Universitat Internacional de Catalunya
Design and Monitoring of Clinical Trials
Other languages of instruction: English, Spanish
Teaching staff
Néstor Sánchez Martínez (coord.): nsanchezm@uic.es
Introduction
Clinical trials are the cornerstone for generating evidence in medicine and public health. This course focuses on the rigorous design and effective monitoring of clinical trials, covering everything from protocol formulation to results management and analysis. It will address ethical, regulatory, and methodological aspects, emphasizing the importance of quality and safety in clinical research. The training equips students with the tools needed to develop, oversee, and evaluate clinical trials that answer relevant research questions and comply with current regulations.
Pre-course requirements
It is recommended that students have a basic knowledge of:
• Epidemiology and fundamentals of clinical research.
• Applied statistics.
• Ethical principles in research.
Objectives
- Understand the fundamentals of clinical trial design
• Identify the types of trials and the essential elements of a clinical protocol. - Understand and apply monitoring strategies
• Learn about the methodologies for monitoring, ensuring quality, and managing data in clinical trials. - Develop the critical ability to evaluate clinical trials
• Analyze scientific literature and evaluate clinical protocols and trial results from an ethical and methodological perspective.
Competences/Learning outcomes of the degree programme
- CN01RA - Identify the ethical, legislative and humanitarian foundations of research in salut.
- CN02RA - Describir las metodologías y diseños de investigación más destacados en el ámbito de la salud.
- CN03RA - Identificar problemas de salud susceptibles de ser investigados
- CN04RA - Describe the main research protocols in the clinical setting
- CP01RA - Design an advanced research project on clinical aspects following ethical standards and scientific rigor and respecting the fundamental rights of equality between men and women, and the promotion of human rights and values typical of a culture of peace and democratic values, using a language that avoids androcentrism and stereotypes.
- CP02RA - Work in a multidisciplinary and multicultural team on a research project clinical.
- CP03RA - Communicate the stages of a clinical research project to the public specialized and non-specialized clearly and unambiguously
- HB01RA - Apply the scientific method, research design, advanced biostatistics and quantitative and qualitative data analysis tools to solve a question or test a hypothesis in the clinical setting.
- HB02RA - Use tools to critically evaluate projects, protocols and research articles, both qualitative and quantitative, in the field of Health Sciences
- HB03RA - Apply different bibliographic search strategies in a research project clinical research from the main databases in life sciences health.
Learning outcomes of the subject
At the end of the subject the student must be able to:
- Identify health problems that can be investigated.
- Use tools to critically evaluate projects, protocols and research articles, both qualitative and quantitative, in the field of health sciences.
- Communicate the stages of a clinical research project to specialized and non-specialized audiences in a clear and unambiguous way.
- To design an advanced research project on clinical aspects following ethical standards and scientific rigor and respecting the fundamental rights of equality between men and women, and the promotion of human rights and the values of a culture of peace and democratic values, using a language that avoids androcentrism and stereotypes.
- Identify the ethical, legislative and humanitarian foundations of health research.
Syllabus
Week 1: Design of the Clinical Trial
Learning Objectives:
• Understand the importance and structure of a clinical trial.
• Identify the key elements in developing a protocol (inclusion/exclusion criteria, intervention, outcome measures).
• Learn about the ethical and regulatory aspects, including informed consent and approval by ethics committees.
Content:
• Introduction to clinical trials and their relevance in research.
• Types of trials: randomized, controlled, multicenter.
• Essential elements of the protocol: objectives, design, criteria, and intervention strategies.
• Ethical and regulatory guidelines in clinical trials.
Week 2: Monitoring and Management of the Clinical Trial
Learning Objectives:
• Understand the monitoring strategies (centralized, remote, and on-site).
• Learn about quality assurance processes and data management.
• Identify techniques for patient follow-up and managing protocol deviations.
Content:
• Strategies and tools for monitoring clinical trials.
• Good Clinical Practices (GCP) and electronic data management systems.
• Patient follow-up and retention.
• Management of incidents and deviations in the trial.
Week 3: Data Analysis and Closure of the Clinical Trial
Learning Objectives:
• Develop and apply a statistical analysis plan to evaluate efficacy and safety.
• Interpret the results and manage the communication of findings.
• Learn the procedures for reporting adverse events and closing the trial.
Content:
• Statistical analysis plan and evaluation criteria.
• Analysis and interpretation of clinical results.
• Reporting of adverse events and post-trial follow-up.
• Preparation of the final report and strategies for publishing results.
Teaching and learning activities
Online
The course work will be organized into 4 weekly blocks throughout the course.
Each block will include the following components:
-
Video Classes and Mandatory Readings:
Every Thursday at 8:00 (HE), videos and readings will be made available to the students to provide context for the course content. The mandatory readings will outline the topics to be addressed, while the videos will highlight the most relevant points of these contents. Both the readings and video classes are mandatory and must be followed by all students. -
Exercises:
The weekly activities and exercises will be available from the same day the video classes are published and can be completed until the Thursday of the following week after the block starts at 20:00 (HE). These exercises are part of the assessment and must be completed before the start of the next block. -
Discussion Forums:
Each week, a debate topic will be proposed in which students are required to express an opinion on the given topic, as well as exchange views with other participants, confronting the interventions of other students and the teacher. Contributions should be engaging, foster participation, and promote an active debate among the students. Each contribution should have a maximum length of 10 lines. The debate will begin on Friday of the week the topic is introduced at 8:00 (HE) and will end on Monday at 20:00 (HE). -
Synchronous Session (Videoconference):
This will take place every Wednesday from 18:00 (HE) to 20:00 (HE) and will cover a relevant aspect of the course, delving into key topics and addressing students' questions about the content.
Evaluation systems and criteria
Online
|
Sistema de evaluación |
||
|
1 |
Evaluación continuada: adaptación online (GP) |
20% |
|
2 |
Trabajos escritos: adaptación online (PT) |
45% |
|
3 |
Exposición oral: adaptación online (GP) |
10% |
|
4 |
Pruebas escritas: adaptación online (OM)(PA) |
25% |
Sources and Weighting of Assessment:
- Continuous Assessment: Participation in forums (20%)
- Written Assignments: Weekly exercises (45%)
- Oral Presentation: Contributions to the synchronous session (10%)
- Written Exams: Synthesis test (25%)
Bibliography and resources
Book:
Friedman LM, Furberg CD, DeMets DL, Reboussin DM, Granger CB (2015). Fundamentals of Clinical Trials (5th ed). New-York: Springer.
Other sources:
CONSORT: http://www.consort-statement.org/
Spanish Agency for Medicines and Health Products: www.aemps.es
European Medicines Agency: http://www.ema.europa.eu/