Universitat Internacional de Catalunya
Clinical Trials in Biomedicine: from Research to Clinical Practice
Other languages of instruction: Catalan, English
Teaching staff
Coordinator:
Dra. HURTADO BARROSO, Sara - shurtado@uic.es
Questions will mainly be addressed during class sessions. For questions outside class hours, please contact the course coordinator by email.
Dr. Sara Hurtado Barroso (shurtado@uic.es)
Dr. Cristina Moreta Moraleda (cmoreta@uic.es)
Vega Espinosa Cale (vega.esca@uic.es)
Introduction
This course provides a comprehensive overview of clinical trials in biomedical research, covering their types, regulatory framework, and key ethical considerations. It examines the methodological principles underlying trial design and implementation, as well as their pivotal role in generating scientific evidence for the prevention, diagnosis, and treatment of major health conditions. Additionally, the course explores the translational impact of clinical trials and their contribution to therapeutic innovation and the advancement of clinical practice.
The course on clinical trials in biomedical research contributes to the Sustainable Development Goals (SDGs) of the 2030 Agenda, particularly SDGs 3, 9, 10, 12, and 17, through the promotion of health, people’s well-being, biomedical innovation, social equity, transparency in results, and strategic partnerships for scientific and social progress.
Pre-course requirements
It is recommended to have basic knowledge of cell and molecular biology, cancer biology, nutrition, pharmacology, and the pathological basis of human diseases.
Objectives
The objectives of the course are:
- To promote knowledge about the types of clinical trials and their various areas of application, as well as the regulatory framework and ethical considerations.
- To teach the translational nature of clinical trials in biomedical research and their applicability in clinical practice. To explain how clinical trials contribute to scientific advancement and clinical implementation, facilitating the transfer of knowledge from research to healthcare.
- To explain how clinical trials impact the prevention, diagnosis, and treatment of diseases such as cancer, mental and neurological disorders, autoimmune diseases, and metabolic conditions, in order to enhance the relevance of research for improving public health.
Competences/Learning outcomes of the degree programme
- CN14 - Identify the principles of biomedical sciences related to health, as well as the basic concepts and tools that have an impact on Biomedical Sciences and allow them to work in any of its fields (biomedical companies, bioinformatics labs, research laboratories, clinical analysis companies, etc.).
- CP05 - Apply biological foundations in the search for practical solutions to health problems, following ethical standards and scientific rigour and respecting fundamental equal rights between men and women, and the promotion of human rights and the values inherent in a peaceful society of democratic values that includes inclusive, non-discriminatory language without stereotypes.
Learning outcomes of the subject
By the end of the course, students should be able to:
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Recognise the different types of clinical trials and the context in which they take place.
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Identify the stages of preclinical and clinical research in clinical trials.
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Analyse the potential of translational research in clinical practice.
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Associate therapeutic advances with different areas of health.
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Design and manage a clinical trial within the field of biomedical sciences.
Syllabus
Block I. General Aspects of Clinical Trials
Topic 1. Course presentation. Definition and context of clinical trials
Topic 2. Types of clinical trials
Topic 3. Clinical trial design. Statistics. Pharmacovigilance
Block II. Clinical Trial Management
Topic 4. Documentation and legislation in clinical trials. Ethics and quality. Good Clinical Practice
CBL 1. Clinical trial protocol
CBL 2. Case Report Form
Simulation practice: recruitment and follow-up of a clinical trial
Block III. Clinical Trial Applications
Topic 5. Clinical trials in cancer
Topic 6. Clinical trials in neurological and autoimmune diseases
Seminars on clinical trials
CBL 3. Clinical trial session in cancer
CBL 4. Clinical trial session in mental and neurological diseases
CBL 5. Clinical trial session in autoimmune diseases
CBL 6. Clinical trial session in nutrition and metabolic diseases
Teaching and learning activities
In person
Lectures – 16 hours: presentation of a theoretical topic by the teaching staff. During the course, a series of seminars will be given by external experts on the topics covered in the lectures.
Clinical cases or case method (CM) – 12 hours: presentation of a real or hypothetical situation. Students work on the proposed questions in small groups or through active interaction with the teacher, and the answers are discussed. The teaching staff actively participates and, if necessary, provides new knowledge.
Practical classes – 2 hours: simulation-based practical session carried out at the Comprehensive Centre for Advanced Simulation (CISA), focusing on the concepts covered in the theoretical lectures under the supervision of the teaching staff.
Evaluation systems and criteria
In person
1. Students taking the course for the first time:
- Midterm multiple-choice examination: 15%
- Final multiple-choice examination: 60%
- Case-based learning assessment: 20%
- Practical sessions assessment: 5%
Students who contribute valuable ideas or ask relevant questions that enhance the quality of the classes may obtain an additional 5% excellence mark. This mark will only be awarded to students who actively participate throughout the course.
2. Students resitting the course (second examination period): the marks obtained for the case-based learning activities, practical sessions and midterm examination will be retained.
3. Students taking the course for the third or subsequent examination periods: the marks obtained for the case-based learning activities and practical sessions will be retained. However, students may choose to attend these learning activities again in order to obtain a new mark.
General assessment criteria:
- To be eligible for the calculation of the final grade, students must obtain a minimum mark of 5/10 in the final examination. In addition, the overall final grade must be 5/10 or higher to pass the course.
- The examinations (midterm and final) include questions covering the lecture content, including both the material taught by the teaching staff and the content delivered during seminars by invited expert speakers.
- Attendance at the case-based learning sessions and practical sessions is MANDATORY. Failure to attend at least 80% of the case-based learning sessions will result in a mark of 0 for this assessment component. Absences not covered by the University's student regulations will not be considered justified.
- The simulation practical session will be assessed using a rubric aligned with the learning outcomes and competencies of the session.
- The examinations will consist of multiple-choice questions with four answer options. Each correct answer will receive +1 point, while each incorrect answer will incur a penalty of −0.33 points.
- Attendance at lectures is not mandatory. However, students who attend are expected to comply with the rules established by the teaching staff. Students arriving late must enter the classroom quietly and without disrupting the session.
- Improper use of electronic devices (including recording or disseminating images or audio of students or teaching staff during teaching sessions, as well as using such devices for non-academic or recreational purposes) may result in removal from the classroom.