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Expanding access to investigational therapies for HIV infection and AIDS : March 12-13, 1990, conference summary /

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Nichols, Eve K.
Autor Corporativo: Roundtable for the Development of Drugs and Vaccines against AIDS (Institute of Medicine)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington, D.C. : National Academy Press, 1991.
Temas:
Acceso en línea:Texto completo
Tabla de Contenidos:
  • ""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 12â€?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