Welcome To

Fellowship In Clinical Research

The course is useful for all clinicians and those who are interested in research and academia. There are 2 wholly-online-modules for the full fellowship. Each module is delivered over a 16-week period. This program is offered wholly online study using an interactive electronic platform, which produces a high-quality interface for learning and teaching through keynote lectures, a multitude of interactive discussion boards and a series of parallel journal clubs. Each module is 30 credits (300 hours of directed and self-directed learning – Table 1) at Masters level (LEVEL 7).

Program Overview

Award Modules Duration

CPD/CME (Standalone)

One module (in any order)

4 Months

Fellowship in Clinical Research

All 2 Modules

4 OR 8 Months

Syllabus

Module 1 : Fundamentals of Biomedical Statistics

  • Pro. Professor Ahmed Shokeir
  • Pro. Ahmed Harraz

Module 2 : Principles of Scientific Writing & Publishing

  • Pro. Ahmed Shokeir

Module 1:

Fundamentals of Biomedical Statistics

(Professor Professor Ahmed Shokeir/ Professor Ahmed Harraz)

1. Basic principles of statistics: Nomenclatures

2. Basic principles of statistics: Distribution of data

3. Why do we statistics? Statistical significance

Why do we do statistics? Study of risk/ Introduction to SPSS program

This lecture consists of 2 parts:

Part 1:
Explains the meaning of relative risk (RR), odds ratio (OR) and hazard ratio (HR) in correlation to studying the confidence interval.

Part 2 :
Introduction to SPSS program is given explaining the import and entry of data.

Summary algorithm and Introduction to SPSS program

Part 1:
All information of the previous lectures is summarized in a simple algorithm.

Part 2:
An introduction to SPSS program is given explaining the data transformation.

Selecting statistics: Univariable analysis: Basic principles/ practical applications

This lecture is containing 2 parts:

Part 1:
It explains the methods of presentation of univariable statistics which include one dependent and no independent variables. The lecture explains how to present normally distributed (symmetric continuous variables by mean ± SD, how to present non-normally distributed (asymmetric) continuous variables by median & range and how to present ordinal variables by median & range, as well as presenting nominal variables whether affected by time through calculation of the rate or not affected by time through calculation of proportion and percentage.

Part 2:
Practical applications on the calculation of mean, standard deviation, median and different types of presentation of the range including interquartile range.

Selecting statistics: Bivariable analysis (Part I): Basic principles/applications

This lecture consists of 2 parts:

Part 1:
Includes explanation of the basic principles of the types of statistical tests used for bivariable analysis which compares between one dependent variable and one independent variable such as student’s t-test, Mann–Whitney test and Pearson correlation coefficient.

Part 2:
Practical applications of the previously mentioned statistical tests.

Selecting statistics: Bivariable analysis (Part II): Basic principles/ practical applications

This lecture consists of 2 parts:

Part 1:
Continuation of explanation of the basic principles of different tests of bivariable analysis including Spearman rho, Chi-square and Fisher’s exact tests.

Part 2:
Practical applications of the previously mentioned tests.

Selecting statistics: Multivariable analysis (Part I): Basic principles/ practical applications

This lecture consists of 2 parts:

Part 1:
Explains the basic principles of the types of statistical tests used in multivariable analysis which are used for comparison between one dependent variable with 2 or more independent variables. Examples of these tests include analysis of variance (ANOVA) test, Kruskal-Wallis test, and logistic regression analysis.

Part 2:
Practical applications of the previously mentioned tests.

Selecting statistics: Multivariable analysis (Part II): Basic principles/practical applications

This lecture consists of 2 parts:

Part 1:
Includes continuation of explanation of the basic principles of the multivariable analysis including Kaplan Meier curve, Long-rank test and Cox regression.

Part 2:
Practical applications of the previously mentioned tests..

How to test the diagnostic performance of a new test (testing a test)?

