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: Psychiatry, Radiology, Public Health, Nursing and Medicine
Areas: Preventive Medicine and Public Health
Center Faculty of Medicine and Dentistry
Call: Second Semester
Teaching: With teaching
Enrolment: Enrollable | 1st year (Yes)
• Define the concept of a clinical trial and describe its role in the development of new pharmaceutical drugs.
• Apply the principles of bioethics to conducting research in humans.
• Identify the possible biases and fallacies of clinical research and propose strategies to avoid them.
• Select the most appropriate type of clinical trial design for each specific case.
• Assess the limitations of the applicability of clinical trials to clinical practice.
1. Introduction to clinical trials. Concept, historical evolution.
2. Ethical considerations: Informed consent, common good against the rights of individuals, limits of what is ethically acceptable. Groups that require special protection. Ethics committees.
3. Research and development of new pharmaceutical drugs. Clinical needs and therapeutic innovation. Compounds with therapeutic potential: phases of their development.
4. Fundamentals of Clinical Trials (CT). Control group, randomization, masking.
5. Parallel-controlled clinical trials. Calculation of the measures of effect.
6. Crossover clinical trials. Fundamentals, advantages and limitations.
7. Sequential clinical trials. Fundamentals, advantages and limitations.
8. Factorial clinical trials. Fundamentals, advantages and limitations.
9. Measurement of the evolution of the patient's response: Pharmacological action against therapeutic effect. Sources of data. Measurement of subjective variables.
10. Explanatory clinical trials and pragmatic trials
11. Elaboration of a protocol of a CT. Justification, objectives, study subjects and method.
Basic
• Bakke OM, Carné X, García Alonso F. Clinical drug trials. Barcelona: Doyma; 1994
Complementary bibliography
• Bonfill X, Porta Serra M. Is a control group necessary? Med Clin (Barc) 1987; 89: 429-35.
• Figueiras A. Epidemiology: General concepts. Madrid: Spanish Society of Medicine and Safety at Work (OMC Formación); 2001
• Galende I, Sacristán JA, Soto J. How to improve the quality of clinical trials. Med Clin (Barc) 1994; 102: 465-70.
• García-Alonso F, Guallar E, Bakke OM, Card X. Placebo in clinical drug trials. Med Clin (Barc) 1997; 109: 797-801
• Grace D. Between clinical trial and clinical ethics: good clinical practice. Med Clin (Barc) 1993; 100: 333-336.
• Porta M, Ibáñez Ll, Carné X, Laporte JR. Principles of the clinical trial. Med Clin (Barc) 1983; 80: 768-71.
• Rodríguez Artalejo F, Rey Calero J, Alegre del Rey E, Villar Álvarez F. Experimental studies. In: Gálvez Vargas R, Sierra López A, Sáenz López MC, et al, editors. Piédrola Gil. Preventive Medicine and Public Health. 10th ed. Barcelona: Masson; 2000
• Tato F, Figueiras A, Rodríguez C. Methodological bases of Clinical Trial. Santiago de Compostela: Publications Service of the University of Santiago de Compostela; 1998
• Be able to read critically a scientific article of a clinical trial.
• Be able to elaborate a protocol of simple clinical trial.
The course begins with a face-to-face initial class according to the academic calendar. In the rest of the classes, different distance teaching techniques will be used (materials on the web, articles, videos). For this objective, the Moodle platform will be used. Discussion forums will be formed, so that students can interact and discuss among themselves and/or with the professor.
The tutorials may be carried out in person, by email or by videoconference.
The exams, consisting in the critical reading of a scientific work, can be carried out in person or by videoconference, according to the student's preference
Participation in the discussion forums: 20%.
Critical reading of a trial: 80%
30 hours of course follow-up
15 hours of final work
1 hour exam
Asistencia a clase, e participación activa na mesma.
PLAN DE CONTINGENCIA
Ninguno. Se trata de una asignatura online.
Adolfo Figueiras Guzman
Coordinador/a- Department
- Psychiatry, Radiology, Public Health, Nursing and Medicine
- Area
- Preventive Medicine and Public Health
- Phone
- 881812276
- adolfo.figueiras [at] usc.es
- Category
- Professor: University Professor
Juan Miguel Barros Dios
- Department
- Psychiatry, Radiology, Public Health, Nursing and Medicine
- Area
- Preventive Medicine and Public Health
- Phone
- 981950095
- juanm.barros [at] usc.es
- Category
- Professor: University Lecturer