|Date:||Thursday, February 5, 2015|
|Venue:||Alexandria University Staff Training Centre, Semouha|
|Organized by:||EgyBiotech for Research and Biotechnology|
|Facebook:||Clinical Trials Design, Management and Analysis (Module III)|
A modular course in health research based on the University of Leeds postgraduate diploma in health research. It is composed of 6 essential modules and 3 optional modules. Each module is 3 days long. Modules are taught once a month over Thursday, Friday and Saturday.
Aim of the course:
To provide a comprehensive step by step training on all aspects of the research process from idea development till research output.
Type of the course:
Modular course. Each module can be taken as a stand alone module or they can be combined into a full course. The course is composed of 6 essential modules and 3 optional modules which may or may not be selected by candidates for further study. Each module is taught over 2-3 full days.
Junior researchers, postgraduate degree students, CRAs and research trial coordinators, candidates interested in a research career, mid-career researchers aiming to start independent research projects
plenary session followed by small group activities, problem based learning sessions and practical application in all modules. For full course agenda , see files on event page.
Module 3: Clinical Trials Design, Management and Analysis
- Clinical trial design overview
- Design of phase I studies, phase II studies and phase III studies
- Issues in non randomized studies, before and after studies, historical controls and studies comparing paired organs
- Informed consent and ethical committee approvals
- GCP guidelines and EU directive for clinical trials
- Regulatory bodies and licensing
- How to randomize
- Controlling for bias and confounding
- Inclusion and exclusion criteria, stratification and subgroups
- End points in clinical trials: pharmacology endpoints, survival endpoints, response endpoints, time to event, quality of life endpoints
- Interpreting results in clinical trials