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. Ensayos clínicos con medicamentos. Barcelona: Doyma; 1994.
SUPPLEMENTARY
- Tato Herrero, F. Bases metodológicas de la investigación clínica con medicamentos. 2nd ed. Universidad de Santiago de Compostela; 2015.
- DalRé R, Carné X, Gracia D. (2013). Luces y sombras en la investigación clínica. Triacastela 2013.
- Karlberg, JP, Speers MA. Revisión de ensayos clínicos: una guía para el Comité de ética. Hong Kong: Centro de Ensayos Clínicos, Universidad de Hong Kong; 2010.
- Perlmutter, J. Understanding clinical trial design: A tutorial for research advocates. AdvocateINstiotute.
• Be able to read critically a scientific article of a clinical trial.
• Be able to elaborate a protocol of simple clinical trial.
Initial face-to-face class according to the academic calendar. The rest of the classes will use different distance learning techniques (web-based materials, articles, videos). The Moodle platform will be used for this purpose. Discussion forums will be set up so that students can interact and discuss among themselves and/or with the professor.
Tutorials may be face-to-face, by e-mail or videoconference.
The exams, consisting of the critical reading of a scientific work, can be done in person or by videoconference, according to the student's preference.
CONTINUOUS EVALUATION (30%):
- Participation in discussion forums (25%), and in group tutoring (5%).
FINAL EVALUATION (70%):
- Critical reading of an essay and alternative design proposal: 70%.
NOTE: For cases of fraudulent performance of exercises or tests will apply the rules set out in the Regulations for the evaluation of the academic performance of students and review of qualifications.
30 hours of course follow-up
15 hours of final work
1 hour exam
- Participate actively in the forums, responding regularly to the questions that are raised.
- Participate in the group tutorials in which doubts are exposed and doubts about critical reading and alternative design of the "common" reading are solved.
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
Angel Salgado Barreira
- Department
- Psychiatry, Radiology, Public Health, Nursing and Medicine
- Area
- Preventive Medicine and Public Health
- angel.salgado.barreira [at] usc.es
- Category
- Professor: LOU (Organic Law for Universities) PhD Assistant Professor