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This concise book is addressed to researchers, clinical investigators, as well as practicing physicians and surgeons who are interested in the fields of clinical research and trials. It covers some important topics related to clinical trials including an introduction to clinical trials, some aspects concerning clinical trials in pediatric age group, and the unique aspects of the design of clinical trials on stem cell therapy.
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This book Clinical Trials in Vulnerable Populations has 12 chapters divided into 4 sections: Minority Patients, Women, Medically Compromised Patients and Clinical Trials. Contributing authors came from several countries, from Serbia to Turkey. The book was edited by Professor Milica Prostran MD, Ph.D., specialist in Clinical Pharmacology. The potential reader is shown a modern approach to clinical trials in vulnerable populations, from different points of view. The chapters deal at length and clarity with their topics. Finally, I believe, that this book I edited and reviewed with dedication will capture the attention of many readers, from medical students to practicing doctors and pharmacists. All of whom must consider this very important field of medicine: clinical trials in vulnerable patients.
Clinical trials. --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Clinical medicine --- Human experimentation in medicine --- Research --- Medicine --- Public Health --- Health Care --- Health Sciences
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Human medicine --- Clinical medicine --- Medicine, Experimental --- Human experimentation in medicine --- Médecine clinique --- Médecine expérimentale --- Expérimentation humaine en médecine --- Biomedical Research --- Periodicals --- Périodiques --- Biomedical Research. --- Clinical Medicine. --- Human experimentation in medicine. --- Medicine, Experimental. --- Translational Medicine. --- Experimental medicine --- Experimentation on humans, Medical --- Medical experimentation on humans --- Medicine, Clinical --- Experimental Medicine --- Investigational Medicine --- Investigative Medicine --- Research, Biomedical --- Research, Medical --- Medical Research --- Medicine, Investigational --- Medicine, Investigative --- human experimentation --- translational medicine --- Medicine --- Medical ethics --- Clinical trials --- Animals, Laboratory --- Research
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I. Historiek bij de wet van 7 mei 2004 inzake experimenten op de menselijke persoon - II. Schema van de wet - III. Artikelsgewijze bespreking
gezondheidsrecht --- Tort and negligence --- medische ethiek --- medische experimenten --- Medical law --- Belgium --- Ethique médicale --- Législation --- Medische ethiek --- Wetgeving --- Human experimentation in medicine--Law and legislation--Belgium. --- Medical ethics--Belgium. --- 674 Gezondheidsrecht --- 061 Ethische problemen --- 614.1 --- ethiek (gez) --- experimenten --- wetgeving (gez) --- 601.7 --- patiëntenrecht --- patiëntveiligheid (veiligheid patiënt) --- 611.08 --- Medische experimenten : wetgeving --- België --- Medische experimenten --- Recht en ethiek --- Recht --- Wet van 7 mei 2004 inzake experimenten op de menselijke persoon --- experiment, experimenteel onderzoek (mensen) --- 13.12 --- (zie ook: beveiliging) --- Loi du 7 mai 2004 relative aux expérimentations sur la personne humaine --- expérimentation sur la personne humaine (chez l'humain) --- Wettelijke en contractuele aansprakelijkheid ; Geneesheren ; Veeartsen ; Apothekers ; Tandartsen ; Paramedici --- Human experimentation in medicine --- Law and legislation --- Provincie West-Vlaanderen --- Medical ethics--Belgium --- Professional ethics. Deontology --- Law --- recht --- bio-ethiek --- Human experimentation in medicine - Law and legislation - Belgium --- DROIT DE LA SANTE --- Bioéthique --- EXPERIMENTATIONS MEDICALES --- Essais cliniques --- Recherches biomédicales --- médicaments expérimentaux --- BELGIQUE
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Translational Medical Research. --- Clinical medicine --- Medicine, Experimental --- Human experimentation in medicine --- Research --- Medicine, Clinical --- Knowledge Translation --- Translational Medical Science --- Translational Medicine --- Translational Research, Medical --- Translational Research --- Knowledge Translations --- Medical Research, Translational --- Medical Science, Translational --- Medical Sciences, Translational --- Medical Translational Research --- Medicine, Translational --- Research, Medical Translational --- Research, Translational --- Research, Translational Medical --- Science, Translational Medical --- Sciences, Translational Medical --- Translation, Knowledge --- Translational Medical Sciences --- Translational Researchs --- Translations, Knowledge --- Experimentation on humans, Medical --- Medical experimentation on humans --- Human experimentation in medicine. --- Medicine, Experimental. --- Experimental medicine --- Research. --- Medicine --- National Center for Advancing Translational Sciences (U.S.) --- Medical ethics --- Clinical trials --- clinical science --- translational science --- health --- medicine --- Human medicine --- Translational Research, Biomedical.
