Veidlapa Nr. M-3 (8)
Study Course Description
Clinical Trials II
Course Code
SL_115
Branch of Science
Other natural sciences
ECTS
6.00
Target Audience
Life Science
LQF
Level 7
Study Type And Form
Full-Time; Part-Time
Study Course Implementer
Course Supervisor
Agita Melbārde-Kelmere
Structure Unit Manager
Andrejs Ivanovs
Structural Unit
Statistics Unit
Contacts
23 Kapselu street, 2nd floor, Riga, statistika@rsu.lv, +371 67060897
About Study Course
Objective
There are, broadly speaking, two types of studies in biomedical research – randomized experiments and observational studies. Such studies range from pilot animal studies to clinical trials and epidemiological studies. In this course, the term clinical trial is to be understood in a wide sense as a prospective randomised study involving human subjects. The main purpose of a clinical trial is to assess the efficacy and safety of a treatment such as a drug, a medical device or even surgery or certain paramedical treatments such as traditional medicine. The course tries to adopt a patient centric view of clinical trials and thus to cover the safety aspect rather that efficacy as well as various types of ethical issues arising when planning, conducting, reporting clinical trials. While doing so, the emphasis will be on statistical issues whereas guidelines for “ethical statistical practice” will be discussed. Such guidelines are relevant for all types of studies in biomedical research including animal studies but are especially important for studies involving human subjects. The safety aspect of clinical trials aspect will also be presented on the level of an individual trial either in (i) special safety trials with safety endpoints or in efficacy trials where various types of adverse events are monitored or in (ii) analyses of safety data using meta-analysis methods and pharmacovigilance studies monitoring marketed drugs. We will also discuss precision medicine, i.e. attempts to explore how treatments can be tailored to individual patients based on relevant biomarkers. This leads us to exploring how such biomarkers can be validated for use in clinical trials and how diagnostic tests can be performed based on these biomarkers. Finally, decision making based on quantitative criteria e.g. Go/No-Go decisions after each trial is also presented.
Preliminary Knowledge
To follow this course, the student is required to be familiar with basic mathematical and statistical concepts. Such concepts correspond to the course Clinical Trials I. Moreover, computer skills are also required.
Learning Outcomes
Knowledge
1.After the course students will: • distinguish research Ethics and ethics of Clinical Trials concerning: Planning and Design – Conduct – Reporting. • have gained in-depth knowledge about safety clinical trials. • define and explain pharmaco-vigilance. • define statistical issues in Precision medicine. • list diagnostic tests. • discuss about quantitative decision making in clinical trials.
Skills
1.The course provides the students with the necessary knowledge and skills to perform planning, monitoring and to carry out analysis of clinical trials while taking an ethical patient centric perspective. This includes patient safety, giving the right treatment to the right patients and making evidence-based decisions based on trial data.
Competences
1.After having completed this course the student will be competent to apply various ethical principles in biomedical research, to take an ethical holistic ethical attitude to clinical trials when evaluating various alternative designs based on certain specifications: endpoints, comparators, sample size, randomization etc., as well as to be critical of the implication for statistical practice in terms of planning, conducting and reporting of such studies. Moreover, the student will be able to handle safety issues in clinical trials both on the level of individual trials and in meta analyses of groups of trials, analyse data from clinical trials using adequate methods as per applicable ethical guidelines, provide go no go decision criteria at the planning stage and make inform decisions based on trial data at the end of the trial.
Assessment
Individual work
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Individual work |
-
|
-
|
|
• Individual work with the course material and compulsory literature in preparation to 19 lectures according to plan.
• Compulsory discussion at 5 workshops – active participation in group discussions at the workshops whereas each student or group of students (of max 4) will be given a discussion topic for independent preparation. Address the issue in question, the students need to take safety/ethics perspective into account.
|
||
Examination
|
Title
|
% from total grade
|
Grade
|
|---|---|---|
|
1.
Examination |
-
|
-
|
|
Assessment on the 10-point scale according to the RSU Educational Order:
• Compulsory discussion at the workshops – 50%.
• Closed book written exam – 50%.
|
||
Study Course Theme Plan
FULL-TIME
Part 1
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Safety issues in clinical trials.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Monitoring of clinical trials.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Computer room
|
2
|
Topics
|
Discussion on individual discussion topic.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Pharmaco-vigilance.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Precision medicine in clinical trials.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Biomarkers in clinical trials.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Computer room
|
2
|
Topics
|
Discussion on individual discussion topic.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Quantitative decision making in clinical trials.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Computer room
|
2
|
Topics
|
Discussion on individual discussion topic.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Ethics of biomedical research.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Ethics of clinical trials.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Statistical ethics and ethical statistics.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Computer room
|
2
|
Topics
|
Discussion on individual discussion topic.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Ethics in clinical trials: planning and design.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Ethics in clinical trials: conduct.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Ethics in clinical trials: reporting.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Computer room
|
2
|
Topics
|
Discussion on individual discussion topic.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Clinical trials for medical devices.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Dietary and food supplement trials.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
|
Repetition and preparation for the exam.
|
Total ECTS (Creditpoints):
6.00
Contact hours:
48 Academic Hours
Final Examination:
Exam (Written)
PART-TIME
Part 1
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Safety issues in clinical trials.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Monitoring of clinical trials.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Computer room
|
2
|
Topics
|
Discussion on individual discussion topic.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Pharmaco-vigilance.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Precision medicine in clinical trials.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Biomarkers in clinical trials.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Computer room
|
2
|
Topics
|
Discussion on individual discussion topic.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Quantitative decision making in clinical trials.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Computer room
|
2
|
Topics
|
Discussion on individual discussion topic.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Ethics of biomedical research.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Ethics of clinical trials.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Statistical ethics and ethical statistics.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Computer room
|
2
|
Topics
|
Discussion on individual discussion topic.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Ethics in clinical trials: planning and design.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Ethics in clinical trials: conduct.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Ethics in clinical trials: reporting.
|
-
Class/Seminar
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Computer room
|
2
|
Topics
|
Discussion on individual discussion topic.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Clinical trials for medical devices.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Dietary and food supplement trials.
|
-
Lecture
|
Modality
|
Location
|
Contact hours
|
|---|---|---|
|
On site
|
Auditorium
|
1
|
Topics
|
Repetition and preparation for the exam.
|
Total ECTS (Creditpoints):
6.00
Contact hours:
29 Academic Hours
Final Examination:
Exam (Written)
Bibliography
Required Reading
1.
Shein-Chung Chow, Jen-Pei Liu. Design and Analysis of Clinical Trials: Concepts and Methodologies, John Wiley & Sons, Inc. 2013Suitable for English stream
2.
Ethical Guidelines for Statistical Practice. Prepared by the Committee on Professional Ethics of the American Statistical Association
Additional Reading
1.
Panter A.T., Serba S. K. Handbook of Ethics in Quantitative Methodology. Rolledge, 2011.