KEP609 - CLINICAL RESEARCH IN CANCER
| Course Name | Code | Semester | Theory (hours/week) |
Application (hours/week) |
Credit | ECTS |
|---|---|---|---|---|---|---|
| CLINICAL RESEARCH IN CANCER | KEP609 | 2nd Semester | 3 | 0 | 3 | 7 |
| Prequisites | None | |||||
| Course language | Turkish | |||||
| Course type | Must | |||||
| Mode of Delivery | Face-to-Face | |||||
| Learning and teaching strategies | Lecture Discussion Question and Answer Preparing and/or Presenting Reports Project Design/Management | |||||
| Instructor (s) | Prof. Dr. Mutlu Hayran, Dr. Öğr.Gör. Deniz Yüce | |||||
| Course objective | The aim of this course is to enable students to develop a research project by understanding a clinical research protocol in cancer with information about clinical research types and design. | |||||
| Learning outcomes |
| |||||
| Course Content | Ethics and history in clinical research, Clinical research phases, Design research in clinical research: sample size, masking, randomization, protocol preparation in clinical trials, eligibility and final evaluation criteria for clinical trials, investigator and sponsor responsibilities in clinical trials, monitoring and surveys in clinical trials, clinical research analysis special topics: PP, ITT, safety analysis groups, presentation and reporting topics in clinical trials | |||||
| References | 1. S Green, J Benedetti, J Crowley. Clinical trials in oncology. Chapman & Hall / CRC, Florida, 2003. 2. L Friedman, CD Furberg, DL DeMets. Fundamentals of clinical trials. Springer-Verlag, New York, 1998. 3. S Piantadosi. Clinical Trials: A methodologic perspective. Wiley Series in Probability and Statistics, New York, 1997. 4. Kayaalp. Klinik Farmakolojinin Esasları. Hacettepe Taş Kitapçılık. Ankara, 2003. | |||||
Course outline weekly
| Weeks | Topics |
|---|---|
| Week 1 | Ethics and history in clinical research |
| Week 2 | Phase 1 clinical trials |
| Week 3 | Phase 2 clinical trials |
| Week 4 | Phase 3 clinical trials |
| Week 5 | Phase 4 clinical trials |
| Week 6 | Design issues in clinical research: sample size |
| Week 7 | Design issues in clinical research: masking, randomization |
| Week 8 | Preparation of protocols in clinical trials, eligibility for studies and final evaluation criteria |
| Week 9 | Researcher's responsibilities in clinical research |
| Week 10 | Responsibilities of the sponsor in clinical trials |
| Week 11 | Monitoring in clinical trials |
| Week 12 | Audit in clinical trials |
| Week 13 | Specific topics in clinical research analysis: PP, ITT |
| Week 14 | Specific topics in clinical research analysis: safety analysis |
| Week 15 | Final exam |
Assesment methods
| Course activities | Number | Percentage |
|---|---|---|
| Attendance | 15 | 10 |
| Laboratory | 0 | 0 |
| Application | 0 | 0 |
| Field activities | 0 | 0 |
| Specific practical training | 0 | 0 |
| Assignments | 0 | 0 |
| Presentation | 1 | 10 |
| Project | 1 | 10 |
| Seminar | 0 | 0 |
| Midterms | 1 | 20 |
| Final exam | 1 | 50 |
| Total | 100 | |
| Percentage of semester activities contributing grade succes | 18 | 50 |
| Percentage of final exam contributing grade succes | 1 | 50 |
| Total | 100 | |
WORKLOAD AND ECTS CALCULATION
| Activities | Number | Duration (hour) | Total Work Load |
|---|---|---|---|
| Course Duration (x14) | 15 | 2 | 30 |
| Laboratory | 0 | 0 | 0 |
| Application | 0 | 0 | 0 |
| Specific practical training | 0 | 0 | 0 |
| Field activities | 0 | 0 | 0 |
| Study Hours Out of Class (Preliminary work, reinforcement, ect) | 15 | 2 | 30 |
| Presentation / Seminar Preparation | 1 | 10 | 10 |
| Project | 1 | 40 | 40 |
| Homework assignment | 0 | 0 | 0 |
| Midterms (Study duration) | 1 | 50 | 50 |
| Final Exam (Study duration) | 1 | 50 | 50 |
| Total Workload | 34 | 154 | 210 |
Matrix Of The Course Learning Outcomes Versus Program Outcomes
| D.9. Key Learning Outcomes | Contrubition level* | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | |
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest