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Expanding access to investigational therapies for HIV infection and AIDS [[electronic resource] ] : March 12-13, 1990, conference summary / / Eve Nichols [writer] ; Roundtable for the Development of Drugs and Vaccines against AIDS, Institute of Medicine
| Expanding access to investigational therapies for HIV infection and AIDS [[electronic resource] ] : 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 |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1991 |
| 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 |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-20356-0
9786610203567 0-309-58336-5 0-585-15547-X |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910456241403321 |
Nichols Eve K
|
||
| Washington, D.C., : National Academy Press, 1991 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Expanding access to investigational therapies for HIV infection and AIDS [[electronic resource] ] : March 12-13, 1990, conference summary / / Eve Nichols [writer] ; Roundtable for the Development of Drugs and Vaccines against AIDS, Institute of Medicine
| Expanding access to investigational therapies for HIV infection and AIDS [[electronic resource] ] : 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 |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1991 |
| 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 |
| ISBN |
1-280-20356-0
9786610203567 0-309-58336-5 0-585-15547-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910778501803321 |
|
Nichols Eve K
|
||
| Washington, D.C., : National Academy Press, 1991 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
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
| 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 |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1991 |
| 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 |
| ISBN |
1-280-20356-0
9786610203567 0-309-58336-5 0-585-15547-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| 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. |
| Record Nr. | UNINA-9910806896003321 |
|
Nichols Eve K
|
||
| Washington, D.C., : National Academy Press, 1991 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||