Clinical Trials I

Recommended Prerequisites

All courses taught in the 1st, 2nd and 3rd years of the LFB are important for the understanding of matter taught in class. Students must have English language skills. Língua.

Teaching Methods

Each topic is explained in lectures the masterful type , but with great interaction with students . The evaluation was conducted at the end of the semester, through final exam for the theoretical part . The attendance at lectures is optional but there will be appreciation of the presence and collaboration ( continuous assessment) . Attendance to practical classes is compulsory , students must attend at least 2/3 of lectured. Each topic is explained in practical classes and an application of theoretical concepts .

Learning Outcomes

It is expected that the end of the school students master fundamental principles of clinical trials, in particular refers to its safety and efficacy profile. They should also acquire skills necessary for critical assessment regarding the underlying regulatory component to this type of testing. At the end of the semester the student must have:

Knowledge: Knowing the fundamental characteristics for a clinical trial can be considered robust. You must be able to describe an exploratory, explanatory or pragmatic clinical trial. You should know how to make monitoring a clinical trial.

Skills: Must have critical thinking about the publications of clinical trials. You should be able to apply the various scales for analysis of a clinical trial.

Attitudes: Information Research leading to use, an adequate form, individually or in groups, all the human and technological resources available for learning in this area.

Work Placement(s)

No

Syllabus

Pharmacological rationale and clinical trials. Clinical research. R & D. Development of a medicament.

Type of procedures for marketing authorization. Adverse reactions; Pharmacovigilance.

Ethics and clinical studies. Placebo question. "Investigational medicinal product circuit".

Sources / standards (guidelines) for clinical trials; CONSORT. Legislation.

Phase I clinical trials, II, III and IV. Testing of non-inferiority, equivalence and superiority, bioequivalence.

Good Clinics Practices. Registration of a clinical trial.

Logistics and human conditions for a clinical trial; a trial site.

Development of a clinical trial. Good clinical practice.

The investigator's brochure: rules to follow Experimental medicine.

Rights and duties of those responsible for conducting the test and obligations of participants.

Monitoring a clinical trial.

Head Lecturer(s)

Carlos Miguel Costa Alves

Assessment Methods

Assessment
Synthesis work: 25.0%
Exam: 75.0%

Bibliography

Fundamentals of Clinical Trials; Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger; 2015; https://doi.org/10.1007/978-3-319-18539-2

European Medicines Agency; ICH E6 (R2) Good clinical practice - Scientific guideline; https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice-scientific-guideline

Butcher NJ, Monsour A, Mew EJ, Chan AW, Moher D, Mayo-Wilson E, Terwee CB, Chee-A-Tow A, Baba A, Gavin F, Grimshaw JM, Kelly LE, Saeed L, Thabane L, Askie L, Smith M, Farid-Kapadia M, Williamson PR, Szatmari P, Tugwell P, Golub RM, Monga S, Vohra S, Marlin S, Ungar WJ, Offringa M. Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension. JAMA. 2022;328(22):2252-2264.