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.
Lectures and Case Methods:
Dr. Sara Hurtado Barroso (shurtado@uic.es)
Dr. Cristina Moreta Moraleda (cmoreta@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 Introduction. Definition and Context of Clinical Trials
Topic 2. Types of Clinical Trials
Topic 3. Clinical Trial Design. Statistics. Pharmacovigilance
CM 1. Clinical Trial Protocol
Block II. Clinical Trial Management
Topic 4. Documentation and Legislation in Clinical Trials. Ethics and Quality. Good Clinical Practice
Block III. Applicability of Clinical Trials
Topic 5. Clinical Trials in Cancer
Topic 6. Clinical Trials in Neurological and Autoimmune Diseases
Seminars on Clinical Trials in Cancer and Neurological Diseases
CM 2. Clinical Session on Cancer Clinical Trials
CM 3. Clinical Session on Mental and Neurological Disease Clinical Trials
Seminars on Clinical Trials in Autoimmune and Metabolic Diseases
CM 4. Clinical Session on Autoimmune Disease Clinical Trials
CM 5. Clinical Session on Metabolic Disease Clinical Trials
CM 6. Clinical Session on Nutrition Clinical Trials
Teaching and learning activities
In person
Lectures – 18 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.
Evaluation systems and criteria
In person
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Students in the first call:
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Midterm multiple-choice exam: 15%
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Final multiple-choice exam: 60%
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Case method: 20%
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Attendance at seminars: 5%
Students who contribute interesting ideas or ask relevant questions that improve the quality of the class, whether during lectures or case methods, may receive an additional 5% for excellence. Only students who actively participate in the course are eligible for this grade.
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Students in the second call: the case method, midterm exam and seminar grades will be retained.
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Students in the third or subsequent calls: the case method grade will also be retained, although students may choose to attend the different methodologies again and receive a new grade.
General points to consider regarding the evaluation system:
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In order to average the grades, a minimum score of 5 is required on the final exam. In addition, the final average must be above 5 to pass the course.
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Exams (midterm and final) will include questions about the lectures (both the theory taught by instructors and that presented in expert seminars).
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Attendance at seminars and case method sessions is MANDATORY. Failure to attend seminars will result in failing the course, while failure to attend at least 80% of the case method sessions will result in a grade of 0 in the case method component. Absences will only be considered justified if they are covered by the official student regulations.
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Exams will be multiple-choice with four options. Correct answers will score +1, and incorrect ones will deduct -0.33.
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Attendance at theoretical classes is not mandatory, but students who attend must follow the guidelines provided by the instructor. If arriving late, they must enter quietly without disturbing the class.
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Misuse of electronic devices (understood as recording and distributing material of students or teachers during sessions, as well as using devices for non-educational or entertainment purposes) may result in expulsion from the class.
Evaluation period
- E1 12/01/2026 A21 18:00h
- E2 15/06/2026 A16 14:00h