This master thesis is a description of the clinical trial, which is part of medical law un- der the law aspects. This thesis is split to topic, whose a brief outline is in the introduction. Process of the clinical trial and their institutions are discussed under the law and medical aspects. Resources of this thesis are a professional literature, knowledge of experts from pharmaceutical company and my own experience from part-time job in this type of com- panies. Aim of the thesis is to bring more resources and information about that topic to experts and other people who are interested in. This thesis is devided into five chapters. First chapter is speaking about a general insti- tute in the clinical trial. There are listed sources of the law. In the next chapter I deal with the process of the clinical trial from the begining i.e. from the development of a new sub- stance through the clinical trial to the final registration. The chapter about the european law regulation is following. In the fourth chapter I deal with the ethical aspects, which are conected with clinical trial. In that part I emphasised the influence of the international ethical documents. The last chapter is conclusion, where I describe the goal of this master thesis and also I am linking to the opinions of authorities regarding the...

1 Abstract Charles University, Faculty of Pharmacy in Hradec Králové Department of Pharmacognosy Student: Olga Krupová Supervisor: PharmDr. Tomáš Siatka, CSc. Title of diploma thesis: Modern phytotherapy - revision of usage of medicinal plants according to clinical trials Key words: phytotherapy, medicinal plants, liver diseases, painful joints, nervousness and insomnia, clinical trials The aim of diploma thesis was to review the said effects of the herbs, to make a list of herbs used in popular traditional medicine of selected diseases and to verify their use by giving documented evidence. This thesis addresses in detail three ranges of problems in which the use of herbal therapy could be considered. Following three ranges of problems were selected: liver diseases, painful joints, nervousness and insomnia. Clinical studies were explored to substantiate the effects of individual herbs or their substances. Preclinical studies were used in case of deficiency in clinical studies. The outcome of this thesis was to approve or - on the contrary - to disapprove the effects quoted by the use of folk medicine herbs. From the result of this thesis it emerges, that not all popular quoted herbal indications are verified by sufficient evidence. However, for a considerable part of the quoted herbs their effects were...

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The subject of my dissertation is fraud in clinical trials in terms of ethics and law. The aim of my research was to analyze the frequency of fraud in clinical trials of a given sample of data collected, identify the main fraudsters and to analyze the causes that led participants in clinical trials to commit fraud. In the theoretical part of my dissertation I defined the concepts of clinical trials, deception, ethical issues and the relevant legal framework. The practical part contains the results of the data analysis of the incidence and causes of fraud, the main actors of fraud and conception of recommendations, which appears to be essential for the prevention of fraud in clinical trials. The data analysis and participant observation show that during 107 GCP (Good Glinical Practice) audits conducted during the period of 2008-2013 in 22 countries, 14 revelations of fraud in clinical trials were identified, which represents 13.1 %. Most often fraud was committed by investigators, a total of 47.6 % of all observed groups of cheating clinical trial participants. The main causes that led investigators to commit fraud represent a lack of eligible patients, financial gain and personality traits. Based on the results obtained during my research I highlighted in the practical part of my dissertation the ethical...

The subject of my dissertation is fraud in clinical trials in terms of ethics and law. The aim of my research was to analyze the frequency of fraud in clinical trials of a given sample of data collected, identify the main fraudsters and to analyze the causes that led participants in clinical trials to commit fraud. In the theoretical part of my dissertation I defined the concepts of clinical trials, deception, ethical issues and the relevant legal framework. The practical part contains the results of the data analysis of the incidence and causes of fraud, the main actors of fraud and conception of recommendations, which appears to be essential for the prevention of fraud in clinical trials. The data analysis and participant observation show that during 107 GCP (Good Glinical Practice) audits conducted during the period of 2008-2013 in 22 countries, 14 revelations of fraud in clinical trials were identified, which represents 13.1 %. Most often fraud was committed by investigators, a total of 47.6 % of all observed groups of cheating clinical trial participants. The main causes that led investigators to commit fraud represent a lack of eligible patients, financial gain and personality traits. Based on the results obtained during my research I highlighted in the practical part of my dissertation the ethical...

Mass spectrometry (MS) is a rapid, specific and very sensitive analytical method with a broad spectrum of proteomic applications such as protein identification and sequencing, 3D protein structure characterization or study of protein-protein interaction. The introduction of two ionization techniques in late 1980's that are able to ionize the large biomolecules such as proteins, oligosaccharides or nucleic acids with no or low fragmentation has started the rapidly expanding field of MS-based proteomics. The presented thesis was aimed at the application of mass spectrometric approaches to answer several proteomic questions. Firstly we have employed the chemical cross-linking in combination with MS analysis to solve the 3D structure and protein-protein interactions of three model systems: (1) homodimeric human regulatory protein 14-3-3, (2) model of 14-3-3 and regulatory domain of tyrosine hydroxylase, and (3) system of two membrane proteins, cytochrome P450 2B4 and cytochrome b5, involved in xenobiotics biotransformation. This approach works in aqueous solutions under physiological conditions and thus preserves native structure of the investigated proteins. The second part of the thesis was focused on MS identification of proteins/peptides in fungal spores of Aspergillus and Pseudallescheria...

