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Background: Phase I clinical trials (PICT) are the first stage a new drug is tested in humans. The effects of investigational medicinal products (IMP) in humans are therefore unknown. Hospital pharmacists have been involved in clinical trials for many years. The management of PICT by hospital pharmacists has not been described yet. Objective: The aim of the study was to analyze the management of PICT in a hospital pharmacy and to compare practices between 4 hospitals and 2 clinical research units (CRU) in France and Belgium in order to identify potential difficulties related to the management of PICT by pharmacists and to elaborate some recommendations. Methods: It was a descriptive observational study. First in a Belgian teaching hospital, we identified and characterized the management of PICT at the pharmacy. Data on PICT prescriptions with preparation were collected. Secondly, in 3 other hospital pharmacies and in 2 pharmacy services CRU we analyzed the management of PICT. A pharmacist of each pharmacy was interviewed. Results: In hospitals the majority of PICT is commercial studies conducted in oncology. At the first hospital we received 84 prescriptions for PICT with a preparation during the collect from 11 protocols. In the 2 clinical research units PICT involve healthy volunteers. In hospital pharmacies no major differences between the management of PICT and phases II and III clinical trials was observed except for the transport from pharmacy to patient. Some difficulties related to commercial bags were explained by interviewed pharmacists. Conclusions: This study highlights for the first time the management of PICT in hospital pharmacies. This is comparable to the management of phase II and III trials. Some difficulties were highlighted regarding preparations of PICT IMP: complexity, timing and non-exact volume with commercial bags. A planning with patients in PICT could be organized for pharmacies. The study could be repeated in other hospitals to confirm these results.

Clinical Trials, Phase I as Topic --- Pharmacy Service, Hospital --- Hospitals, University

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Drugs --- Clinical trials --- Clinical Trials, Phase I as Topic --- Clinical Trials, Phase II as Topic --- Models, Statistical --- Statistics as Topic --- Biometry

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A legal and moral analysis of medical decision making on behalf of those with such severe cognitive impairments that they cannot exercise self-determination.In this book, Norman Cantor analyzes the legal and moral status of people with profound mental disabilities--those with extreme cognitive impairments that prevent their exercise of medical self-determination. He proposes a legal and moral framework for surrogate medical decision making on their behalf. The issues Cantor explores will be of interest to professionals in law, medicine, psychology, philosophy, and ethics, as well as to parents, guardians, and health care providers who face perplexing issues in the context of surrogate medical decision making.The profoundly mentally disabled are thought by some moral philosophers to lack the minimum cognitive ability for personhood. Countering this position, Cantor advances both theoretical and practical arguments for according them full legal and moral status. He also argues that the concept of intrinsic human dignity should have an integral role in shaping the bounds of surrogate decision making. Thus, he claims, while profoundly mentally disabled persons are not entitled to make their own medical decisions, respect for intrinsic human dignity dictates their right to have a conscientious surrogate make medical decisions on their behalf. Cantor discusses the criteria that bind such surrogates. He asserts, contrary to popular wisdom, that the best interests of the disabled person are not always the determinative standard: the interests of family or others can sometimes be considered. Surrogates may even, consistent with the intrinsic human dignity standard, sometimes authorize tissue donation or participation in nontherapeutic medical research by profoundly disabled persons. Intrinsic human dignity limits the occasions for such decisions and dictates close attention to the preferences and feelings of the profoundly disabled persons themselves. Cantor also analyzes the underlying philosophical rationale that makes these decision-making criteria consistent with law and morals.

