Expanding Access to Investigational Therapies for HIV Infection and AIDS
Seiten
1991
National Academies Press (Verlag)
978-0-309-04490-5 (ISBN)
National Academies Press (Verlag)
978-0-309-04490-5 (ISBN)
The call for a "parallel track" for AIDS drug development has sparked controversy within the scientific community. Questions have arisen about the risks to patients of such a plan. This volume summarizes a conference hosted by the Institute of Medicine that illuminated these issues.
The call for a "parallel track" for AIDS drug development—a proposal that would allow the early distribution of AIDS drugs to large numbers of patients in parallel with the conventional clinical trials that assess the drugs' safety and efficacy—has sparked controversy within the scientific community. Questions have arisen about the risks to patients of such a plan, about its potential effect on the successful completion of standard controlled trials, and about whether the parallel track will generate useful data.
Larger questions have also been raised about whether the parallel track heralds fundamental changes in the philosophy underlying drug regulation in the United States, about the costs and financing of investigational therapies and associated medical costs, and about the role of expanded access mechanisms for drugs in reaching those whose health care is generally inadequate. This volume summarizes a conference hosted by the Institute of Medicine that illuminated these issues.
Table of Contents
FRONT MATTER
CONFERENCE PROGRAM
1 HISTORICAL PERSPECTIVE
2 RIGHTS AND RESPONSIBILITIES
3 EVALUATION OF EXPANDED ACCESS PROGRAMS
4 CREATIVITY IN CLINICAL TRIALS
5 DRUG INNOVATION AND THE PHARMACEUTICAL INDUSTRY
6 THIRD-PARTY PAYERS
7 IMPROVING ACCESS TO CARE
The call for a "parallel track" for AIDS drug development—a proposal that would allow the early distribution of AIDS drugs to large numbers of patients in parallel with the conventional clinical trials that assess the drugs' safety and efficacy—has sparked controversy within the scientific community. Questions have arisen about the risks to patients of such a plan, about its potential effect on the successful completion of standard controlled trials, and about whether the parallel track will generate useful data.
Larger questions have also been raised about whether the parallel track heralds fundamental changes in the philosophy underlying drug regulation in the United States, about the costs and financing of investigational therapies and associated medical costs, and about the role of expanded access mechanisms for drugs in reaching those whose health care is generally inadequate. This volume summarizes a conference hosted by the Institute of Medicine that illuminated these issues.
Table of Contents
FRONT MATTER
CONFERENCE PROGRAM
1 HISTORICAL PERSPECTIVE
2 RIGHTS AND RESPONSIBILITIES
3 EVALUATION OF EXPANDED ACCESS PROGRAMS
4 CREATIVITY IN CLINICAL TRIALS
5 DRUG INNOVATION AND THE PHARMACEUTICAL INDUSTRY
6 THIRD-PARTY PAYERS
7 IMPROVING ACCESS TO CARE
Roundtable for the Development of Drugs and Vaccines Against AIDS, Institute of Medicine
1 FRONT MATTER; 2 CONFERENCE PROGRAM; 3 1 HISTORICAL PERSPECTIVE; 4 2 RIGHTS AND RESPONSIBILITIES; 5 3 EVALUATION OF EXPANDED ACCESS PROGRAMS; 6 4 CREATIVITY IN CLINICAL TRIALS; 7 5 DRUG INNOVATION AND THE PHARMACEUTICAL INDUSTRY; 8 6 THIRD-PARTY PAYERS; 9 7 IMPROVING ACCESS TO CARE
| Erscheint lt. Verlag | 1.2.1991 |
|---|---|
| Verlagsort | Washington |
| Sprache | englisch |
| Maße | 152 x 229 mm |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
| Studium ► Querschnittsbereiche ► Infektiologie / Immunologie | |
| ISBN-10 | 0-309-04490-1 / 0309044901 |
| ISBN-13 | 978-0-309-04490-5 / 9780309044905 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
| Haben Sie eine Frage zum Produkt? |
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