Clinical Trialing of Medicines

(1) Define the concept of clinical trials and describe their role in the development of new drugs;
(2) Apply the principles of bioethics to the conduct of human research.
(3) Identify potential biases and fallacies in clinical research and propose strategies to avoid them.
(4) Select the most appropriate type of clinical trial design for each specific case.
(5) Assess the limitations of the applicability of clinical trials to clinical practice.
(6) Critically read clinical trials.
(7) Develop a clinical trial protocol.

Block 1: Concept, ethical and legal aspects.
Introduction to the Clinical Trial. Concept, historical evolution.
2. Legal and regulatory environment: functions of regulatory agencies (FDA, EMA).
3. Ethical aspects of clinical trials, European and national regulations, clinical research ethics committees.
4. Phases in the pre-clinical and clinical stage of drug development.

Block 2: Trial design
5. The research question, study population, study groups.
6. Measurement of patient response, sample size, randomisation.
7. Masking, analysis plan, interpretation of the results.

Block 3: Types of trials
8. Parallel, crossover and sequential trials.
9. Factorial, cluster, pragmatic, pragmatic clinical trials, non-inferiority studies, post-authorisation studies.
10. Educational, vaccine and other trials.

Block 4: Practical aspects
11. Setting up, conducting, organising and registering clinical trials.
12. Monitoring and management of clinical trials.

- Bakke OM, Carné X, García F. Ensayos clínicos con medicamentos. Fundamentos básicos, metodología y práctica. Barcelona: Doyma, 2004.

- Martinez Nieto, C. Ensayos Clínicos en España. Ética, normativa, metodología y aspectos prácticos. Madrid: Master Line & Prodigio, 2010 (libre acceso en el aula virtual)

- Dal-Re, R, Carné, X, Gracia, D. Luces y sombras en la investigación clínica. Madrid: Triacastela; Fundació Víctor Grífols I Lucas, 2013. (libre acceso en el aula virtual)

KNOWLEDGE

Con 01. Knowing the origin, nature, and how to design, obtain, analyse, control and produce active ingredients, drugs and medicines, as well as other products and raw materials of health interest for human or veterinary use.
Con 02. Knowing the therapeutic and toxic effects of substances with pharmacological activity.
Con 03. Know how to apply the scientific method and acquire skills in the handling of legislation, sources of information, bibliography, preparation of protocols and other aspects considered necessary for the design and critical evaluation of pre-clinical and clinical trials.
Con 05. Acquire knowledge in pharmacotherapy and diet therapy, as well as in the nutritional and food area in the establishments in which they provide services.
Con 06. Acquire basic knowledge in clinical management, health economics and efficient use of health resources to promote the rational use of medicines and health products.
Con 07. Knowing, evaluating and assessing problems related to drugs and medicines, as well as participating in pharmacovigilance activities.
Con 08. Knowing the activities of clinical and social pharmacy, following the pharmaceutical care cycle.
Con 09. Knowing the ethical and deontological principles according to the legislative, regulatory and administrative provisions governing professional practice, understanding the ethical implications of health in a changing social context.
Know one's own limitations and the need to maintain and update professional competence, giving special importance to self-learning of new knowledge based on the available scientific evidence.
Con 33. Know the effects of substances with pharmacological activity.
Con 34. Know and understand the techniques used in the design and evaluation of pre-clinical and clinical trials.
Con 35. Knowing the relationship between food and health, and the importance of diet in the treatment and prevention of disease.
Con 36. Know the management and characteristics of pharmaceutical care in the healthcare structures of Primary Care and Specialised Care in the Health System.
Knowing the structure and function of the human body, as well as the general mechanisms of disease, molecular, structural and functional alterations, syndromic expression and therapeutic tools to restore health.
Con 38. Knowing the nature, mechanism of action and effect of toxins, as well as resources in case of poisoning.
Con 39. Knowing the analytical techniques related to laboratory diagnosis, toxics, food and environment.
Con 40. Knowing the management and characteristics of pharmaceutical care in the office environment and the pharmaceutical industry.
Con 42. Knowing and applying the legal, social and economic conditions related to the health field and in particular with the drug.
Con 43. Knowing information retrieval techniques related to primary and secondary information sources (including databases with the use of computers).
Con 44. Know the ethical and deontological principles and act according to the legislative, regulatory and administrative provisions governing professional practice, collaborating with other health professionals and acquiring teamwork skills.
Con 45. Know and apply management techniques in all aspects of pharmaceutical activities.
Con 46. Knowing the principles and scientific methodology applied to pharmaceutical sciences, including the history and social function of Pharmacy.
Con 47. Acquire basic knowledge of the National Health System, of health legislation in general and specifically that related to medicines, health products and pharmaceutical care.
Con 48. Knowing the oral and written communication techniques that allow informing users of pharmaceutical establishments in intelligible terms and appropriate to the different cultural levels and social environments.
Con 49. Knowing the operation and management of a hospital or primary care pharmacy service, including the staff assigned to them.


