ECTS credits ECTS credits: 3
ECTS Hours Rules/Memories Student's work ECTS: 51 Hours of tutorials: 3 Expository Class: 9 Interactive Classroom: 12 Total: 75
Use languages Spanish, Galician
Type: Ordinary subject Master’s Degree RD 1393/2007 - 822/2021
Departments: Pharmacology, Pharmacy and Pharmaceutical Technology, External department linked to the degrees
Areas: Pharmacology, Área externa M.U en Investigación y Desarrollo de Medicamentos
Center Faculty of Pharmacy
Call: Second Semester
Teaching: With teaching
Enrolment: Enrollable | 1st year (Yes)
1. Describe the principles of evaluating the efficacy, safety and effectiveness of pharmacological treatments.
2. Acquire notions, and as far as possible promote attitudes, on the aspects that support the rational use of medications, such as evaluating their efficacy and safety, by critically reading clinical research studies with medications and analyzing the risks associated with its use.
I.- THE EVALUATION OF EFFECTIVENESS. CLINICAL TRIAL:
1. Experimental methodology for evaluating the effectiveness of medications. Drug development. The clinical trial.
2. Clinical trial (I): Phases. Assessment of the response. Main and secondary variables.
3. Clinical trial (II): Types of design. Clinical trials in parallel, crossover, sequential and factorial groups. Explanatory and pragmatic clinical trials.
4. Clinical trial (III): Study population and sample. Inclusion and exclusion criteria. Internal validity and external validity.
5. Clinical trial (IV): Randomization and masking. Placebo effect.
6. Ethical and legal aspects of the clinical trial.
II. THE EVALUATION AND CONTROL OF THE RISKS OF THE USE OF THE DRUGS:
7. Adverse drug reactions: Factors that condition them. Production mechanisms.
8. Pharmacovigilance. Objectives and strategies. Assessment of causality.
9. Principles of therapeutic drug monitoring.
III.- EVALUATION OF THE EFFECTIVENESS. SELECTION OF MEDICINES:
10. Literature assessment criteria. Systematic reviews. Meta-analysis.
11. Risk benefit assessment: Evaluation of effectiveness. Evidence based medicine.
12. Criteria for drug selection.
- Blass B. Basic Principles of Drug Discovery and Development. edition 3. Academic Press. ISBN: ISBN: 9780443157479 (2025).
- Biswal S, Jose VM. An An Overview of Clinical Trial Operations: Fundamentals of clinical trial planning and management in drug development. Biswal S y Jose VM eds. ISBN: 979-8310947191 (2025)
- Tato Herrero, F. Bases metodológicas de la investigación clínica con medicamentos.© Fernando Tato Herrero. Rexistro dos dereitos dea Propiedade intelectual: Núm. de Asento Rexistral, 03/2016/436 (pendente de publicación).
- Ensayos Clínicos en España: Actualización en ética, normativa, metodología y nuevas tecnologías. Coordinadora: Concepción Martínez Nieto. SEFH (Sociedad Española de Farmacia Hospitalaria) & Merck. Mayo de 2017. ISBN: 978-84-697-3116-1 (https://www.sefh.es/bibliotecavirtual/ensayos/Ensayos_clinicos.pdf).
- Rick NG. Drugs: From Discovery to Approval, 3 edición. Wiley-Blackwell. ISBN: 978-1118907276 (2015).
- Real Decreto 1090/2015, do 4 de decembro, polo que se regulan os ensaios clínicos con medicamentos, os Comités de Ética da Investigación con medicamentos e o Rexistro Español de Estudos Clínicos.
- Real Decreto Lexislativo 1/2015, do 24 de xullo, polo que se aproba o texto refundido da Lei de garantías e uso racional dos medicamentos e producto sanitarios.
- Regulamento (UE) Non 536/2014 Do Parlamento Europeo e do Consello do 16 de abril de 2014 sobre os ensaios clínicos de medicamentos de uso humano, e polo que se derroga a Directiva 2001/20/CE.
- Documento de instrucións da Axencia Española de Medicamentos e Produtos Sanitarios para a realización de ensaios clínicos en España.
- Contidos relacionados nas seguintes direccións web:
- https://www.aemps.gob.es
- https://www.ema.europa.eu/en
- https://www.fda.gov/drugs
- Proxecto Best. Plataforma Tecnolóxica Española de Medicamentos Innovadores (https://www.medicamentos-innovadores.org).
- Bases de datos, motores de procura e índices temáticos relacionados coas Ciencias da Saúde.
- Servizo de EZproxy que permite o acceso a recursos electrónicos subscritos por BUSC e os subscritos a través do Consorcio BUGALICIA, para todos os membros da comunidade universitaria.
Learning outcomes and competencies:
• Understand the principles of evaluating the efficacy, safety, and effectiveness of pharmacological treatments: CB7, CB10, CG3, CG5, CG6, CG7, CG9, CG10, CG11, CE2, CE3, CE6, CE9, CE10, CE11, CE12, CE13, CE14, CE15.
• Understand the stages of clinical research: CB6, CB7, CB8, CB9, CB10, CG1, CG3, CG4, CG5, CG6, CG7, CG8, CG9, CG10, CE1, CE2, CE3, CE4, CE5, CE6, CE7, CE9, CE10, CE11, CE12, CE13, CE14, CE15.
• Understand the stages of clinical research: CB6, CB7, CB8, CB9, CB10, CG1, CG3, CG4, CG5, CG6, CG7, CG8, CG9, CG10, CE1, CE2, CE3, CE4, CE5, CE6, CE7, CE9, CE10, CE11, CE12, CE13, CE14, CE15.
• Understand a clinical trial's ethical and legal aspects: CB7, CB8, CB10, CG6, CG9, CG11, CE1, CE2, CE9, CE12, CE13.
• Understand the basics of the pharmacovigilance system: CB7, CB8, CB10, CG3, CG5, CG6, CG7, CG9, CG10, CG11, CE2, CE4, CE6, CE9, CE10, CE11, CE12, CE13, CE14, CE15.
• Become aware of the need for rational drug use: CB7, CB8, CB10, CG3, CG5, CG6, CG7, CG9, CG10, CG11, CE1, CE6, CE9, CE10, CE12, CE13, CE14.
• Critically read scientific articles on clinical research: CB6, CB7, CB8, CB9, CB10, CG1, CG2, CG3, CG4, CG5, CG6, CG7, CG8, CG9, CG10, CG11, CE1, CE2, CE3, CE4, CE5, CE6, CE9, CE10, CE11, CE12, CE13, CE14, CE15.
• Explore career opportunities in Clinical Drug Development: CB10, CG6, CG8, CG9, CG10, CG11, CE1, CE2, CE3, CE4, CE5, CE6, CE7, CE9, CE10, CE11, CE12, CE13, CE14, CE15.
It is based on the exposition of topics of a theoretical nature and the holding of seminars, the contents of which are interrelated, seeking to provide a vision of the set of knowledge and skills that a professional must possess for solving problems in a real work environment.
• Attendance and participation: 80%. Approved skills: CB6, CB7, CB8, CB9, CB10, CG1, CG2, CG3, CG4, CG5, CG6, CG7, CG8, CG9, CG10, CG11, CE1, CE2, CE3, CE4, CE5, CE6, CE7, CE9, CE10, CE11, CE12, CE13, CE14, CE15.
• Individual memory: 20%. Approved skills: CB6, CB7, CB8, CB9, CB10, CG1, CG2, CG3, CG4, CG5, CG6, CG7, CG8, CG9, CG10, CG11, CE1, CE2, CE3, CE4, CE5, CE6, CE7, CE9, CE10, CE11, CE12, CE13, CE14, CE15.
Theory: 12 hours in person + 24 hours of student personal work
Seminars: 8 hours in person + 29 hours of student personal work
Assessment: 2 hours in person
TOTAL: 22 hours in person + 53 h personal work of the student = 75 total hours
- The active participation of the student in the proposed activities is recommended.
- Likewise, it is important the handling of the recommended bibliography for the subject by the student.
- You must have a basic knowledge of English and computers.
Ma Del Pilar Fernandez Rodriguez
- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacology
- Phone
- 881812401
- mdelpilar.fernandez [at] usc.es
- Category
- Professor: University Lecturer
Manuel Freire-Garabal Nuñez
Coordinador/a- Department
- Pharmacology, Pharmacy and Pharmaceutical Technology
- Area
- Pharmacology
- Phone
- 881812248
- manuel.freire-garabal [at] usc.es
- Category
- Professor: University Professor
| Monday | |||
|---|---|---|---|
| 16:30-17:30 | Grupo /CLE_01 | Spanish | 5035 Pharmacology Seminar Room |
| 17:30-18:30 | Grupo /CLE_01 | Spanish | 5035 Pharmacology Seminar Room |
| 18:30-19:30 | Grupo /CLIS_01 | Spanish | 5035 Pharmacology Seminar Room |
| Tuesday | |||
| 16:30-17:30 | Grupo /CLE_01 | Spanish | 5035 Pharmacology Seminar Room |
| 17:30-18:30 | Grupo /CLE_01 | Spanish | 5035 Pharmacology Seminar Room |
| 18:30-19:30 | Grupo /CLIS_01 | Spanish | 5035 Pharmacology Seminar Room |
| Wednesday | |||
| 16:30-17:30 | Grupo /CLE_01 | Spanish | 5035 Pharmacology Seminar Room |
| 17:30-18:30 | Grupo /CLIS_01 | Spanish | 5035 Pharmacology Seminar Room |
| 18:30-19:30 | Grupo /CLIS_01 | Spanish | 5035 Pharmacology Seminar Room |
| Thursday | |||
| 16:30-17:30 | Grupo /CLE_01 | Spanish | 5035 Pharmacology Seminar Room |
| 17:30-18:30 | Grupo /CLIS_01 | Spanish | 5035 Pharmacology Seminar Room |
| 18:30-19:30 | Grupo /CLIS_01 | Spanish | 5035 Pharmacology Seminar Room |
| Friday | |||
| 16:30-17:30 | Grupo /CLE_01 | Spanish | 5035 Pharmacology Seminar Room |
| 17:30-18:30 | Grupo /CLIS_01 | Spanish | 5035 Pharmacology Seminar Room |
| 18:30-19:30 | Grupo /CLIS_01 | Spanish | 5035 Pharmacology Seminar Room |