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

• Autore: Nichols Eve K
• Pubblicazione: Washington, D.C., : National Academy Press, 1991
• Edizione: 1st ed.
• Descrizione fisica: 1 online resource (83 p.)
• Disciplina: 362.1/969792/00973
• Soggetto topico: AIDS (Disease) - Chemotherapy - Social aspects - United States; Pharmacology, Experimental - Social aspects - United States; HIV infections - Chemotherapy - Social aspects - United States
• Note generali: Bibliographic Level Mode of Issuance: Monograph
• Nota di bibliografia: Includes bibliographical references.
• Nota di contenuto: 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.
• Titolo autorizzato: Expanding access to investigational therapies for HIV infection and AIDS
• ISBN: 1-280-20356-0; 9786610203567; 0-309-58336-5; 0-585-15547-X
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910806896003321
• Lo trovi qui: Univ. Federico II