04530nam 2200637 a 450 991080689600332120240416232643.01-280-20356-097866102035670-309-58336-50-585-15547-X(CKB)110986584751068(OCoLC)559734779(CaPaEBR)ebrary10054979(SSID)ssj0000151940(PQKBManifestationID)11146947(PQKBTitleCode)TC0000151940(PQKBWorkID)10320453(PQKB)10189406(MiAaPQ)EBC3375988(Au-PeEL)EBL3375988(CaPaEBR)ebr10054979(CaONFJC)MIL20356(OCoLC)923259948(EXLCZ)9911098658475106819910211d1991 uy 0engurcn|||||||||txtccrExpanding 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 Medicine1st ed.Washington, D.C. National Academy Press19911 online resource (83 p.) Bibliographic Level Mode of Issuance: Monograph0-309-04490-1 Includes bibliographical references.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.AIDS (Disease)ChemotherapySocial aspectsUnited StatesCongressesPharmacology, ExperimentalSocial aspectsUnited StatesCongressesHIV infectionsChemotherapySocial aspectsUnited StatesCongressesAIDS (Disease)ChemotherapySocial aspectsPharmacology, ExperimentalSocial aspectsHIV infectionsChemotherapySocial aspects362.1/969792/00973Nichols Eve K1626963Roundtable for the Development of Drugs and Vaccines against AIDS (Institute of Medicine)MiAaPQMiAaPQMiAaPQBOOK9910806896003321Expanding access to investigational therapies for HIV infection and AIDS3963301UNINA