During the 5 years of University, I have wondered many times what profession I could undertake after my dissertation and all the possible options that come with it. I have a great belief that the investigation on medicines which includes clinical studies, in order to place this on the market is particularly stimulating and congenial to my skills. Therefore, in my thesis workshop I wanted to show in depth the activities that pharmaceutical companies must carry out; being able to demonstrate the effectiveness and safety that the drugs need to prove in order to obtain an authorized place on the market. For this workshop, I took in consideration different clinical studies such as the steps that must be taken in order to convey the whole procedure, the Clinical Trial Information System (CTIS), as part of the Good Clinical Practice (GCP). Clinical trials can be carried out within the company or by external organizations (CROs), which can be partially or in full responsible for the trial. In the thesis I have illustrated how the CROs job is organized and the function of the Clinical Research Associate (CRA); a figure with many skills, responsibilities, that acts as an intermediary, on behalf of the Contract Research Organization (CRO), with the sponsor (pharmaceutical company), experimenters and ethics committees. The CRA has the responsibility to coordinate, monitor and report the results of the clinical, toxicological and pharmacovigilance trials. As part of the procedure,the sponsor will provide the Associate with an Investigators' Brochure (IB). This contains all the information related to the active ingredient or the investigational drug. In my research, due to the outcome of the results, I have examined some cases of clinical studies that led to the suspension of the trials and in the worst case scenario at the revocation of the marketing authorization. As an example of a clinical evaluation, I have described the study protocol of an active drug in breast cancer, the analysis’s target, the criteria for the subjects to be more or less recruited for the research, the therapy, the duration and the outcome of the investigation itself.
Durante i 5 anni di studi universitari mi sono chiesta molte volte quale sarebbe stata la professione che avrei potuto intraprendere dopo la laurea e, di tutte le possibili opzioni, mi sono convinta che il settore che riguarda gli studi clinici per l’immissione in commercio dei medicinali è particolarmente stimolante e congeniale alle mie attitudini. Per questo, nel mio lavoro di tesi, ho voluto approfondire l’attività che le aziende farmaceutiche devono svolgere per dimostrare l’efficacia e la sicurezza dei medicinali, in modo di ottenere l’autorizzazione all’immissione in commercio. Ho preso in esame i differenti studi clinici, le fasi in cui procedono, il Clinical Trial Information System (CTIS) e le Good Clinical Practice (GCP). Gli studi clinici possono essere svolti all’interno dell’azienda o da organizzazioni esterne (CRO), che si possono fare carico di parte o di tutta la sperimentazione. Nella tesi ho illustrato come è organizzato il lavoro dei CRO e la funzione del Clinical Research Associate (CRA), una figura con molte competenze e responsabilità, che si interfaccia, per conto della Contract Research Organization (CRO), con lo sponsor (azienda farmaceutica), gli sperimentatori, i comitati etici. Il CRA quindi coordina, controlla e riferisce i risultati della sperimentazione clinica, tossicologica e della farmacovigilanza. Inoltre, riceve dallo sponsor l’Investigators’s Brochure (IB) che contiene tutte le informazioni relative al principio attivo o al farmaco sperimentale. Nella mia ricerca ho preso in esame casi di studi clinici che hanno portato, per i risultati ottenuti, alla sospensione delle sperimentazioni o addirittura alla revoca dell’AIC. Come esempio di studio clinico ho descritto il protocollo di studio di un farmaco attivo nella neoplasia della mammella, gli obiettivi dello studio, i criteri di inclusione ed esclusione per il reclutamento dei soggetti, la terapia, la durata e le prospettive dello studio stesso.
Studi clinici attraverso CRO e CRA
ZAHARIA, REBECA ALEXANDRA
2020/2021
Abstract
During the 5 years of University, I have wondered many times what profession I could undertake after my dissertation and all the possible options that come with it. I have a great belief that the investigation on medicines which includes clinical studies, in order to place this on the market is particularly stimulating and congenial to my skills. Therefore, in my thesis workshop I wanted to show in depth the activities that pharmaceutical companies must carry out; being able to demonstrate the effectiveness and safety that the drugs need to prove in order to obtain an authorized place on the market. For this workshop, I took in consideration different clinical studies such as the steps that must be taken in order to convey the whole procedure, the Clinical Trial Information System (CTIS), as part of the Good Clinical Practice (GCP). Clinical trials can be carried out within the company or by external organizations (CROs), which can be partially or in full responsible for the trial. In the thesis I have illustrated how the CROs job is organized and the function of the Clinical Research Associate (CRA); a figure with many skills, responsibilities, that acts as an intermediary, on behalf of the Contract Research Organization (CRO), with the sponsor (pharmaceutical company), experimenters and ethics committees. The CRA has the responsibility to coordinate, monitor and report the results of the clinical, toxicological and pharmacovigilance trials. As part of the procedure,the sponsor will provide the Associate with an Investigators' Brochure (IB). This contains all the information related to the active ingredient or the investigational drug. In my research, due to the outcome of the results, I have examined some cases of clinical studies that led to the suspension of the trials and in the worst case scenario at the revocation of the marketing authorization. As an example of a clinical evaluation, I have described the study protocol of an active drug in breast cancer, the analysis’s target, the criteria for the subjects to be more or less recruited for the research, the therapy, the duration and the outcome of the investigation itself.È consentito all'utente scaricare e condividere i documenti disponibili a testo pieno in UNITESI UNIPV nel rispetto della licenza Creative Commons del tipo CC BY NC ND.
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https://hdl.handle.net/20.500.14239/14339