UID:
edocfu_9958103240402883
Format:
1 online resource (83 p.)
Edition:
1st ed.
ISBN:
1-280-20356-0
,
9786610203567
,
0-309-58336-5
,
0-585-15547-X
Note:
Bibliographic Level Mode of Issuance: Monograph
,
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.
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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.
,
English
Additional Edition:
ISBN 0-309-04490-1
Language:
English
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