Presentation of a clinical trials manual intended for patients and their families
The Clinical Trial - A Manual for Patients and their Families was promoted on Wednesday, 16 December 2009, in the Great Hall of the Andrija Štampar Institute of Public Health. The manual was prepared at the initiative of the publisher of the Coalition of Healthcare Sector Associations (KUZ) by Professor Dinko Vitezić, PhD, MD, president of the Central Ethics Committee.
The publication of the manual was supported by the Ministry of Health and Social Welfare, the Agency for Medicinal Products and Medical Devices and the Croatian Association of Research-based Pharmaceutical Companies.
The manual was presented by:
- Ms Mensura Dražić, PhD, BSC (Chem), president of the Coalition of Healthcare Sector Associations
- Professor Dinko Vitezić, PhD, MD, president of the Central Ethics Committee
- Ms Romana Katalinić, MD, Ministry of Health and Social Welfare
- Ms Adrijana Ilić Martinac, MSc (Pharm), head of the Director General's Office and the spokesperson for the Agency for Medicinal Products and Medical Devices
- Mr. Sani Pogorilić, MSc(Pharm), director of the Croatian Association of Research-based Pharmaceutical Companies
The Coalition of Healthcare Sector Associations (KUZ) decided to publish, with experts' asssistance, this informative manual intended for the broadest public, because it has been observed that citizens' insufficient knowledge about the issue of clinial trials leads to lack of trust in the process itself.
Implementation of clinical trials is regulated by a series of laws and regulations, as well as by ethical standards, and this manual is an opportunity to inform patients in greater detail of such regulations, methods of conducting clinical trials and their role in development of medicinal products, in a concise yet sufficiently informative way.
In the words of the manual's author, Professor Dinko Vitezić: "The primary object of the booklet is to assist in the gaining of basic knowledge about this important field, and to inspire interest in clinical trials".
Questions answered by the manual:
- What is a clinical trial and why is it necessary?
- Who can participate in the clinical research as a subject?
- What is an informed consent and why is it important for each and every subject?
- What are the risks of participation in a clinical trial?
- Who approves clinicial trials?
- What rights trial subjects have and how are they protected?
- What needs to be considered before taking part in clinical trials?
Electronic version of the manual is provided on the website of the Agency, under the Publications and reports section.