BÄ°S712 - CLINICAL TRIALS

Course Name Code Semester Theory
(hours/week)		 Application
(hours/week)		 Credit ECTS
CLINICAL TRIALS BÄ°S712 1st Semester 3 0 3 7
PrequisitesHaving successfully completed the lectures BÄ°S 605 or BÄ°S 735
Course languageTurkish
Course typeElective 
Mode of DeliveryFace-to-Face 
Learning and teaching strategiesLecture
Discussion
 
Instructor (s) ASSIST. PROF. SEVÄ°LAY KARAHAN, PhD 
Course objectiveTo teach students different clinical trial designs, to introduce regulations, rules and guidelines, to teach methods for the calculation of required sample size for different design methods, to teach statistical methods which are required in data collection, data preprocessing, data analysis and presentation phases, to prepare students to take responsibility in the planning, conduct and reporting phases of clinical trials and to encourage them to take active part in a team of researchers from different disciplines by keeping in mind the role of biostatistics and biostatisticians in drug development process. 
Learning outcomes
  1. Students who take this course; learn all statistical procedures required in different phases, from the planning to the reporting phase of a clinical trial and rules which apply in conducting a clinical trial
  2. take responsibility for the conduct of clinical trials,
  3. understand the role and the importance of biostatisticians in clinical trials,
  4. perform their collaborative work with researchers from other disciplines,
  5. know and be able to apply the principles of good clinical practice.
Course ContentThe historical background of clinical trials, phases of clinical trials, definitions, guidelines and trial protocol. Different clinical trial designs and analysis, bias in clinical trials and ways of avoiding bias. Randomization and blinding. Determination of sample size, data cleaning. Intent to treat and per protocol analysis. Multicenter trials. Statistical methods used in bioavailability and bioequivalance studies. 
References1. Grieve, Andrew P. FAQs on statistics in clinical trials. Hill Rise, Richmond : Brookwood Medical Pub. Ltd., 1998.
2. Jennison, Christopher. Group sequential methods with applications to clinical trials.
Chapman and Hall/CRC Boca Raton 2000.
3. Pocock, Stuart J. Clinical trials : a practical approach. John Wiley Chichester 1991.
4. Rosenberger, William F. Randomization in clinical trials : theory and practice. Wiley-Interscience. New York, 2002.
5. Senn, Stephen. Cross-over trials in clinical research. John Wiley and Sons. Chichester 1993.
6. Friedman, L.M., Furberg, C.D., DeMets, D.L., Fundamentals of Clinical Trials. Mosby-Year Book, Inc. St Louis, 1985.
7. Kayaalp, OÄŸuz. Klinik Farmakolojinin Esasları. 2. Baskı, Hacettepe Tas Kitapçılık Ltd.Åžti. Ankara, 2001. 

Course outline weekly

WeeksTopics
Week 1Introduction to clinical trials.
Week 2Historical background of clinical trials. Phases of clinical trials.
Week 3Good clinical practice
Week 4Statistical principles in clinical trials, guidelines, national and international organizations and regulations.
Week 5Bias in clinical trials. Randomization and blinding.
Week 6Sample size calculation for clinical trials
Week 7Clinical trial protocol, case report forms.
Week 8Clinical trial designs and analysis I.
Week 9Clinical trial designs and analysis II.
Week 10Clinical trial designs and analysis III.
Week 11Midterm exam
Week 12Sequential analysis
Week 13Bioavailibility
Week 14Bioequivalence
Week 15Preparation to final exam
Week 16Final exam

Assesment methods

Course activitiesNumberPercentage
Attendance00
Laboratory00
Application00
Field activities00
Specific practical training00
Assignments410
Presentation215
Project00
Seminar00
Midterms125
Final exam150
Total100
Percentage of semester activities contributing grade succes850
Percentage of final exam contributing grade succes150
Total100

WORKLOAD AND ECTS CALCULATION

Activities Number Duration (hour) Total Work Load
Course Duration (x14) 14 3 42
Laboratory 0 0 0
Application000
Specific practical training000
Field activities000
Study Hours Out of Class (Preliminary work, reinforcement, ect)14456
Presentation / Seminar Preparation22040
Project000
Homework assignment4832
Midterms (Study duration)12020
Final Exam (Study duration) 12020
Total Workload3675210

Matrix Of The Course Learning Outcomes Versus Program Outcomes

D.9. Key Learning OutcomesContrubition level*
12345
1. A person who has a degree in Biostatistics, PhD: Has the knowledge to lead research planning, execution, and finalization, staying updated on literature and current studies.     X
2. Has sufficient information in the field, produces notable publications by addressing gaps in literature, both theoretically and practically.   X 
3. Asks questions about presentations, seminars, and studies at conferences or seminars, with a critical perspective.   X 
4. Has theoretical and practical knowledge of statistics at the level of expertise to determine the appropriate statistical analysis and examine the results in-depth.    X
5. Be proficient in computer use and statistical software, ensuring data suitability and recommending solutions for data management and analysis methods.    X 
6. Effectively conducts analysis issues through active participation in discussions, exchanging information with the thesis advisor, and presenting seminars.    X
7. Provides method suggestions in consultancy, does research planning, prepares research reports.    X
8. Maintains scientific accuracy and ethical values, remaining careful against any conscious or unconscious biases throughout the study.    X
9. Be able to present oral presentation and poster in national or international conferences.   X 
10. Be able to write a research project proposal independently, take part in a project, write a scientific study report.   X 
11. Be able to attend multidisciplinary studies, collaborate professionally in group settings and gain the ability to assign individuals in the group.     X
12. Integrates diverse disciplines to analyze and synthesize information, offering solutions.    X

*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest