Medical Education Course 2020
“Clinical Research Basics”
Cairo 13-14 March 2020
Mohamed Eid MD, MPH, MHA
Head of Clinical Development and Medical Affairs
Boehringer Ingelheim Pharmaceuticals Inc.
United States of America
Healthcare Professionals, Faculty Members and Staff in universities, academic institutes and pharmaceutical industry researchers
Clinical research refers to all research carried out in humans whether healthy or suffering from illness. It aims to improve knowledge of diseases, develop diagnostic methods, new treatments or medical devices to help provide better patient care, describe disease burden or expand scientific understanding to promote wellness, enhance prevention or provide for more effective therapies. Clinical research is traditionally conducted in a well-planned, carefully described and controlled manner. Clinical research is different from Clinical Practice. While Clinical Practice relies on established clinical guidelines and applies existing standards of medical care, Clinical Research on the other hand is the back-bone of creating new guidelines and elevating the standards of medical care. It is important for healthcare professionals and academic staff to understand the basics of Clinical Research so that they are better equipped to evaluate scientific and medical literature or conduct their own research activities.
To provide learners simplified concise knowledge and practical experience, including a brief supervised traineeship, to help increase their understanding of clinical research, the basics of statistics and the successful writingof research protocols.
1. To increase the learners’ awareness of the importance of clinical research
2. To increase the learners’ knowledge of process of “scientific inquiry” and stages of a clinical investigation
3. To strengthen learners’ skill in defining the different types of study designs, the importance of randomized controlled trials and the role of real-world data in generating evidence-based knowledge
4. To increase the learners’ understanding of the the key elements for a good research protocol and review the methods to increase the validity and generalizability of results in controlled trials
5. To know the meaning of common statistical terms and how they are used to create a study plan or report study results.
Education activities structure
Foundational and practical education activities: 10-h interactive and didactic education and two training
Workshop 1: Clinical Trials Workshop
Aiming to help participants strengthen their skills in reading and critically assessing existing scientific literature by increasing their ability to identify the study design, the study hypothesis, the statistical assumptions, and the data analysis methodology. Based on these improved skills, participants will be in a better position to evaluate the study conclusions and judge as to whether or not the study design, methodology and results support these conclusions.
Workshop 2: Writing Workshop
This hands-on activity aims to offer participants the opportunity to write their own brief “Study Outline” which could be used as the basis for effectively writing a full research protocol.
• Protocol samples
• Scoring systems
Other possible tools to give learners for dissemination
• Main articles (including guidelines) on medical writing
• Slide kit
• Electronic educational materials on USB