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Patients'Recruitment Issues in Clinical Trials
Hrubá, Dagmar ; Doskočil, Ondřej (advisor) ; Štegmannová, Ingrid (referee)
This thesis examines patient recruitment in clinical trials. It is a current and pressing issue, which is not sufficiently embedded in the thinking of doctors and patients, their patterns of communication, and more broadly in the traditional doctor-patient relationship, which continues to be burdened by post-socialist paternalism. The formal framework and ethics have been developed relatively recently, and their application causes confusion to all participants regarding how to proceed in specific situations. In addition, the choice of topic, and especially the form of dealing with the topic, was motivated by the relative lack of academic resources and publications in the field. The theoretical section of the thesis defines clinical research and its phases, and introduces basic terminology and documents closely linked to clinical research. In addition, it focuses on research ethics, thoroughly examining the issue of informed consent - a fundamental document necessary for recruiting a patient in a clinical trial. Finally, one chapter of the thesis focuses on the issue of medical literacy, the level of which is integral to the participants' understanding of the importance of clinical research, and directly affects participants' decision-making. The empirical section is divided into two parts. The...
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Legal Aspects of Clinical Drug Research
Kulan, Kryštof ; Šustek, Petr (advisor) ; Salač, Josef (referee)
Legal Aspects of Clinical Drug Research Abstract The aim of this work is the evaluation of the current situation in the clinical study of medication, description of the rights and the protection of the subject of evaluation in the research and solution of selected questions, which may be confusing or at least unclear for the average person. Furthermore, this thesis discusses the exercise of the rights of the subject of the research with focus on damages incurred by the subject of evaluation and to his close persons. The last question is payment for participation in clinical research and other benefits that the subject of the evaluation gains for the participation. Through this methodology, this work has resulted in a detailed analysis of the rights of the subject, especially in relation to his / hers personal rights, their protection and performance. Through the method described above, it brings a new perspective on the relationship of liability for the damage caused to the subject of the clinical research. It also presents arguments pointing to the necessity to change the actual but legally unsatisfactory status of the reimbursements provided for participation in the clinical research. The main findings of this work are the clarification of the liability in relationships that arise in clinical research....
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Patients'Recruitment Issues in Clinical Trials
Hrubá, Dagmar ; Doskočil, Ondřej (advisor) ; Štegmannová, Ingrid (referee)
This thesis examines patient recruitment in clinical trials. It is a current and pressing issue, which is not sufficiently embedded in the thinking of doctors and patients, their patterns of communication, and more broadly in the traditional doctor-patient relationship, which continues to be burdened by post-socialist paternalism. The formal framework and ethics have been developed relatively recently, and their application causes confusion to all participants regarding how to proceed in specific situations. In addition, the choice of topic, and especially the form of dealing with the topic, was motivated by the relative lack of academic resources and publications in the field. The theoretical section of the thesis defines clinical research and its phases, and introduces basic terminology and documents closely linked to clinical research. In addition, it focuses on research ethics, thoroughly examining the issue of informed consent - a fundamental document necessary for recruiting a patient in a clinical trial. Finally, one chapter of the thesis focuses on the issue of medical literacy, the level of which is integral to the participants' understanding of the importance of clinical research, and directly affects participants' decision-making. The empirical section is divided into two parts. The...
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