João De Almeida Lopes da Fonseca
Cristina Isabel Oliveia Jácome
Ana Margarida Barbosa Ribeiro Pereira
Fernanda Inês de Carvalho Pereira Ribeiro
Portuguese – Suitable for English-speaking students
Explain the definition and framework of intervention studies;
Characterize the methodology for designing intervention studies;
Design clinical trials,
Implement clinical trials;
Interpret clinical trial results,
Evaluate clinical trials from an economic point of view;
Discuss the ethical and legal aspects to be considered in the design and implementation of clinical trials;
Write protocols and proposals for the execution of clinical trials;
Discuss the main difficulties resulting from participation as a researcher in clinical trials.
Intervention studies – Definitions and framework;
Design of clinical trials, methodological aspects and structuring of clinical trial protocols – SPIRIT recommendations (Standard Protocol Items: Recommendations for Interventional Trials);
Regulation and legislation
Introduction to the recommendations of the International Conference on Harmonization of technical requirements for the registration of pharmaceutical products for human use (ICH)
Good Clinical Practice
Practical aspects in the execution of a clinical trial.
Quality management.
Organizational, administrative and financial aspects
Presentation of results of intervention studies – CONSORT recommendations (Consolidated Standards of Reporting Trials)
Controversies related to clinical trials
After the theoretical exposition of each topic described for the discipline, there will be the creation of practical working groups and critical analysis and the realization of exercises. Individual study. The discipline will have its evaluation resulting essentially from the realization of a theoretical test and presentation of a work.
Final grade = 0.4 * theoretical test + 0.4 * assignment + 0.2 * face-to-face participation
Frequency participation, submission of written work
Final grade = 0.4 * theoretical test + 0.4 * assignment + 0.2 * face-to-face participation
Distributed evaluation without final exam
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; Consolidated Standards of Reporting Trials Group. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel grouprandomised trials, J Clin Epidemiol. 2010 Aug;63(8):e1-37
Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. S; SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. , BMJ. 2013 Jan 8;346:e7586
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2). 11/2016. (https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf)