Dr. Carlos García Forero (coord.): cgarciaf@uic.es
Introduction
In the event that the health authorities announce a new period of confinement due to the evolution of
the health crisis caused by COVID-19, the teaching staff will promptly communicate how this may effect
the teaching methodologies and activities as well as the assessment.
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.
Competencies
CE4 - To know how to use critical assessment tools for qualitative and quantitative research articles
CE5 - To know how to apply the language of scientific writing when communicating health outcomes
CE6 - To know how to describe and apply the most common techniques for exploring and analysing data, the relationship between variables or categories and/or corroborating hypotheses in both quantitative and qualitative research.
CE7 - To know how to identify health problems on which research may be undertaken and to apply specific techniques to analyse and assess such problems,
CE9 - To know how to apply specific theoretical and practical knowledge to health science research.
CG2 - The ability to critically analyse and discuss research results and transmit the relevant outcomes.
CG4 - The ability to articulate and defend one's own scientific ideas in an ethical way with regard to the research process
CT1 - The ability to integrate within an established, multidisciplinary and multicultural work team.
CB10 - To have the learning competences that allow them to continue to study in a way that will have to be mainly independent.
CE1 - To know how to apply scientific methods, experimental design and biostatistics to answer a question or corroborate a hypothesis in a clinical setting.
CE10 - The ability to critically analyse and discuss research results and transmit the relevant outcomes
CE2 - To know how to design a research project within a specific context in a clinical setting
CE3 - To know how to describe both the quantitative and qualitative methodological designs used in health research in the healthcare environment.
CE8 - To know how to assess research projects and protocols
CG1 - The ability to incorporate new knowledge acquired through research and study and cope with complexity.
CG3 - The ability to draw up research questions and put them into operation as research projects and formulate evidence-based research hypotheses.
Learning outcomes
At the end of the course the student will be able to
Formulating research questions for CTs taking into account the different aspects of its formulation.
Defining define the mos appropriate outcomes and designs for their research question.
Identifying critical study endpoints and assess its fesaibility and adequacy.
Designing and monitoring CTs.
Appraising the mandatory points for ethical designs and development of CTs.
Interpreting and reporting CT results.
Critically reading clinical trials.
Developing research protocols for CTs.
Syllabus
In this course, we will work these contents:
Experimental desings in humans.
Practical application of quantitative methodology.