My MSc thesis is focused on parametric designs of Phase I clinical trials, using the continual reassessment method. A parametric model with unknown parameters is assumed. The observations are either toxic or nontoxic. Observations of toxicities are used to update the posterior distribution. Dose selection for the next patient is based on the estimated toxicity probability. The objective is to identify the maximum tolerated dose to be used in Phase II clinical trials. We introduce a new class of parametric functions for the continual reassessment method. This class is formed with the cumulative distribution function of the normal distribution. The major advantage is that we can choose different normal distributions to model different toxicity probability functions. We conduct simulation studies and compare our new design with the existing parametric designs, and have found that our design performs better by choosing the appropriate values of the mean and variance. / October 2016

(in English): The subject of my dissertation is the decision of the subjects to participate in the early phase of clinical trial. The aim of this disseration is to detect and understand the ethical aspects of decision making of subjects with oncological diseases to participate in the early phase of clinical trial. In the theoretical part of my dissertation, I define the field of clinical research, describe the phases of clinical research and ethical codes important for clinical research. The current ethical dilemmas related to the participation of subjects in the early phase of clinical trial, which are being discussed by the professional public, are presented. The research part contains the results of interviews with seventeen respondents whose content correlates with the aim of the research part and it is to understand the decision- making of subjects to participate in the early phase of clinical trial in terms of subjectively constructed realities, which are different for individual respondents. The results of the research show that fourteen respondents identified one of the most important aspects of the decision-making to participate in the early phase of clinical trial of the recommendation of principal investigator and trust in a physician. Twelve respondents stated the most frequent reason...

(in English): The subject of my dissertation is the decision of the subjects to participate in the early phase of clinical trial. The aim of this disseration is to detect and understand the ethical aspects of decision making of subjects with oncological diseases to participate in the early phase of clinical trial. In the theoretical part of my dissertation, I define the field of clinical research, describe the phases of clinical research and ethical codes important for clinical research. The current ethical dilemmas related to the participation of subjects in the early phase of clinical trial, which are being discussed by the professional public, are presented. The research part contains the results of interviews with seventeen respondents whose content correlates with the aim of the research part and it is to understand the decision- making of subjects to participate in the early phase of clinical trial in terms of subjectively constructed realities, which are different for individual respondents. The results of the research show that fourteen respondents identified one of the most important aspects of the decision-making to participate in the early phase of clinical trial of the recommendation of principal investigator and trust in a physician. Twelve respondents stated the most frequent reason...