Clinical Trials

Course Information
TitleΚλινικές Δοκιμές / Clinical Trials
CodeE7
FacultyHealth Sciences
SchoolMedicine
Cycle / Level2nd / Postgraduate
Teaching PeriodSpring
CoordinatorApostolos Tsapas
CommonNo
StatusActive
Course ID600019000

Programme of Study: PPS Medical Research Methodology

Registered students: 18
OrientationAttendance TypeSemesterYearECTS
CoreElective Courses114
Class Information
Academic Year2023 – 2024
Class PeriodSpring
Faculty Instructors
Instructors from Other Categories
Class ID
600252058
Course Type 2021
Specific Foundation
Course Type 2016-2020
  • Scientific Area
Course Type 2011-2015
Specific Foundation / Core
Mode of Delivery
  • Face to face
  • Distance learning
Digital Course Content
Language of Instruction
  • English (Instruction)
Learning Outcomes
Upon completion of this elective module graduate students will be familiar with: - Formulation of a clear question for a randomized trial - Varying clinical trial designs (i.e. dose-finding, parallel, factorial, cross-over) - Different randomization schemes - Techniques for effective implementation of allocation concealment and blinding - Sample size calculations - Design of data collection forms using appropriate electronic data management tools - Preparation of a statistical analysis plan for a randomized trial incl. handling of missing data - Dissemination of study findings - Regulatory framework covering interventional studies in humans - Ethical issues and dilemmas that are unique to clinical trials
General Competences
  • Apply knowledge in practice
  • Work in teams
  • Work in an international context
  • Work in an interdisciplinary team
  • Generate new research ideas
  • Design and manage projects
Course Content (Syllabus)
1. Rationale and historical development of clinical trials 2. Trial phases and designs 3. Protocol development and resource planning 4. Compliance with regulatory requirements 5. Methods of randomization 6. Allocation concealment and blinding 7. Ethical issues 8. Sample size calculation 9. Data collection instruments and data management 10. Monitoring trial progress, quality assurance and strategies to boost recruitment 11. Preparation of statistical analysis plan 12. Basic principles of statistical analysis 13. Interpretation of results and dissemination of trial findings
Educational Material Types
  • Notes
  • Slide presentations
  • Video lectures
Use of Information and Communication Technologies
Use of ICT
  • Use of ICT in Course Teaching
  • Use of ICT in Laboratory Teaching
  • Use of ICT in Communication with Students
Description
Use of slides (file types: .ppt, .pptx, .pdf) Viewing of recorded lectures (file types: .mp4) Remote synchronous learning (Zoom) Provision / access to multimedia material (papers, websites, videos) (e-learning) Communication via online fora (e-learning) Evaluation via personal computers / multiple-choice questions, which are graded automatically (e-learning) Evaluation via personal computers / submission of files, which are graded by the tutors (e-learning)
Course Organization
ActivitiesWorkloadECTSIndividualTeamworkErasmus
Lectures200.8
Reading Assigment200.8
Project401.6✓
Exams200.8
Total1004
Student Assessment
Description
Evaluation via personal computers / multiple-choice questions, which are graded automatically (e-learning) Evaluation via personal computers / submission of files, which are graded by the tutors (e-learning)
Student Assessment methods
  • Written Exam with Multiple Choice Questions (Formative)
  • Written Assignment (Formative)
Bibliography
Additional bibliography for study
- Pocock, S.J. (1983). Clinical trials: a practical approach. John Wiley - Friedman, L.M. et al. (2010). Fundamentals of clinical trials. Springer - Torgerson D.J. & Torgerson C.J. (2008) Designing randomised trials. Palgrave Macmillan
Last Update
23-06-2022