Expanding Access to Investigational Therapies for HIV Infection and AIDS

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 Capabilitiesexpedited 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 Trialsthe 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 Liabilityconcerns 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 Populationscientific Issues; Social Issues Eve Nichols [writer] ; Roundtable For The Development Of Drugs And Vaccines Against Aids, Institute Of Medicine. Includes Bibliographical References. Electronic Reproduction. [s.l.] : Hathitrust Digital Library, 2010. Miaahdl Master And Use Copy. Digital Master Created According To Benchmark For Faithful Digital Reproductions Of Monographs And Serials, Version 1. Digital Library Federation, December 2002. Http://purl.oclc.org/dlf/benchrepro0212 Miaahdl English. Digitized 2010 Hathitrust Digital Library Committed To Preserve Miaahdl Pda