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Cardiology --- Clinical trials --- Cardiovascular Diseases --- Cardiologie --- Etudes cliniques --- Periodicals --- therapy --- Periodicals. --- physiopathology --- Périodiques --- Cardiology. --- Clinical trials. --- therapy. --- physiopathology. --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Clinical medicine --- Human experimentation in medicine --- Heart --- Internal medicine --- Research --- Diseases
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Clinical trials --- Clinical Trials as Topic. --- Clinical trials. --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Clinical Trial as Topic --- design --- conduct --- analysis --- regulation and ethics --- transparency of medical research --- scientific validity --- Clinical medicine --- Human experimentation in medicine --- Clinical Protocols --- Drug Evaluation --- Drugs, Investigational --- Clinical Trials Data Monitoring Committees --- Therapies, Investigational --- Research
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The clinical trial on medicinal products stands in the area of conflict between important scientific progress in favour of future patients on the one hand and the necessary protection of human subjects on the other hand. This conflict grows more acute when vulnerable persons – like pregnant women – are included in medical research. Whereas there are specific regulations for minors or incapacitated persons in the German Medicinal Products Act, legal regulations for the inclusion of pregnant women are missing. Based on this uncertain legal situation solutions are developed, which will show a way out of the dilemma. Insofar as the applicable law does not provide a handle for this problem, a need for reform is shown.
Clinical trials. --- Obstetrical pharmacology. --- Drugs --- Law and legislation --- Obstetrics --- Pharmacology --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Clinical medicine --- Human experimentation in medicine --- Research --- pregnancy --- clinical trials --- pharmaceuticals --- Arzneimittel --- Fötus --- Grundgesetz für die Bundesrepublik Deutschland --- Klinische Studie --- Nasciturus (Deutschland) --- Schwangerschaft
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Deel I: Geoorloofdheid experimentele handelingen - Deel II: Civielrechtelijke aansprakelijkheid
Medical law --- Tort and negligence --- Deontologie --- Déontologie --- Ethique médicale --- Medische ethiek --- Human experimentation in medicine --- Law and legislation --- -001.891 --- 174.2 --- 351.84*7 --- biomedisch, medisch-wetenschappelijk onderzoek --- experiment, experimenteel onderzoek (mensen) --- aansprakelijkheid (schadevergoeding, burgerlijke aansprakelijkheid, beroepsaansprakelijkheid) --- rechtsvergelijking --- rechtsbescherming --- België --- 13.01.B --- Experimentation on humans, Medical --- Medical experimentation on humans --- Medical ethics --- Medicine --- Medicine, Experimental --- Clinical trials --- recherche biomédicale --- expérimentation sur la personne humaine (chez l'humain) --- responsabilité (indemnisation, responsabilité civile, responsabilité professionnelle) --- droit comparé --- protection juridique --- Belgique --- Wettelijke en contractuele aansprakelijkheid ; Algemeen ; België --- Research --- 001.891 --- België --- responsabilité (indemnisation, responsabilité civile, responsabilité professionnelle) --- recherche biomédicale --- expérimentation sur la personne humaine (chez l'humain) --- droit comparé --- Wettelijke en contractuele aansprakelijkheid ; Algemeen ; België --- E-books --- Human experimentation in medicine - Law and legislation - Belgium --- DROIT MEDICAL --- EXPERIMENTATION MEDICALE --- BIOETHIQUE
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Biomedical Research. --- Clinical Medicine. --- Medicine, Experimental --- Human experimentation in medicine --- Médecine expérimentale --- Expérimentation humaine en médecine --- Periodicals. --- Périodiques --- Human experimentation in medicine. --- Medicine, Experimental. --- Medicine, Clinical --- Experimental Medicine --- Investigational Medicine --- Investigative Medicine --- Research, Biomedical --- Research, Medical --- Medical Research --- Medicine, Investigational --- Medicine, Investigative --- Experimental medicine --- Experimentation on humans, Medical --- Medical experimentation on humans --- translational medicine --- Animals, Laboratory --- Medicine --- Medical ethics --- Clinical trials --- Research --- Translational Medical Research. --- Knowledge Translation --- Translational Medical Science --- Translational Medicine --- Translational Research, Medical --- Translational Research --- Knowledge Translations --- Medical Research, Translational --- Medical Science, Translational --- Medical Sciences, Translational --- Medical Translational Research --- Medicine, Translational --- Research, Medical Translational --- Research, Translational --- Research, Translational Medical --- Science, Translational Medical --- Sciences, Translational Medical --- Translation, Knowledge --- Translational Medical Sciences --- Translational Researchs --- Translations, Knowledge --- National Center for Advancing Translational Sciences (U.S.) --- Translational Research, Biomedical --- Human medicine --- Translational Research, Biomedical.
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