Universitat Internacional de Catalunya
Design and Monitoring of Clinical Trials
Other languages of instruction: English, Spanish
Teaching staff
Samantha Alvarez (coord.): salvarezs@uic.es
Introduction
Clinical trials are experiments evaluating new interventions in human health. Clinital Trials differ depending on the intervention such as drugs, surgeries, devices, behavioral interventions, community health programs or health care delivery.
Clinicial Trial designs are considered experiments as researchers decide the treatment that patients receive. Randomized clinical trials incorporate specific features to ensure an objective and impartial assessment of the benefits and risks of treatments. Their results are generally considered the highest level of evidence in determining treatment is effectiveness.
Pre-course requirements
Not applicable
Objectives
Course objectives:
In this course we will provide the necessary knowledge to understand the logic of clinical trials. Students will learn the characteristics and design of clinical trials, as well as thier benefits and limitations. You will learn the notions for assessing and implementing your design and put it into practice.
Specific objectives:
- To understand how to apply the a CT design.
- To formulate the kind of research questions that a clinical trial answers.
- To understand the different types of clinical trials.
- To properly apply randomization and masking.
- Familiarize the student with the practical processes involved when conducting a CT.
- To take into consideration the ethical aspects of CT designs.
- To correctly interpret and report the results of these studies.
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
In this course, we will work these contents:
- Experimental desings in humans.
- Practical application of quantitative methodology.
- Theoretical and applied research methodology.
- Writing research protocols.
- Constraints for ethical research.
Teaching and learning activities
Online
|
Master classes: online adaptation (CT) (CP) |
|
Individual tutorials |
|
Group tutorials |
|
Autonomous learning: online adaptation (ML) |
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Case Method: Online Adaptation (EC) |
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Cooperative learning: online adaptation (RP) |
|
Project-based methodology: online adaptation (PBL) |
Evaluation systems and criteria
Online
|
1 |
Continuous assessment: online adaptation (GP) |
Minimum weighting |
10% |
Maximum weighting |
20% |
|
2 |
Written work: online adaptation (PT) |
Minimum weighting |
40% |
Maximum weighting |
60% |
|
3 |
Oral presentation: online adaptation (GP) |
Minimum weighting |
10% |
Maximum weighting |
20% |
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/