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Course Number: PHCL-456
Course Instructors Prof. Hisham Abou-Auda
Prof. Tawfeeg Najjar
Course Coordinator Prof. Hisham Abou-Auda
Topics covered
Part A (Prof. Abou-Auda)
1. Introduction to literature evaluation
2. Anatomy of scientific literature articles.
3. Clinical application of statistical analysis:
a. Basic concepts – Population and samples
b. Sampling techniques.
c. Descriptive and inferential statistics
d. Statistical inference
- Parametric and nonparametric statistics
- Regression and Correlation
4. Flowchart of inferential statistical analysis
5. Examples of statistical tests.
a. T-test
b. Chi-square test and Fisher's Exact test
c. One-way analysis of variance
d. Other relevant examples
6. Pitfalls in reporting statistical data in clinical literature.
7. How to evaluate drug companies' literature and advertisements.
Part B (Prof. Najjar)
1. Classification of biomedical literature
2. Experimental literatures
a. Clinical trials
b. N of 1 trial
c. Programmatic studies
d. In Vitro pharmaceutical studies (stability studies)
e. Bioequivalence studies
3. Observational literatures
a. Cohort studies
b. Case control studies
c. Cross sectional studies
d. Case report studies
e. Survey studies
f. Post-marketing surveillance studies
4. Overview literature
a. Qualitative nonsystematic reviews
b. Qualitative systematic reviews
c. Quantitative systematic review (meta-analysis)
5. Health related literature
a. Pharmacoeconomic studies
b. Quality of life studies
4. Resources used
1. Book: Drug Information: Guide for pharmacist 2nd edition (Chapter 7). By Patrick M. Malone & Kristian Wilconson
The material of this book were scanned and simplified.
2. Selected articles from biomedical journals
5. Learning Objectives
The student should be:
1. Familiar with the various classes (i.e. experimental, observational, overview and health related) of biomedical literature.
2. Aware of the situation when each type of biomedical literature is required
3. Understand the purpose of each type of these literature
4. Familiar with the design of each type and how it differs from the others
5. Familiar with some of the characteristics of each type that is required in the evaluation process.
6. Study questions
1. What are the differences between experimental and observational Literature?
2. When meta-analysis studies are usually required and conducted (this question is general for all types).
3. Identify the prevalence of characteristics of diseases in a population. Describe the purpose of the study type (this is a general question)
4. Give an example of a study design (Hypothetical) of a clinical trial (this is also a general question).
7. Assignment to be given
- At the beginning of this section each student will select randomly one of the various biomedical literature types to be presented at the end of the section.
- Each week the student will read at least two articles and be ready to participate in the next class.
8. Evaluation strategies
The students evaluated according to the following scheme:
1. At the beginning of each class, the students will take quiz on the articles that will be discussed in this class (these articles will be distributed to students in the previous class). 5 points
2. At the beginning of this section each student will randomly select one of the various biomedical literature types and prepare himself to present it at the end of the section as a practical exam. 10 points
3. Midterm theoretical exam 15 points
4. Final theoretical exam 20 points
Total: 50 points
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