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Clinical Trials I
Study Course Description
Course Description Statuss:Approved
Course Description Version:5.00
Study Course Accepted:14.03.2024 11:50:40
| Study Course Information | |||||||||
| Course Code: | SL_107 | LQF level: | Level 7 | ||||||
| Credit Points: | 4.00 | ECTS: | 6.00 | ||||||
| Branch of Science: | Mathematics; Theory of Probability and Mathematical Statistics | Target Audience: | Life Science | ||||||
| Study Course Supervisor | |||||||||
| Course Supervisor: | Ziad Taib | ||||||||
| Study Course Implementer | |||||||||
| Structural Unit: | Statistics Unit | ||||||||
| The Head of Structural Unit: | |||||||||
| Contacts: | 14 Baložu street, Riga, statistika rsu[pnkts]lv, +371 67060897 | ||||||||
| Study Course Planning | |||||||||
| Full-Time - Semester No.1 | |||||||||
| Lectures (count) | 18 | Lecture Length (academic hours) | 2 | Total Contact Hours of Lectures | 36 | ||||
| Classes (count) | 6 | Class Length (academic hours) | 2 | Total Contact Hours of Classes | 12 | ||||
| Total Contact Hours | 48 | ||||||||
| Part-Time - Semester No.1 | |||||||||
| Lectures (count) | 16 | Lecture Length (academic hours) | 1 | Total Contact Hours of Lectures | 16 | ||||
| Classes (count) | 6 | Class Length (academic hours) | 2 | Total Contact Hours of Classes | 12 | ||||
| Total Contact Hours | 28 | ||||||||
| Study course description | |||||||||
| Preliminary Knowledge: | To follow this course, the student is required to be familiar with basic mathematical and statistical concepts, as well as have computer skills. | ||||||||
| Objective: | Clinical trials, as opposed to epidemiological studies, are prospectively planned experiments to obtain data-based evidence regarding the efficacy and/or safety of one or several treatments. The aim of this course, which is one of two courses on design and analysis of clinical trials, is twofold: (i) to explain the concept of a clinical trial and account for the main ingredients of such trials; (ii) to explain and explore the main statistical concepts and methods used in the design and analysis of clinical trials. The emphasis is on how such methods can be used in practice especially in connection to convenient software packages. | ||||||||
| Topic Layout (Full-Time) | |||||||||
| No. | Topic | Type of Implementation | Number | Venue | |||||
| 1 | Introduction to clinical trials | Lectures | 1.00 | auditorium | |||||
| 2 | Basic statistical notions in clinical trials | Lectures | 1.00 | auditorium | |||||
| 3 | Planning and randomization | Lectures | 1.00 | auditorium | |||||
| 4 | Project work – discussion no. 1 on previous topics | Classes | 1.00 | computer room | |||||
| 5 | Basic designs for clinical trials | Lectures | 1.00 | auditorium | |||||
| 6 | Classification of clinical trials | Lectures | 1.00 | auditorium | |||||
| 7 | Flow of data in clinical trials | Lectures | 1.00 | auditorium | |||||
| 8 | Project work – discussion no. 2 on previous topics | Classes | 1.00 | computer room | |||||
| 9 | Handling of continuous data | Lectures | 1.00 | auditorium | |||||
| 10 | Handling of categorical data | Lectures | 1.00 | auditorium | |||||
| 11 | Project work – discussion no. 3 on previous topics | Classes | 1.00 | computer room | |||||
| 12 | Handling of survival data | Lectures | 1.50 | auditorium | |||||
| 13 | Longitudinal data | Lectures | 1.00 | auditorium | |||||
| 14 | Sample size determination | Lectures | 1.50 | auditorium | |||||
| 15 | Project work – discussion no. 4 on previous topics | Classes | 1.00 | computer room | |||||
| 16 | Multiplicity and gate keeping | Lectures | 1.50 | auditorium | |||||
| 17 | Adaptive designs | Lectures | 1.50 | auditorium | |||||
| 18 | Missing data in clinical trials | Lectures | 1.00 | auditorium | |||||
| 19 | Project work – discussion no. 5 on previous topics | Classes | 1.00 | auditorium | |||||
| 20 | Statistical programming and data management for clinical trials | Lectures | 1.00 | auditorium | |||||
| 21 | Project work – discussion no. 6 on previous topics | Classes | 1.00 | computer room | |||||
| 22 | Patient reported outcomes | Lectures | 1.00 | auditorium | |||||
| Topic Layout (Part-Time) | |||||||||
| No. | Topic | Type of Implementation | Number | Venue | |||||
| 1 | Introduction to clinical trials | Lectures | 1.00 | auditorium | |||||
| 2 | Basic statistical notions in clinical trials | Lectures | 1.00 | auditorium | |||||
| 3 | Planning and randomization | Lectures | 1.00 | auditorium | |||||
| 4 | Project work – discussion no. 1 on previous topics | Classes | 1.00 | computer room | |||||
| 5 | Basic designs for clinical trials | Lectures | 1.00 | auditorium | |||||
| 6 | Classification of clinical trials | Lectures | 1.00 | auditorium | |||||
| 7 | Flow of data in clinical trials | Lectures | 1.00 | auditorium | |||||
