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.

Contents

• ROUNDTABLE FOR THE DEVELOPMENT OF DRUGS AND VACCINES AGAINST AIDS
• Preface
• Expanding Access to Investigational Therapies March 12–13, 1990 Program
• 1. Historical Perspective
  • Early Development of Expanded Access
  • The Advent of AIDS
• 2. Rights and Responsibilities
  • Freedom of Choice
  • Informed Consent
  • Competing Rights
  • Institutional Review Boards
  • New Attitudes
• 3. Evaluation of Expanded Access Programs
  • Treatment Investigational New Drugs
  • Potential Risks
  • 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
  • Data from the Parallel Track
• 5. Drug Innovation and the Pharmaceutical Industry
  • Time to Commercialization
  • Direct Costs of Expanded Access
  • Product Liability
• 6. Third-Party Payers
  • Blue Cross and Blue Shield
  • Health Insurance Association of America
  • Health Care Financing Administration
  • Resources for Clinical Investigation
• 7. Improving Access to Care
  • People of Color
  • Women
  • The Pediatric Population

The Roundtable is supported by the American Foundation for AIDS Research, the Merck Company Foundation, the Pharmaceutical Manufacturers Association, the U.S. Army, the U.S. Public Health Service, and the U.S. Department of Veterans Affairs.

The report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

This conference summary was written by Eve Nichols for the Institute of Medicine's Roundtable for the Development of Drugs and Vaccines Against AIDS, chaired by Harold Ginsberg and Sheldon Wolff and directed by Robin Weiss. The document reports major themes of the conference discussions; these themes, however, do not represent policy statements by the Institute of Medicine.

The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an advisor to the federal government, and its own initiative in identifying issues of medical care, research, and education.