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.
- 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
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