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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 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""