Català Castellano
DEGREE CURRICULUM
CLINICAL TRIALS: DESIGN AND MANAGEMENT
Coordination:
GOMEZ ARBONES, XAVIER
Academic year 2017-18
DEGREE CURRICULUM: CLINICAL TRIALS: DESIGN AND MANA... 2017-18

Subject's general information
Subject nameCLINICAL TRIALS: DESIGN AND MANAGEMENT
Code14702
Semester1st Q(SEMESTER) CONTINUED EVALUATION
Typology
DegreeCourseTypologyModality
Master's Degree in Biomedical Research1COMMONAttendance-based
ECTS credits4
Groups1GG
Theoretical credits2.4
Practical credits1.6
CoordinationGOMEZ ARBONES, XAVIER
DepartmentCIENCIES MEDIQUES BASIQUES,INFERMERIA I FISIOTERÀPIA,MEDICINA,MEDICINA EXPERIMENTAL
Teaching load distribution between lectures and independent student workEach credit is calculated as 25 hours of work: 10 hours of lectures and 15 hours of independent study by the students.
Important information on data processingConsult this link for more information.
LanguageCatalan (70%), Spanish (10%) and English (20%; documentation)
Distribution of creditsTotal: 4 ECTS
- Lectures: 1.2 ECTS
- Practices: 1.6 ECTS
- Seminars: 1.2 ECTS
Office and hour of attentionTelèfon: 973702208
Correu: xga@medicina.udl.cat
Ubicació del Despatx: 1.04. Unitat Docent Facultat de Medicina. Hospital Universitari Arnau de Vilanova
Teaching staffE-mail addressesCredits taught by teacherOffice and hour of attention
GOMEZ ARBONES, XAVIERxga@medicina.udl.cat2,4
SANCHEZ DE LA TORRE, MANUELsanchezdelatorre@cmb.udl.cat,4
SCHOENENBERGER ARNAIZ, JUAN ANTONIOshoenenberger@mex.udl.cat1
ZAPATA ROJAS, AMALIAamalia.zapata@infermeria.udl.cat,1
Subject's extra information

Guest lecturers: Susana Peñuelas , Laura Rumi, Maria Ruiz, Montse Solanillas, Francesc Verges and Amalia Zapata.

Students who approve this matter will:

    Know the fundamental principles of bioethics and clinical research.
    Know the rules on human research, especially related to clinical trials.
    Be able to propose, design, analyze, monitor and evaluate clinical research studies.

Students will visit the Biobank of IRBLL

Students must attend and participate in a meeting of the Ethics Committee of HUAV Lleida.

Students must sign a commitment to respect the confidentiality of the information that will have access in accordance with "Llei 15/1999, de protecció de dades de caràcter personal", and "Decret 406/2006, de 24 d’octubre, d’acreditació de comitès ètics d’investigació clínica".

Learning objectives

The objectives of the course are:

     Learn the basic principles of bioethics and clinical research.
     Know the legal regulations related to biomedical research.
     Know the different types of research studies.
     Be able to design and manage a clinical trial protocol and other projects.
     Be able to evaluate clinical trial protocols (methodology, ethical and legal issues, informed consent, confidentiality)
     Know the procedures for monitoring clinical trials.
     Attend a meetings of the Ethics Committee of the Hospital Arnau de Vilanova of Lleida
     Participate in clinical research projects of the Biomedical Research Institute of Lleida

Competences

Specific skills:

     Be able to design, monitor and evaluate protocols for clinical trials.
     Other specific skills:
         Understand the fundamental principles of bioethics and clinical research
         Kown the main legislation on human research, especially related to clinical trials
         Be able to design, execute and analyse research studies and protocols (especially clinical trials).
         Qualification for the evaluation of clinical trials.
         Be prepared to do monitoring and coordination of clinical trials.
          In short, be able to propose, design, analyze, monitor and evaluate clinical research studies.

Subject contents

Contents (classroom sessions)

    Introduction to different types of projects. Clinical trials.
    Clinical and EBM. Role of research and clinical trials
    Introduction to methodological and ethical aspects of clinical trials
    Clinical trials. Results and importance in decision-making in health.
    Regulations and legal issues in clinical trials.
    CEIC. .
    Methodological and statistical aspects of clinical trials
    Units and structures for supporting research and clinical trials
    Clinical trials and research projects. Perspective of the researcher I
    Clinical trials and research projects. Perspective of the researcher II
    Clinical trials and research projects. Perspective of industry
    Product management research in the context of clinical trials (1h class). Monitoring research (1h class)
    Assays based on records.
    Evaluation proojects I
    Evaluation projects II
    Biobank (storage and custody of samples) (1h class). Informed consent (1h class)
    Quality Assurance
    Final session.

Other sessions

    Practice at the Biobank
    Evaluation of projects for CEIC.
    CEIC guest assistance (in small groups).

 

 

 

 

Methodology

The methodology of the course is based on the following activities:

     Master classes about the program contents
     Seminars and group work.
     Attendance at scientific conferences of guest lecturers
     Individual and group work (resolution of problems and activities)
     Work on a clinical trial protocol.
     Evaluation of clinical trial protocols
     Attendance at meetings of the CEIC
     Visit a biobank
     Participation in research projects
     Tutoring by teachers
     Oral presentations

Development plan

Dateilebn cronogram in the catalan guide
 

Evaluation

The evaluations is based on:

     Continuous assessment of attendance and class participation (lectures, seminars and group work).
     Practical work and resolution of activities.
     Exam (of all learning activities).

The first day we will deal about the conditions of the student evaluation.

Bibliography

Basic::

  1. Hulley SB, Cummings SR. Diseño de la investigación clínica. Un enfoque epidemiológico. Ediciones Doyma. Barcelona, 1993.
  2. Argimón Pallás JM, Jiménez Villa J. Métodos de investigación aplicados a la atención primaria. Mosby/Doyma. Barcelona, 1994.
  3. Armitage P, Berry G. Estadística para la investigación biomédica. Ediciones Doyma. Barcelona, 1992.
  4. Abella F, Fajó M, Gómez X, March J, Sorribas A. Metodología estadística en ciencias de la salud. Del diseño del estudio al análisis de los resultados. Edicions de la UdL y F.V. Libros Eines 26, 2001.
  5. Evaluación de Ensayos Clínicos. Inés Galende. Fundación AstaZeneca. Madrid, 2006.
  6. Evaluación de Protocolos de Investigación Biomédica. Inés Galende. Fundación AstaZeneca. Madrid, 2007.
  7. Guía para los Miembros de los Comités de Ética de Investigación. El Comité Director de la Bioética. Consejo de Europa, enero 2012.
  8. Aspectos éticos y jurídicos a tener en cuenta en los estudios clínicos en Fase II y III. Juan Canimas. Publicacions de la Càtedra de Promoció de la Salut. Documenta Universitària. 2013

Web resources:

  1. Asociación Nacional de Miembros de Comités de ética de la Investigación: ancei.es
  2. ClinicalTrials. Registre d'assaigs clínics de la Biblioteca Nacional de Medicina dels Estats Units: clinicaltrials.gov
  3. EudraCT. Base de dades que registre tots els assaig clínics  a la Unió Europea: eudract.ema.europa.eu
  4. Web de Agencia Española de Medicamentos y Productos Sanitarios: www.aemps.gob.es

 

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