Title: Interrater reliability of assessment set of clinical features of patients with multiple sclerosis Objectives: The aim of this thesis is to verify interrater reliability of the assessment set of clinical features of patients with multiple sclerosis which purpose is to evaluate sensitivly and comprehensivly the stage of the patients' clinical condition. Methods: According to the inclusion criteria, the patients with MS were selected by an independent neurologist who determined the EDSS score and duration of the disease. After, patients were evaluated by the assessment set by two independent physiotherapists. The assessment set of clinical features incluedes Low-Contrast Letter Acuity Test which tests contrast vision, Nine Hole Peg Test investiges fine motor skills, Timed 25 - Foot Walk evaluates walking speed over a distance of 7,5 m, Paced Auditory Serial Addition assesses cognitive function, Motricity Index tests muscle strength, Modified Ashworth Scale spasticity, Berg balance Scale equilibrium. Furthemore, the tests for evaluation of righting, equilibrium and protective reactions, the test evaluating knee hyperextension, the examination of dysdiadochokinesia and ataxia. Results: High interrater reliability was confirmed in all tests in the examinig set (ICC: 0,80 - 1), except for MAS...

This diploma thesis, "Alzheimer's disabilities ", deals with questions around people with Alzheimer's disabilities, which is the most common type of dementia. Alzheimer's disabilities is also very widespread in the population; and it is the 4th or 5th most common cause of death. The thesis is divided into two parts, the first part is theoretical and the second is empirical. In the theoretical part the thesis deals with the general characteristics of this disorder such as: causes, prevention, clinical manifestations, consequences, diagnostics and pharmacological approaches. The main focus of the theoretical part is in the second chapter, which deals with non-pharmacological approaches to people with Alzheimer's disabilities. In the empirical part, case studies on sufferers of Alzheimer's disabilities will be included. The empirical part focuses on substantive changes which occur in the lives of people with Alzheimer's disabilities, and whether these changes can be confirmed as being consequential of the affliction. Key words Dementia, Alzheimer's disabilities, clinical manifestation, non-pharmacological approaches.

Clinical trials of medicinal products is increasingly important area of pharmaceutical law. Number of clinical trials and amount of financial resources is constantly rising and therefore the rules and principles of the clinical trials itself are being clarified overtime. This diploma thesis aims to provide an overview of the basic aspects of clinical trials of medicinal products for human use from a legal point of view. The author focuses in particular on the national legislation of clinical trials, which is complemented by the legislation of the European Union and important sources of the international law. Author is more closely analysing the particular procedures performed within the clinical trials, especially from the point of view of the administrative law. Particular attention is paid to the ethical review of the clinical trials, their particular aspects and the overall concept. The thesis is divided into twelve chapters. In the introduction, the author focuses on the development of the clinical trials and mentions the crucial moments that contributed to the formulation of the basic rules of the clinical trials. The following chapter focuses on the sources of law. Firstly, sources of international law are described, where more general sources and specific sources of law of medicinal products...

The immunotherapeutic drug DCVAC/OvCa is being tested in the treatment of ovarian cancer patients within the SOV02 clinical trial (Eudra CT number: 2013-001323-38). Ovarian cancer belongs to gynaecological malignancies with the highest mortality rate. Around 60% of patients are diagnosed at advanced stages. Despite the initial successful treatment, relapses occur in most cases, and the disease often becomes resistant to chemotherapy. Effective therapy for relapsed or metastatic patients is still missing. The solution could be immunotherapeutic treatment. DCVAC is an active cellular immunotherapy based on autologous dendritic cells. The aim of this diploma thesis was monitoring of immune parameters in samples from clinical trial SOV02 patients during the time period defined in the study protocol. We have monitored the presence of antigen specific T lymphocytes, tumor specific antibodies, immunosuppressive populations of regulatory T cells and MDSC cells, and also the expression of inhibitory molecules on the surface of T lymphocytes. We observed higher levels of Her-2, Muc-1 and MAGE-A1 antibodies in the DCVAC/OvCa treated group of patients versus the control group. Significant differences in the other monitored parameters were not observed. However, a large amount of data have been obtained that...