| 8 | Project work – discussion no. 2 on previous topics | Classes | 1.00 | computer room | |||||
| 9 | Handling of continuous data | Lectures | 1.00 | auditorium | |||||
| 10 | Handling of categorical data | Lectures | 1.00 | auditorium | |||||
| 11 | Project work – discussion no. 3 on previous topics | Classes | 1.00 | computer room | |||||
| 12 | Handling of survival data | Lectures | 1.00 | auditorium | |||||
| 13 | Longitudinal data | Lectures | 1.00 | auditorium | |||||
| 14 | Sample size determination | Lectures | 1.00 | auditorium | |||||
| 15 | Project work – discussion no. 4 on previous topics | Classes | 1.00 | computer room | |||||
| 16 | Multiplicity and gate keeping | Lectures | 1.00 | auditorium | |||||
| 17 | Adaptive designs | Lectures | 1.00 | auditorium | |||||
| 18 | Missing data in clinical trials | Lectures | 1.00 | auditorium | |||||
| 19 | Project work – discussion no. 5 on previous topics | Classes | 1.00 | auditorium | |||||
| 20 | Statistical programming and data management for clinical trials | Lectures | 1.00 | auditorium | |||||
| 21 | Project work – discussion no. 6 on previous topics | Classes | 1.00 | computer room | |||||
| 22 | Patient reported outcomes | Lectures | 1.00 | auditorium | |||||
| Assessment | |||||||||
| Unaided Work: | • Individual work with the course material in preparation to lectures according to plan. • Individual analysis of selected assigned exercises. • Compulsory computer project – individual work in group on agreed computer assignments. Each student or group of students (of max 4) independently define a research question, plan an experiment, write a protocol, generate data, analyse the data, draw conclusions and report the work. Practical classes will be used for discussions about the projects and projects’ progress and answering unclear questions, to stimulate reflection on issues related to clinical trial design, conduct and interpretation. A portion of the time will be available for other computer exercises. However, the essential part of the work on the project should be carried out between the laboratory sessions. In order to evaluate the quality of the study course as a whole, the student must fill out the study course evaluation questionnaire on the Student Portal. | ||||||||
| Assessment Criteria: | Assessment on the 10-point scale according to the RSU Educational Order: • Closed book written exam – 50%. • Compulsory computer project – 50%. | ||||||||
| Final Examination (Full-Time): | Exam (Written) | ||||||||
| Final Examination (Part-Time): | Exam (Written) | ||||||||
| Learning Outcomes | |||||||||
| Knowledge: | After the course students will: • Show understanding of concepts related to clinical trials. • Demonstrate knowledge of basic statistical methods for clinical trials. • Know designs for clinical trials and randomization. • Explain and illustrate classification of clinical trials, cancer trials. • Expanding knowledge of continuous data, non-continuous data, longitudinal data, survival data. • Know multiplicity and sample size determination. | ||||||||
| Skills: | After having completed this course, the student will be able to use theory and methods for the most common types of clinical trials and their rationale including blinding, randomization and sample size calculation. The student is also supposed to master the most common statistical techniques for analysing data from trials and to perform appropriate statistical analyses for various design types covered in the course using software packages. | ||||||||
| Competencies: | After having completed this course the student is supposed to be competent to: • handle independently the design; • propose a theoretical design of a Randomized Controlled Trial (RCT) according to certain specifications; • plan various aspects of an RCT such as endpoints, comparators, sample size, randomization etc.; • evaluate various alternative designs and to introduce both specialists in the field and non-specialists; • professionally handle the analysis of the most common types of clinical trials, including blinding, randomization and sample size calculation. Moreover, the student will master the most used statistical techniques for analysing such trials, including data analysis of clinical trials using adequate method accordingly to guidelines as well as implementing innovative statistical approaches to research. | ||||||||
| Bibliography | |||||||||
| No. | Reference | ||||||||
| Required Reading | |||||||||
| 1 | Shein-Chung Chow, Jen-Pei Liu. Design and Analysis of Clinical Trials: Concepts and Methodologies, Wiley Series in Probability and Statistics. John Wiley & Sons Inc., 2013. | ||||||||
| Additional Reading | |||||||||
| 1 | Guidance documents e.g. the ICH guideline E9: Statistical Principles for Clinical Trials. | ||||||||
