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.
Institute of Medicine. 1991. Expanding Access to Investigational Therapies for HIV Infection and AIDS. Washington, DC: The National Academies Press. https://doi.org/10.17226/1778.
Chapters | skim | |
---|---|---|
FRONT MATTER | i-x | |
CONFERENCE PROGRAM | 1-4 | |
1 HISTORICAL PERSPECTIVE | 5-18 | |
2 RIGHTS AND RESPONSIBILITIES | 19-26 | |
3 EVALUATION OF EXPANDED ACCESS PROGRAMS | 27-34 | |
4 CREATIVITY IN CLINICAL TRIALS | 35-44 | |
5 DRUG INNOVATION AND THE PHARMACEUTICAL INDUSTRY | 45-52 | |
6 THIRD-PARTY PAYERS | 53-62 | |
7 IMPROVING ACCESS TO CARE | 63-73 |
The Chapter Skim search tool presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter. You may select key terms to highlight them within pages of each chapter.
The National Academies Press (NAP) has partnered with Copyright Clearance Center's Marketplace service to offer you a variety of options for reusing NAP content. Through Marketplace, you may request permission to reprint NAP content in another publication, course pack, secure website, or other media. Marketplace allows you to instantly obtain permission, pay related fees, and print a license directly from the NAP website. The complete terms and conditions of your reuse license can be found in the license agreement that will be made available to you during the online order process. To request permission through Marketplace you are required to create an account by filling out a simple online form. The following list describes license reuses offered by the NAP through Marketplace:
Click here to obtain permission for the above reuses. If you have questions or comments concerning the Marketplace service, please contact:
Marketplace Support
International +1.978.646.2600
US Toll Free +1.855.239.3415
E-mail: support@copyright.com
marketplace.copyright.com
To request permission to distribute a PDF, please contact our Customer Service Department at customer_service@nap.edu.