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Duration
Identical coursesConcepts of Clinical Trials (B-KUL-G0B69A)
Cannot be taken as part of an examination contract
Beckers François (coordinator) | Beckers François | N. Aims
The students will learn the key concepts of clinical trials in drug development from early to late stage post-marketing studies, understanding the importance of the different elements and types of study designs. The students will also get insight on how clinical trials are run in practice in the regulatory framework from the targeted product profile to the actual submission for marketing authorization. Specific statistical concept that need to be dealt with will be addressed in the course (multiplicity, bias, dropouts, interim analyses, subgroup analyses, probability of success, etc.)
Previous knowledge
The student knows the fundamentals of descriptive statistics and statistical inference (e.g.: hypothesis testing, Type I error, power, …) together with basic concepts of statistical modelling, generalized linear models and survival analysis.
The student is able to use at least one statistical programing language (e.g.: SAS, R, Python, Matlab,…), knowing the basics and able to learn by examples.
Identical courses
This course is identical to the following courses:
G0B69B : Concepts of Clinical Trials
Is included in these courses of study
- Master of Statistics and Data Science (on campus) (Leuven) (Statistics and Data Science for Biometrics) 120 ects.
- Courses for Exchange Students Faculty of Science (Leuven)
- Master in de bio-ingenieurswetenschappen: levensmiddelenwetenschappen en voeding (Leuven) (Major voeding en gezondheid) 120 ects.
Activities
4 ects. Concepts of Clinical Trials (B-KUL-G0B69a)
Content
In the first part of the course, the general context surrounding the value and use of clinical trials in drug development is being covered: What are clinical trials and why they are run? What is a Clinical Development Plan and Target Product Profile? What are the key steps from protocol to study report, actors and documents in clinical trials? What is the regulatory framework?
In the second part of the course, the main statistical concepts in clinical trials are addressed, notably: study designs, objectives-endpoints-decision criteria (hypothesis setting and sample size), multiplicity and possible source of bias. All these concepts are illustrated through various concrete examples.
In the third part of the course, some more advanced topics are treated with practical applications in clinical trials like survival analysis, Bayesian methods including probability of success to support decision making, adaptive and enrichment designs.
The course has mainly a non-technical character.
Format: more information
Course material (slides and homeworks)will be made available to the students electronically in Toledo and use as a basis during the course where additional examples will be provided.
The course aim at being interactive, prompting questions from the students.
Is also included in other courses
Evaluation
Evaluation: Concepts of Clinical Trials (B-KUL-G2B69a)
Explanation
Type : Homeworks outside the normal examination period and Exam during the normal examination period
Description of evaluation : Written and/or Oral
Type of questions : Open questions
After each class session, students will be given a home work on the covered topics. These homeworks are corrected with feedback returned to the students individually.
At the end of the semester a written and/or oral exam is also taking place on campus to assess proper understanding and mastering of the course concepts. The exam is closed book.
The homeworks and the exam will account for 50% each in the final evaluation. The result is calculated and communicated as a whole number on a scale of 20.
Information about retaking exams
Only the exam will be used for the final evaluation.
The exam will however cover the whole course content including the scope and content of the homeworks. The result is calculated and communicated as a whole number on a scale of 20.