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

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

Detalles Bibliográficos
Autor principal: Nichols, Eve K. (-)
Autor Corporativo: Roundtable for the Development of Drugs and Vaccines against AIDS (Institute of Medicine) (-)
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, D.C. : National Academy Press 1991.
Edición:1st ed
Materias:
AIDS (Disease) > Chemotherapy > Social aspects > United States > Congresses.
Pharmacology, Experimental > Social aspects > United States > Congresses.
HIV infections > Chemotherapy > Social aspects > United States > Congresses.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820336706719
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 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.

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