction to POR | Definition of POR; Origins & Scientific Basis; Causality; Validity of Inference; Classification of Clinical Research |
| Measurement | Objectives, classes, and characteristics of measures in POR and their validity, accuracy, and precision |
Fundamentals of Clinical Trials | Study Objectives, Target Populations, Comparison Groups, Blinds, Outcomes and Endpoints |
Overview of the Process of Drug and Device Development | Preclinical and clinical development of drugs from an industrial prospective |
Statistical Issues in Clinical Trials | Sample Size/ Power Analysis; Randomization Procedures; Analytic Strategies - Sequential, Interval and Terminal; Analysis Plan |
Selecting and Measuring Outcomes and Study Implementation I | Outcomes: Selecting outcomes: who gets counted, clinical vs surrogates, and simple vs compound. Implementation: Defining, recruiting, consenting, initially assessing, tracking, and retaining participants; IRB submission. |
| Study Implementation II | Assessing Adherence; Study Start-up Study Monitoring for adverse events and interacting with the IRB; Completing the study, DSMB review |
| Complex Trial Design | Multi-centered studies, Crossover and Factorial Designs, equivalence vs superiority trials, and testing diagnostics |
Syllabus/Schedule