Universitat Internacional de Catalunya
Design and Monitoring of Clinical Trials
Other languages of instruction: English, Spanish
Teaching staff
Dra. Andrea Miranda (coord.): aemiranda@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
- 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.
- 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,
- CE8 - To know how to assess research projects and protocols
- CE9 - To know how to apply specific theoretical and practical knowledge to health science research.
- CG1 - The ability to incorporate new knowledge acquired through research and study and cope with complexity.
- CG2 - The ability to critically analyse and discuss research results and transmit the relevant outcomes.
- CG3 - The ability to draw up research questions and put them into operation as research projects and formulate evidence-based research hypotheses.
- 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.
Learning outcomes of the subject
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.
- Theoretical and applied research methodology.
- Writing research protocols.
- Constraints for ethical research.
Teaching and learning activities
In person
Te course will be developed in theoretic and applied sessions with teacher presentations and practical cases.
In each class we will debate on topics and real cases the students will have to have read before the session.
Assessment will be conducted based on a clincial trial protocol developed in groups (3-4 students), which will weight 80% of the final grade (60% written protocol, 20% oral presentation and questions about the protocol).
Individually, students will present a clinical trial of their choice, commenting relevant aspects which will be discussed in the classroom (20%).
Evaluation systems and criteria
In person
Continuous assessment (60%):
1) Group or individual exercises will be develope during and after the class based on the information from the sessions and the data from the compulsory readings (40%).
2) Participation: students are expected to participate actively and dynamically in the classroom. In this section, the contributions for the discussion of the mandatory readings will be taken into account, as well as those generating debate (20%).
Final evaluation (40%):
Will be based on one of the following options, to be chosen by the students:
a) Proposal for an individual clinical trial protocol
or
b) Final exam with multiple choice and short answer questions.
The delivery of the group or individual exercises will be done through Moodle. Not any work will be received by email. In case of taking a final exam, it will be in face-to-face format.
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/