SKILLS or ABILITIES

H/D 05. Develop communication and information skills, both oral and written, to deal with patients and users of the centre where he/she carries out his/her professional activity.
H/D 06. Promote work and collaboration skills in multidisciplinary teams and those related to other health professionals.
Apply knowledge of physics and mathematics to pharmaceutical sciences.
Apply computational and data processing techniques in relation to information concerning physical, chemical and biological data.
Promote the rational use of medicines and medical devices.
Provide therapeutic advice on pharmacotherapy and diet therapy, as well as nutritional and dietary advice to users of the establishments in which they provide services.
H/D 26. Carry out pharmacovigilance.
H/D 28. Make correct use of scientific information sources, including those in English.
H/D 29. Analyse and synthesise basic information in both Spanish and English and summarise it correctly and intelligibly.
H/D 30. Structure, develop and summarise a paper on a specific aspect of the profession.
H/D 31. Orally present clearly and synthetically a report on a general or specific aspect of the profession and defend it publicly.

- Lecture classes in large groups: Lecture given by the lecturer The lecturer will be supported by audiovisual and computer media. These classes will usually follow the contents of the reference manual.

- Interactive classes in small groups: Theoretical/practical class in which applications of the theory, problems, exercises, etc. are proposed and solved. The student will actively participate in these classes in different ways: solving exercises in the classroom, etc.

- Tutorials in very small groups: Supervised work, clarification of doubts about theory or practices, problems, exercises, readings or other proposed tasks will be supervised, as well as the presentation, exhibition, debate or commentary of individual work or work done in small groups.

The assessment of the knowledge, skills and competences acquired in the subject will be carried out in the following ways:

Continuous assessment (2 points. In order to obtain the 2 points, a minimum seminar attendance of 75% is required).

- Assessment of the resolution of practical cases and problems/exercises presented and/or handed in, oral presentation (1.5 points).
- Knowledge assessed: 01-03; 05-10; 33-40; 42-49
- Skills assessed: 05-06; 10-11; 18-19; 26; 28-31
- Attitude and participation in the programmed activities, and of reasoned individual resolution of questions and problems in the classroom (0.5 points).

Written exam (8 points): Resolution of a practical case study.
- In order for this mark to be added to the continuous assessment mark, a score of at least 3.5 points must be obtained.
- Knowledge assessed: 01-03; 05-10; 33-40; 42-49
- Skills assessed: 05; 10-11; 18-19; 26; 29-30

Individual or group self-study: 30h
Resolution of exercises, or other work: 27h
Guidance and resolution of doubts: 3h
Elaboration, presentation and exposition: 3h
Completion and revision of the exam: 4,5

Total hours of personal work 67,5

Class attendance is important, together with continuous study of the subject, since in this discipline knowledge of one subject is necessary to understand the following ones.

The degree to which students understand the subject, their ability to solve problems, and their critical spirit will be assessed.