Conservatorships --- Informed consent (Medical law) --- Insanity (Law) --- Medical ethics --- Mental health laws --- Consentement éclairé (Droit médical) --- Droit à la mort --- Santé mentale --- Tutelle et curatelle --- Éthique médicale --- Mental Competency --- Mentally Disabled Persons --- Decision Making --- Informed Consent --- Legal Guardians --- Right to Die --- Behavior and Behavior Mechanisms --- Human Rights --- Psychological Phenomena and Processes --- Human Experimentation --- Social Control, Formal --- Jurisprudence --- Principle-Based Ethics --- Sterilization, Reproductive --- Freedom --- Disabled Persons --- Ethics --- Thinking --- Social Control, Informal --- Persons --- Health Services --- Named Groups --- Sociology --- Philosophy --- Humanities --- Psychiatry and Psychology --- Health Care Facilities, Manpower, and Services --- Biomedical Research --- Investigative Techniques --- Mental Processes --- Research --- Urogenital Surgical Procedures --- Health Care --- Health Care Economics and Organizations --- Science --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Social Sciences --- Surgical Procedures, Operative --- Anthropology, Education, Sociology and Social Phenomena --- Natural Science Disciplines --- Disciplines and Occupations --- Ethical Analysis --- Personal Autonomy --- Nontherapeutic Human Experimentation --- Personhood --- Tissue and Organ Procurement --- Third-Party Consent --- Coercion --- Patient Rights --- Sterilization, Involuntary --- Law - U.S. --- Law, Politics & Government --- Disabled Legislation - U.S. --- Decision making. --- Droit --- Prise de décision. --- legislation & jurisprudence --- ethics --- Decision making --- United States --- Libertarianism --- Liberty --- Freedoms --- Female Sterilization --- Female Sterilization, Voluntary --- Male Sterilization --- Male Sterilization, Voluntary --- Reproductive Sterilization --- Voluntary Sterilization --- Female Sterilizations --- Female Sterilizations, Voluntary --- Male Sterilizations --- Male Sterilizations, Voluntary --- Reproductive Sterilizations --- Sterilization, Female --- Sterilization, Male --- Sterilization, Voluntary --- Sterilizations, Female --- Sterilizations, Male --- Sterilizations, Reproductive --- Sterilizations, Voluntary --- Voluntary Female Sterilization --- Voluntary Female Sterilizations --- Voluntary Male Sterilization --- Voluntary Male Sterilizations --- Voluntary Sterilizations --- Principlism --- Ethic, Principle-Based --- Ethics, Principle-Based --- Principle Based Ethics --- Principle-Based Ethic --- Constitutional Law --- Court Decision --- Law --- Legal Aspects --- Legal Obligations --- Legal Status --- State Interest --- Litigation --- Medical Jurisprudence --- Aspect, Legal --- Aspects, Legal --- Constitutional Laws --- Court Decisions --- Decision, Court --- Decisions, Court --- Interest, State --- Interests, State --- Jurisprudence, Medical --- Law, Constitutional --- Laws --- Laws, Constitutional --- Legal Aspect --- Legal Obligation --- Litigations --- Obligation, Legal --- Obligations, Legal --- State Interests --- Status, Legal --- Regulation --- Social Control --- Control, Social --- Controls, Social --- Formal Social Control --- Formal Social Controls --- Regulations --- Social Controls --- Human Research Subject Protection --- Experimentation, Human --- Psychologic Processes and Principles --- Equal Rights --- Equal Right --- Human Right --- Right, Equal --- Right, Human --- Rights, Equal --- Rights, Human --- Conservators --- Law and mental illness --- Mental disability law --- Mental health --- Mental illness --- Mental illness and law --- Mentally ill --- People with mental disabilities --- Decision Making, Shared --- Decision Makings, Shared --- Making, Shared Decision --- Makings, Shared Decision --- Shared Decision Making --- Shared Decision Makings --- Death with Dignity --- Dignity, Death with --- Guardian, Legal --- Guardians, Legal --- Legal Guardian --- Consent, Informed --- Competence --- Incompetence, Mental --- Mental Competence --- Competency, Mental --- Incompetency, Mental --- Competence, Mental --- Mental Incompetence --- Mental Incompetency --- Mentally Retarded --- Mentally Disabled --- Mentally Handicapped --- Disabled, Mentally --- Mentally Disabled Person --- Person, Mentally Disabled --- Persons, Mentally Disabled --- Biomedical ethics --- Clinical ethics --- Ethics, Medical --- Health care ethics --- Medical care --- Medicine --- Compulsory Sterilization --- Forced Sterilization --- Involuntary Sterilization --- Compulsory Sterilizations --- Forced Sterilizations --- Involuntary Sterilizations --- Sterilization, Compulsory --- Sterilization, Forced --- Sterilizations, Compulsory --- Sterilizations, Forced --- Sterilizations, Involuntary --- Patient's Rights --- Patients' Rights --- Right to Treatment --- Patient Right --- Patient's Right --- Patients Rights --- Patients' Right --- Right to Treatments --- Right, Patient --- Right, Patient's --- Right, Patients' --- Rights, Patient --- Rights, Patient's --- Rights, Patients' --- Treatment, Right to --- Treatments, Right to --- Involuntary Fertility Control --- Fertility Control, Involuntary --- Donor Cards --- Organ Donation --- Required Organ Donation Request --- Required Request --- Tissue Donation --- Organ Procurement --- Organ Procurement Systems --- Tissue Procurement --- Card, Donor --- Cards, Donor --- Donor Card --- Organ Donations --- Organ Procurement System --- Organ Procurements --- Required Requests --- Tissue Donations --- Tissue Procurements --- Human Dignity --- Dignity, Human --- Nontherapeutic Research --- Research, Nontherapeutic --- Human Experimentation, Nontherapeutic --- Experimentation, Nontherapeutic Human --- Free Will --- Self Determination --- Autonomy, Personal --- Analysis, Ethical --- Analyses, Ethical --- Ethical Analyses --- Natural Sciences --- Physical Sciences --- Discipline, Natural Science --- Disciplines, Natural Science --- Natural Science --- Natural Science Discipline --- Physical Science --- Science, Natural --- Science, Physical --- Sciences, Natural --- Sciences, Physical --- Ghost Surgery --- Operative Procedures --- Operative Surgical Procedure --- Operative Surgical Procedures --- Procedure, Operative Surgical --- Procedures, Operative Surgical --- Surgery, Ghost --- Surgical Procedure, Operative --- Operative Procedure --- Procedure, Operative --- Procedures, Operative --- Science, Social --- Sciences, Social --- Social Science --- Sciences --- Healthcare Economics and Organizations --- Healthcare Facilities, Manpower, and Services --- Community-Based Distribution --- Contraceptive Distribution --- Delivery of Healthcare --- Dental Care Delivery --- Distribution, Non-Clinical --- Distribution, Nonclinical --- Distributional Activities --- Healthcare --- Healthcare Delivery --- Healthcare Systems --- Non-Clinical Distribution --- Nonclinical Distribution --- Delivery of Dental Care --- Health Care Delivery --- Health Care Systems --- Activities, Distributional --- Activity, Distributional --- Care, Health --- Community Based Distribution --- Community-Based Distributions --- Contraceptive Distributions --- Deliveries, Healthcare --- Delivery, Dental Care --- Delivery, Health Care --- Delivery, Healthcare --- Distribution, Community-Based --- Distribution, Contraceptive --- Distribution, Non Clinical --- Distributional Activity --- Distributions, Community-Based --- Distributions, Contraceptive --- Distributions, Non-Clinical --- Distributions, Nonclinical --- Health Care System --- Healthcare Deliveries --- Healthcare System --- Non Clinical Distribution --- Non-Clinical Distributions --- Nonclinical Distributions --- System, Health Care --- System, Healthcare --- Systems, Health Care --- Systems, Healthcare --- Procedure, Urogenital Surgical --- Procedures, Urogenital Surgical --- Surgical Procedure, Urogenital --- Surgical Procedures, Urogenital --- Urogenital Surgical Procedure --- Laboratory Research --- Research Activities --- Research and Development --- Research Priorities --- Activities, Research --- Activity, Research --- Development and Research --- Priorities, Research --- Priority, Research --- Research Activity --- Research Priority --- Research, Laboratory --- Human Information Processing --- Information Processing, Human --- Investigative Technics --- Investigative Technic --- Investigative Technique --- Technic, Investigative --- Technics, Investigative --- Technique, Investigative --- Techniques, Investigative --- Experimental Medicine --- Investigational Medicine --- Investigative Medicine --- Research, Biomedical --- Research, Medical --- Medical Research --- Medicine, Experimental --- Medicine, Investigational --- Medicine, Investigative --- Philosophical Overview --- Hedonism --- Stoicism --- Overview, Philosophical --- Overviews, Philosophical --- Philosophical Overviews --- Philosophies --- General Social Development and Population --- Services, Health --- Health Service --- Service, Health --- Person --- Informal Social Control --- Control, Informal Social --- Controls, Informal Social --- Informal Social Controls --- Social Controls, Informal --- Critical Thinking --- Thinking Skills --- Thinking Skill --- Thinking, Critical --- Egoism --- Ethical Issues --- Metaethics --- Moral Policy --- Natural Law --- Situational Ethics --- Ethical Issue --- Ethics, Situational --- Issue, Ethical --- Issues, Ethical --- Law, Natural --- Laws, Natural --- Moral Policies --- Natural Laws --- Policies, Moral --- Policy, Moral --- Physically Disabled --- Handicapped --- People with Disabilities --- Persons with Disabilities --- Physically Challenged --- Physically Handicapped --- Disabilities, People with --- Disabilities, Persons with --- Disability, Persons with --- Disabled Person --- Disabled, Physically --- Handicapped, Physically --- People with Disability --- Person, Disabled --- Persons with Disability --- Persons, Disabled --- Law and legislation --- Legal status, laws, etc. --- Moral and ethical aspects --- Community Consent --- Third Party Consent --- Spousal Consent --- Community Consents --- Consent, Community --- Consent, Spousal --- Consent, Third Party --- Consent, Third-Party --- Consents, Community --- Population Control --- Ethical Theory --- Defamation --- Lawyers --- Public Policy --- Helsinki Declaration --- Bioethical Issues --- Ethics, Research --- Embryo Research --- Fetal Research --- Research Subjects --- Psychologic Processes --- Psychological Processes --- Phenomena, Psychological --- Processes, Psychologic --- Processes, Psychological --- Psychological Phenomenas --- Psychological Processe --- Social Justice --- Human Rights Abuses --- Guardian and ward --- Problem Solving --- Euthanasia --- Advance Directives --- Living Wills --- Treatment Refusal --- Disclosure --- Therapeutic Misconception --- Insanity Defense --- Comprehension --- Bioethics --- Professional ethics --- Nursing ethics --- Social medicine --- Patient Advocacy --- Truth Disclosure --- Behavior Control --- Mandatory Programs --- Informed Consent By Minors --- Proxy --- Tissue and Organ Harvesting --- Beginning of Human Life --- Human Characteristics --- Clinical Trials, Phase I as Topic --- Self Concept --- Professional Autonomy --- Paternalism --- General Surgery --- Animals, Laboratory --- Pharmacy Philosophy --- Pharmacy Philosophies --- Philosophies, Pharmacy --- Philosophy, Pharmacy --- Power (Psychology) --- Social Conformity --- Thought --- Thoughts --- Censorship, Research --- Rehabilitation Research --- Bedridden Persons --- Immobilization --- Sports for Persons with Disabilities --- Health Services for Persons with Disabilities --- Freedom of Religion --- Religious Freedom --- Right to Movement --- Freedom, Religious --- Freedoms, Religious --- Movement, Right to --- Movements, Right to --- Religion Freedom --- Religion Freedoms --- Religious Freedoms --- Right to Movements --- to Movement, Right --- to Movements, Right --- Collective Human Rights --- Linguistic Rights --- Right to Housing and Shelter --- Rights of Indigenous Peoples --- Human Rights, Collective --- Indigenous Peoples Rights --- Rights, Collective Human --- Rights, Linguistic --- Citizen Science --- Power, Psychological --- PHILOSOPHY/Ethics & Bioethics --- BIOMEDICAL SCIENCES/General