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Author Nichols, Eve K.

Title 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
Published Washington, D.C. : National Academy Press, 1991

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Description 1 online resource (viii, 73 pages)
Contents ""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 CapabilitiesExpedited 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 TRIALSTHE 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 LIABILITYConcerns 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 POPULATIONScientific Issues -- Social Issues
Bibliography Includes bibliographical references
Notes Master and use copy. Digital master created according to Benchmark for Faithful Digital Reproductions of Monographs and Serials, Version 1. Digital Library Federation, December 2002. http://purl.oclc.org/DLF/benchrepro0212 MiAaHDL
English
Print version record
digitized 2010 HathiTrust Digital Library committed to preserve MiAaHDL pda
Subject 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.
Research.
Risk.
HIV infections.
Risk assessment.
Ethics committees.
Liberty.
Information services.
Women.
Medical care.
Informed consent (Medical law)
Minorities.
Pharmaceutical industry.
Methodology.
Economics.
Human rights.
Sociology.
Probabilities.
Industries.
Slow virus diseases.
Non-governmental organizations.
Science.
National health services.
Drugs.
Health services administration.
Communication.
Immunological deficiency syndromes.
Risk management.
Lentivirus infections.
Social sciences.
Insurance.
Therapeutics.
Medical care -- Quality control.
Statistics.
Public health.
Physical sciences.
Humanities.
Sexually transmitted diseases.
Virus diseases.
Misinformation.
Ethics Committees, Research
Government Regulation
Health Services Accessibility
Personal Autonomy
Public Policy
Random Allocation
Research Design
Social Control, Formal
HIV Seropositivity
Acquired Immunodeficiency Syndrome
Child
Federal Government
Human Experimentation
Information Dissemination
Patient Selection
Research
Risk
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
Immunologic Deficiency Syndromes
Risk Management
Epidemiologic Measurements
Lentivirus Infections
Social Sciences
Information Science
Biomedical Research
Insurance
Investigative Techniques
Therapeutics
Health Care Quality, Access, and Evaluation
Quality Assurance, Health Care
Technology, Industry, and Agriculture
Statistics as Topic
Professional Practice
Public Health
Natural Science Disciplines
Health Care Evaluation Mechanisms
Named Groups
Financing, Organized
Humanities
Sexually Transmitted Diseases
Chemicals and Drugs
Epidemiologic Methods
Virus Diseases
Policy
Psychiatry and Psychology
children (people by age group)
federal government.
research (function)
governments (administrative bodies)
risk assessment.
freedom.
minorities.
methodology.
economics.
sociology.
probability.
sciences (philosophy)
risk management.
social sciences.
insurance.
public health.
physical sciences.
humanities.
women (female humans)
science (modern discipline)
treating (health care function)
statistics.
MEDICAL -- AIDS & HIV.
HEALTH & FITNESS -- Diseases -- AIDS & HIV.
Pharmacology, Experimental -- Social aspects
Infections à VIH.
Syndrome d'immunodéficience acquise.
United States
Genre/Form proceedings (reports)
Conference papers and proceedings
Conference papers and proceedings.
Actes de congrès.
Form Electronic book
Author Roundtable for the Development of Drugs and Vaccines against AIDS (Institute of Medicine)
ISBN 058515547X
9780585155470