The Randomized Clinical Trial

Títol del curs: The Randomized Clinical Trial

Impartit per: Emilia Bagiella. Department of Biostatistics, Mailman School of Public Health, Columbia University, New York.

Llengua del curs: Anglès

Dates i horaris del curs: 2, 3 i 5 de juliol. 10-14h.

Lloc: Aula 102

Tipus d'activitat i càrrega lectiva: Curs de 10 hores.

Reconeixement acadèmic: 1.5 crèdits

Data de matrícula: del 15 al 25 de maig

Course Description:
Students in this course will learn and practice the fundamental methods and concepts of the randomized clinical trial: protocol development, randomization, blindedness, patient recruitment, informed consent, compliance, sample size determination, crossovers, collaborative trials.

Course Learning Objectives:
Students who successfully complete this course will be able to:

• define an RCT, with comfortable familiarity with
• its key design features and statistical imperatives
• its strengths and limitations as a scientific experiment, and
• how these compare to, and differ from, the other major designs for assessing clinical interventions

• understand the relationships among pre-clinical studies, phase I, II, and III trials, and phase IV( post-marketing) studies

• understand the need for successful prospective planning and prespecification of all major components of an RCT, particularly but not only the statistical design

• understand the practical requirements for the successful implementation of RCTs - statistical, safety monitoring, data management, and regulatory issues

• assess the quality of a) the design, b) the conduct, and c) the reporting of efficacy and safety results of RCTs, and communicate these assessments to RCT clinical, statistical and data management professionals

Class Outline: Lectures will discuss the following topics:

1. Introduction to clinical trials, Rationale for Clinical Trials.
2. The clinical Protocol, Study designs.
3. Patient Selection, randomization and blindness.
4. Sample size determination.
5. Ethical considerations and the role of the IRB and the DSMB 6) Monitoring trial progress: Interim Analysis, Adverse Events.

Course evaluation:
Students will be evaluated on the basis of class participation and a project due at the end of the course. The final project will consist of a 10 page protocol for a hypothetical randomized clinical trial that achieves its appropriate goals to the greatest extent possible.

Reference text:
Lawrence M. Friedman, Curt D. Furberg, and David L. DeMets, Fundamentals of Clinical Trials, Third Edition, New York: Springer-Verlag, 1998.