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HU Credits:
2
Degree/Cycle:
2nd degree (Master)
Responsible Department:
Public Health
Semester:
2nd Semester
Teaching Languages:
Hebrew
Campus:
Ein Karem
Course/Module Coordinator:
Prof. Ora Paltiel
Coordinator Office Hours:
Contact Prof. Paltiel by mail
Teaching Staff:
Prof Ora Paltiel,
Dr. Wiessam Abuahmad,
Ms. Chaya Mazuz
Course/Module description:
Clinical trials are the basis on which therapeutic decisions are made. New therapies and intervention must, nowadays, undergo rigorous experimental evaluation before they are approved. The field of Clinical trials includes study design, organization, monitoring, statistical analysis and ethical issues. Because of the problematics of conducting clinical trials with a large enough sample size to give definitive results, meta-analysis, combining results of several trials has been devised.
Course/Module aims:
This course aims to provide the student with theoretical, methodological, and statistical tools with which to evaluate and design clinical trials. Practical issues of data monitoring, new drug approval as well as ethical issues will be addressed. Finally an approach to meta-analysis will be provided. The students will have an opportunity to design a protocol in their field of interest.
Learning outcomes - On successful completion of this module, students should be able to:
1. Compose inclusion and exclusion criteria
2. Calculate sample size and power for continuous and categorial outcomes
3. Build a randomization platform
4. Recognize different clinical trials designs, their strengths and weaknesses
5. Be able to perform and analyze a meta-analysis
6. Be familiar with ethical guidelines for clinical trials
Attendance requirements(%):
Attendance required for GCP certification
Teaching arrangement and method of instruction:
Lectures, Exercises, quiz
Course/Module Content:
Introduction to clinical trials
Study population
Randomization
Sample size
Special designs
Analysis 1 Basic
Analysis 2 Multiplicity
control of bias
Ethics i
Protocols, data monitoring, recruitment
Required Reading:
Up to 10 articles are used to illustrate the learning material.
For exercises, and additional 6 articles are used.
Additional Reading Material:
Grading Scheme :
Submission assignments during the semester: Exercises / Essays / Audits / Reports / Forum / Simulation / others 80 %
Mid-terms exams 20 %
Additional information:
Prerequisites
Statistics
Students are encouraged to take/have taken more advanced statistics courses as well as epidemiology and research methods. Obligatory course for Master’s in Clinical Epidemiology and Pharm D.
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