Gestão dos processos inerentes à implementação e condução de ensaios clínicos de fase I

Abstract

Over the last few decades there has been a great growth in the area of clinical research, namely in clinical trials. Clinical trials are a set of research procedures conducted in humans, representing an important step in the process of innovation and development of new therapies that can change the course of treatment of many pathologies and make a difference in the lives of many patients. This internship was carried out at BlueClinical, more specifically in the Phase I Unit located at Hospital da Prelada and had as its main objective to enumerate the steps from the pre-trial to the post-trial and characterize the CTA function. This report presents the definition of a clinical trial, its history, the definition of an experimental drug, the stages of drug development, types of trials, benefits and barriers in clinical trials and the status of clinical trials in Portugal. Further on, the company where the curricular internship was carried out, BlueClinical, stands out. Subsequently, the steps for conducting a clinical trial are listed, from the preparation of the clinical trial, through the during, to the after the clinical trial, ending with the main conclusions.

Date of Award	15 Sept 2023
Original language	Portuguese
Awarding Institution	Universidade Católica Portuguesa
Supervisor	Ana Filipa Teixeira da Silva (Supervisor)