Expanding access to investigational therapies for HIV infection and AIDS : March 12-13, 1990, conference summary / Eve Nichols [writer] ; Roundtable for the Development of Drugs and Vaccines against AIDS, Institute of Medicine.
Material type: TextPublication details: Washington, D.C. : National Academy Press, 1991.Description: 1 online resource (viii, 73 pages)Content type:- text
- computer
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- 058515547X
- 9780585155470
- AIDS (Disease) -- Chemotherapy -- Social aspects -- United States -- Congresses
- Pharmacology, Experimental -- Social aspects -- United States -- Congresses
- HIV infections -- Chemotherapy -- Social aspects -- United States -- Congresses
- Institutional review boards (Medicine)
- Health services accessibility
- Social control
- AIDS (Disease)
- Children
- Federal government
- Human experimentation in medicine
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- HIV infections
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- Patient Selection
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- Socioeconomic Factors
- Government
- HIV Infections
- Insurance, Health
- Risk Assessment
- Ethics Committees
- Freedom
- Information Services
- Therapeutic Human Experimentation
- Women
- Clinical Trials as Topic
- Patient Care
- Vulnerable Populations
- Informed Consent
- Research Subjects
- Minority Groups
- Drugs, Investigational
- Drug Industry
- Financial Support
- Health Care Economics and Organizations
- Methods
- Economics
- Human Rights
- Sociology
- Probability
- Industry
- Principle-Based Ethics
- Slow Virus Diseases
- Ethics
- Epidemiologic Study Characteristics as Topic
- Professional Staff Committees
- Organizations
- Evaluation Studies as Topic
- Psychological Phenomena and Processes
- Jurisprudence
- Social Control Policies
- Delivery of Health Care
- Patient Rights
- Science
- Persons
- Health Services
- Epidemiologic Research Design
- Pharmaceutical Preparations
- Patient Care Management
- Population Characteristics
- Communication
- Age Groups
- Sexually Transmitted Diseases, Viral
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- Risk Management
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- Social Sciences
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- Médicaments contre le sida -- Aspect social -- États-Unis -- Congrès
- Pharmacologie expérimentale -- Aspect social -- États-Unis -- Congrès
- Infections à VIH -- Chimiothérapie -- Aspect social -- États-Unis -- Congrès
- Comités d'éthique de la recherche
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- Assurance-maladie
- Évaluation du risque
- Comités d'éthique
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- Gestion du risque
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- Soins médicaux -- Qualité -- Contrôle
- Statistiques
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- children (people by age group)
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- governments (administrative bodies)
- risk assessment
- freedom
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- methodology
- economics
- sociology
- probability
- sciences (philosophy)
- risk management
- social sciences
- insurance
- public health
- physical sciences
- humanities
- MEDICAL -- AIDS & HIV
- HEALTH & FITNESS -- Diseases -- AIDS & HIV
- Pharmacology, Experimental -- Social aspects
- United States
- Infections à VIH
- Syndrome d'immunodéficience acquise
- 362.1/969792/00973 20
- RC607.A26 N53 1991eb
- WD 308
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""Expanding Access to Investigational Therapies for HIV Infection and AIDS""; ""Copyright""; ""PREFACE""; ""Contents""; ""EXPANDING ACCESS TO INVESTIGATIONAL THERAPIES FOR HIV INFECTION AND AIDS""; ""Expanding Access to Investigational Therapies March 12�13, 1990 Program""; ""1 HISTORICAL PERSPECTIVE""; ""EARLY DEVELOPMENT OF EXPANDED ACCESS""; ""Drug Amendments of 1962""; ""Access for Therapeutic Purposes""; ""Growing Confusion""; ""Modern Clinical Trials (Non-AIDS Drugs)""; ""THE ADVENT OF AIDS""; ""Broadening Participation""; ""Accelerating the Pace of Drug Development""
""Improving Response Capabilities""""Expedited Development""; ""Expanded Access""; ""Treatment Investigational New Drugs""; ""Parallel Track""; ""2 RIGHTS AND RESPONSIBILITIES""; ""FREEDOM OF CHOICE""; ""INFORMED CONSENT""; ""Information Resources""; ""Access""; ""Primary Care""; ""Difficult Choices""; ""COMPETING RIGHTS""; ""INSTITUTIONAL REVIEW BOARDS""; ""NEW ATTITUDES""; ""3 EVALUATION OF EXPANDED ACCESS PROGRAMS""; ""TREATMENT INVESTIGATIONAL NEW DRUGS""; ""POTENTIAL RISKS""; ""Examples from the Past""; ""The Target Population""; ""Safety Data""
""IMPACT ON CONVENTIONAL RANDOMIZED TRIALS""""THE PARALLEL TRACK EXPERIMENT""; ""4 CREATIVITY IN CLINICAL TRIALS""; ""THE CHANGING ENVIRONMENT""; ""CONVENTIONAL TRIALS""; ""PREFERENCE TRIALS""; ""LARGE, SIMPLE RANDOMIZED TRIALS""; ""Physician Participation""; ""Quality Control""; ""DATA FROM THE PARALLEL TRACK""; ""Efficacy Data""; ""Safety Data and Related Information""; ""Expectations""; ""5 DRUG INNOVATION AND THE PHARMACEUTICAL INDUSTRY""; ""TIME TO COMMERCIALIZATION""; ""DIRECT COSTS OF EXPANDED ACCESS""; ""Manpower Needs""; ""Drug Costs""; ""The Small Manufacturer""
""PRODUCT LIABILITY""""Concerns Specific to the Parallel Track""; ""Potential Solutions""; ""6 THIRD-PARTY PAYERS""; ""BLUE CROSS AND BLUE SHIELD""; ""HEALTH INSURANCE ASSOCIATION OF AMERICA""; ""HEALTH CARE FINANCING ADMINISTRATION""; ""Medicaid""; ""State Discretion""; ""Patient Care Costs""; ""Medicare""; ""RESOURCES FOR CLINICAL INVESTIGATION""; ""7 IMPROVING ACCESS TO CARE""; ""PEOPLE OF COLOR""; ""Resource Considerations""; ""Suspicion""; ""Informed Consent""; ""WOMEN""; ""The Gender Perspective""; ""Risk Factors""; ""Protocol Development""; ""Women as Vectors""; ""A New Approach""
""THE PEDIATRIC POPULATION""""Scientific Issues""; ""Social Issues""
English.
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