Οργάνωση κλινικής μελέτης & συμβολή των κλινικών μελετών στην οικονομία
Organization of a clinical study & contribution of clinical studies on the economy
SubjectΚλινικές μελέτες ; Φαρμακευτική βιομηχανία και εμπόριο ; Clinical trials -- Economic aspects ; Pharmaceutical industry ; Drugs -- Testing
This study could be considered as being divided into two parts. The first part is a detailed description of the organization of a credible and scientifically valuable clinical trial. The concept and the procedure of the study protocol's creation is described thoroughly, as well as the proper and effective structure of the study protocol, the Case Report Forms (CRF) and the regulations regarding the conduct of clinical studies, according to the ICH - GCP guidelines. Subsequently, the preparation of study materials and study drug (Investigational Medicinal Product-IMP), as well as the procedures needed to be followed in order to ensure the required approvals from the relevant committees are described in detail. An eXtensive description of how surveillance of the study is conducted (monitoring), the patient's recruitment procedure, the completion of the CRFs, the management of the data and the statistical analysis procedure follows. Also, the roles of the monitors, auditors and the research team, as well as the procedure of the data reported in statistical analysis and publication of results are presented in detail. Also, this study refers to the responsibility of the sponsor (pharmaceutical company) and its staff to deal with the feasibility process, the first contact with the most suitable, equipped and well trained sites( clinics - hospitals - Principal Investigators and collaborators). The second part refers to the contribution of clinical studies in the economy - not only in the terms of each country, but also globally. A thorough description of clinical trials conducted in the United States of America, in Europe, in Japan and Greece is reported. More specifically, reference is made to the number, the cost and the impact in the national and global economy of the studies conducted to each of these countries. Conclusion and proposals follows and finally the bibliographic references.