Clinical Research for Neuro* stars

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Professor/instructor

Dr. Ahmad Alfaar

ECTS and Course type

ECTS: 4.3

Course type: Blended Learning, seminars, lectures, practical course, journal club

Target audience

MSc and PhD, Physicians

Date and time

Weekly, Saturdays Middle of January to End of February 2020, exact dates of the event will be announced.

Location

tba

Registration

Learning outcome

  • understanding the importance of different aspects of clinical research
  • applying concepts of clinical research in a safe environment

    • formulating research question
    • choosing the suitable study design for the experiment
    • writing the study protocol
    • designing data management tools and reports

  • evaluating clinical research projects and outcomes

Structure

MODULE 1 - BASICS OF CLINICAL RESEARCH
This module will introduce the participants to clinical research, its history, and its importance. They will familiarize themselves with different topics, including study question, population, study design, blinding, randomization, and clinical outcomes. The participants shall start their projects in this phase.

MODULE 2 - BASIC STATISTICS
In this module, the participants will learn the different data types and choosing the appropriate statistical test for each study question and data type. Moreover, they will apply basics of sample size calculation.

MODULE 3 - APPLIED STATISTICS
This module will introduce the participants to survival/Time-to-Event analysis, regression modeling, handling of missing data. Moreover, it will be a space for different topics in day-to-day data life of a clinical researcher, including research data management, secondary data, health records, and usage of machine learning with clinical data.

MODULE X - ETHICAL AND REGULATORY ASPECTS
Due to the malpractices happened over the last two centuries, research on human became bound with strict regulations. This module will offer the space for discussing legal and ethical aspects of clinical research and how they will affect the management of data and research on vulnerable groups.

MODULE 4 - STUDY DESIGNS
In continuation of module 1, this module will discuss clinical research phases and study designs in different study types.

MODULE 5 - PRACTICAL ASPECTS OF CLINICAL RESEARCH
This module is designed to discuss the cross-talk between clinical research and other disciplines, including; leadership, change management, and teamwork within clinical research teams, recruitment of patients, quality of life, and translational research.
Moreover, It will offer the participants the opportunity to learn about effective communication and dissemination while finalizing their projects, including protocols, publications, and peer reviews.
Besides the planned topics, the module will act as an arena for sharing thoughts about emerging topics in Clinical Research.

Assignments/Exam

The assignments include writing a study protocol, a journal article, and a review for another article.
Each week there will be a 10-minutes test for the previous week's knowledge.
Each student will be requested to present a small lecture on the topic.

Readings

Mandatory:

  • Gallin JI, Ognibene FP, editors. Principles and practice of clinical research. Academic Press; 2012 Jul 10.