In this lecture, there are explanation of the methods of assessment of the diagnostic performance of a new test including sensitivity, specificity, diagnostic accuracy, positive predictive value, and negative predictive value.
Moreover, the calculation of the cut-off values by using the Receiver Operator Characteristic (ROC) curve is explained with explanation of the meaning of the area under the curve (AUC).

Sample size: Basic principles/ practical applications

This lecture consists of 2 parts:

Part 1:
In this lecture, the types of statistical errors (Type I and Type II) are explained. In addition to that, the meaning and the difference between statistical significance and clinical importance are clarified. Following these, the formulae of calculation of the sample size in different types of medical studies whether observational or interventional are illustrated.

Part 2:

  • Practical applications through using G* power program (mean difference and proportion difference) are given.
  • This part also explains the interpretation of the results of a meta-analysis.
    Lectures of this sector are followed by multiple choice questions and their answers to consolidate the information mentioned in every lecture.

Module 2:

Principles of Scientific Writing and Publishing

(Professor Ahmed Shokeir)

1. Study design in medical research

This part is given in 2 lectures that explain the different designs of studies in medicine, including observational and experimental or interventional studies. The first lecture describes the different types of observational studies, including case-series, case-control, cross-sectional and cohort studies, whether prospective or retrospective. It also defines the different types of interventional or experimental studies, whether controlled or uncontrolled and the definition of the various types of controls. The
types of controlled studies are also mentioned, whether concurrent or sequential. Concurrent study types are explained, including randomised and non-randomized. Sequential studies, such as studies with self-control and cross-over studies, have also been clarified. In every type of study, a practical example is provided to understand the differences between all types of studies easily.

The second lecture explains how to carry out a randomised controlled trial (RCT), the gold standard in medicine. In this lecture, we mention the advantages and disadvantages of RCT, the difference between cohort and RCT, the types of controls in RCT, the methods of randomisation, the types of masking, the different phases of studies, whether pre-clinical and clinical trials, how to calculate the sample size in RCT, and the CONSORT flow chart. Practical examples are given to help people understand this vital topic easily.

  1. Study Design of Medical Research  (2 lectures)
  2. How to carry out Randomized controlled Trial (RCT) (3 lectures)
2. Evidence-based medicine (EBM)

This lecture discusses the meaning and history of EBM. Then, the goal, fundamental principles, components, and steps of EBM are discussed in detail. The lecture also explains how to critically appraise a research article by examining its relevance, validity, consistency, and importance.

An essential part of this lecture is an explanation of the Oxford system for evidence level and guidelines for its application in clinical practice. Then, the advantages and disadvantages of EBM are discussed.

Scientific writing and publishing

This section includes 5 lectures explaining in detail:
• How to write a scientific original article (2 lectures)
• Addressing Gaps in medical Writing
• How to write a research proposal for fund Raising
• How to systematic review and Meta Analysis
• How to discuss A thesis

3. Critical appraisal of the original article

The lecture illuminates the most essential items that should be critically evaluated by the reviewer, including fundamental items such as the journal, the researchers, the study design, and the subject. Moreover, the lecture gives advice on how to critically appraise all the detailed components of a manuscript or article, starting from the title and ending with the acknowledgement.

1- Critical appraisal of original article

4. Common ethical violations of scientific writing and publishing

This part included 2 lectures; in the first one, all ethical violations of scientific writing and publishing related to the authors, peer reviewers, editors and publisher are explained. In the second lecture, some case scenarios are given from Egypt and different parts of the world, including Europe, the USA and Japan.

This section will include hands-on training in critical appraisal of original articles, research proposals, and master’s and MD thesis through appraisal of true materials.

1- Common Ethical violation of scientific writing and publishing (2 lectures)
2- Common reasons of rejection of urological articles submitted for promotion in Egyptian universities

Accredited By

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Contact Us

Programme Director

Prof . Amr El-Husseini

amr.elhusseini@worldkidenyacademy.org

Programme Administrator :

administration@worldkidenyacademy.org

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