Κλινικές μελέτες: νομικό πλαίσιο - οικονομικές διαστάσεις της ερευνητικής δραστηριότητας στην Ελλάδα

Κοσμίδη, Σοφία

Clinical trials: legal framework - economic dimensions of research activity in Greece

Master Thesis

Author

Κοσμίδη, Σοφία

Date

2017

Abstract

Research is any systematic and creative work that is undertaken in order to increase the knowledge pool, including knowledge about humanity, culture and society." Medical research focuses on increasing the knowledge pool about human beings. Its origins are found in the distant past, it concerns a wide range of fields with scope the promotion, preservation, protection and restoration of human health through the early diagnosis and treatment of diseases. Clinical trial as a concept consists of carefully designed research studies carried out with volunteers help. Tests purpose is to answer specific questions concerning the effectiveness of interventions and diagnostic methods. They are realized to adopt a new medical treatment, documenting the safety maintenance and efficacy of new drugs. This study attempts to present the concept of clinical trial and the contribution to the use of trial findings in clinical practice. In this aspect, it describes the global current legislative framework, but also is focused particularly in Greece. Reference is made to recent changes that have been adopted and will soon come into force. Concluding, a relationship is “rising” between the clinical trial activity and the economic dimensions, which are shaped in Greece nowadays. For this purpose, the thesis is structured in six chapters: In the first chapter, the definition of the clinical trial is firstly clarified. Then, the different kinds and the stages of its development are mentioned and identified. xiv Volunteer patient’ s involvement during the development of the process is marked, which is an expression of autonomy, right and at the same time responsibility, and it is sealed with the completion of the necessary informed consent process. In the second chapter, through a brief historical review of the main ethical codes, the relationship between ethics and clinical trials is identified. Points of reflections are developed and an overview of the current global and our country’s legislation is realised. The third chapter analyzes the basic principles of bioethics that define the requirements for conducting ethically wised clinical trials.The content of the fourth chapter is linked to the new Regulation 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials for human beings as the most updated legislative proposal. It outlines its connection with the previous regulatory framework and clarifies the institutional innovations it introduces. In the fifth chapter, highlights is noticed the contribution of clinical trials to the economy and the scope for growth that is available for the industry. The sixth and final chapter is dedicated to suggestions and final conclusions

Postgraduate Studies Programme

Οικονομικά και Διοίκηση της Υγείας

Department

Σχολή Οικονομικών, Επιχειρηματικών και Διεθνών Σπουδών. Τμήμα Οικονομικής Επιστήμης

Number of pages

127

Language

Greek

URI

https://dione.lib.unipi.gr/xmlui/handle/unipi/10495

Collections

Τμήμα Οικονομικής Επιστήμης

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