Important notice
The course guide is provisional.
The PDF version of the course guide may take a few days to become available in the DDD.
Research Into Clinical Pharmacology
Code: 42151Credits: 10
| Degree programme | Type | Course |
|---|---|---|
| Applied Clinical Research in Health Sciences | OP | 0 |
Contact lecturer
- Name :
- Rosa María Antonijoan Arbos
- Email :
- rosamaria.antonijoan@uab.cat
Teaching staff
- Maria Antonieta Agusti Escasany
- Magí Farre Albaladejo
- null
- Ignacio José Gich Saladich
- Rosa Maria Morros Pedros
- Maria Cristina Vedia Urgell
- Caridad Pontes Garcia
- Clara Perez Maña
- Claudia Erika Delgado Espinoza
- Maria Gloria Cereza Garcia
Teaching staff (external to UAB)
- M. Sabaté
- S. Grau
Group languages
You can consult this information at the end of the document.
Prerequisites
Basic knowledge of statistics and pharmacological methods can help to understand the subject taught in this module
Objectives
To apply the basic pharmacologic and methodological knowledge to develop clinical research of drugs and interpret the results.
To apply the basic pharmacological and methodological knowledge to carry out a critical analysis of clinical research.
Learning outcomes
- Develop self-learning skills and motivation to continue their education at the graduate level.
- Act respecting the ethical and legal aspects of research and professional activities.
- Develop scientific knowledge, critical thinking and creativity.
- Transferring the results of clinical research in decision-making to the drug therapy.
- Planning, designing and interpreting clinical drug trials.
- Planning, designing and interpreting clinical-epidemiological studies: pharmacovigilance and drug use,
- Plan, design and interpret studies of drug-economy.
- Apply and interpret multivariate statistical techniques, different regression models and analysis of repeated measures designs.
- Recognize and apply ethical and quality requirements to conduct clinical research with drugs.
Contents
A) methodological aspects: The controlled clinical trial and elements in the design of an essay. Evaluation of results and economic evaluation. Clinical trials and Clinical practice: meta-analysis, Cochrane collaboration. Medicine based on tests and applicability in clinical practice. Planning and development of a clinical trial. Clinical trial Protocol. Researcher's Handbook. Methods of gathering information. Quality of measurement. Data collection notebook (CRF). Standardised working procedures (NWPs). Clinical trial monitoring. Study documentation. Audits and inspections. Data management. Medical writting.
b) The adverse effects of medicines and pharmacovigilance: the need for pharmacovigilance and application methods. Systems of notification of adverse reactions: data of spontaneous notification, national and international programs. Observational analytical studies in pharmacoepidemiology (cohorts, cases and controls, metaanalysis). Other strategies for evaluating adverse effects. Evaluation of the benefit/risk ratio. Pharmacovigilance and agents involved (regulators). Definition and classification of studies on drug use. Consumption studies. Quantitative and qualitative evaluation of medicines. Study of process variables: indications, therapeutic schema and factors that condition the use of medicines. Intervention studies. Pharmaceutical policy (regulators, industry and international organizations).
c) Basic type of study of economic evaluation: minimization of costs, cost-benefit, cost-effectiveness and cost-usefulness. Methodological Elements In the study of economic evaluation. Interpretation of studies of economic evaluation of medicines.
d) Research limitations on the clinical impact. Medicine based on evidence and critical evaluation of medical publications. Instruments that facilitate the clinical application of research results (meta-analysis, clinical practice guidelines, systematic reviews). Clinical Practice guidelines: Methodology and qualityassessment. Critical evaluation of the observational research on safety and efficacy.
e) Protection of the rights of the patient. International ethical Codes. Ceics. Legislation: autonomic, national and supranational. Regulatory agencies. Good clinical practice. The National normative Evolution: The new law of biomedical investigation.
f) Reference population and sample. Hypothesis and error. Multivariate analysis. Regression analysis. Survival analysis. Linear and generalized Models. Analysis of repeated measures.
Learning activities and methodology
| Title | Hours | ECTS | Learning outcomes |
|---|---|---|---|
| Theory | 17.5 | 0.7 | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| study, realization of tasks | 138 | 5.52 | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| Practice in class | 40 | 1.6 | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| interactive resolution of clinical cases | 13 | 0.52 | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| unescheduled tutoring | 3 | 0.12 | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| Tasks review | 24 | 0.96 | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| clinical cases seminars | 12 | 0.48 | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
The teaching methodology used in the different training activities of the module includes master classes, design of clinical studies and group discussion of the same during practical seminars, as well as practices on critical reading of published studies and Strengthening a critical attitude towards the information available in order to enhance skills and willingness to research.
The grade of the module is the arithmetic mean of the notes of the materials that compose it.
Assessment
Continuous assessment activities
| Title | Weight | Hours | ECTS | Learning outcomes |
|---|---|---|---|---|
| attendancy and participation | 35% | 0 | 0 | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| Test. Written questionaire | 25% | 1 | 0.04 | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| Work presentation | 40% | 1.5 | 0.06 | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
The qualification of the module is the arithmetic mean of the marks of the materials that compose it.
Students who do not take both the theoretical and practical assessment tests will be considered \"Not Evaluable\", exhausting their rights to enroll in the subject.
The commission of any irregularity in an assessment activity (academic fraud, plagiarism, or improper use of AI, unless such use is expressly authorized in the course guide) that may lead to a significant alteration of the grade will result in that assessment activity being graded as 0.If the course guide stipulates that obtaining a minimum grade in that assessment activity is an essential requirement for passing the course, or if multiple irregularities occur in the assessment activities of the same course, the final grade for the course will be 0.
Furthermore, disciplinary proceedings may be initiated against any student who commits any of these irregularities.
This subject/module does not provide for the single assessment system
Bibliography
Bibliographic searchs:
- www.pubmed.org
- www.sietes.org
Text books:
- Laporte JR. Principios básicos de investigación clínica. Acceso on-line gratuito:
http://www.icf.uab.cat/ca/productes/publi/subllibres/pbic.html
- Laporte JR, Tognoni G. Principios de epidemiología del medicamento. Acceso gratuito:
http://www.icf.uab.cat/ca/productes/publi/subllibres/pem.html
- Figueras A, Narváez E, Vallano A. Estudios de utilización de medicamentos. Acceso gratuito:
http://www.icf.uab.cat/ca/productes/publi/subllibres/eum_man.html
- Diogène E. Guía de investigación clínica para la atención primaria. Ediciones Mayo, Barcelona 2005.
- The AGREE Research Group. Instrumento AGREE, 2009
Software
Teams
Course groups and languages
The information provided is provisional until November 30. After this date, you will be able to consult the language of each group through this link. To access the information, you will need to enter the course CODE