Curbing industry sponsor's incentive to design post-approval trials that are suboptimal for informing prescribers but more likely than optimal designs to yield favorable results.

Falit, Benjamin P

Curbing industry sponsor's incentive to design post-approval trials that are suboptimal for informing prescribers but more likely than optimal designs to yield favorable results. [electronic resource] - Seton Hall law review 2007 - 969-1049 p. digital

Publication Type: Journal Article

0586-5964


Clinical Protocols
Clinical Trials, Phase IV as Topic--economics
Complementary Therapies
Cost-Benefit Analysis
Dose-Response Relationship, Drug
Drug Approval
Drug Industry--economics
Drug-Related Side Effects and Adverse Reactions
Epidemiologic Factors
Financial Support
Formularies as Topic
Government Regulation
Humans
Information Services
Insurance Coverage
Insurance, Pharmaceutical Services
Motivation
Organizational Policy
Outcome and Process Assessment, Health Care
Patient Selection
Practice Patterns, Physicians'
Private Sector
Product Surveillance, Postmarketing
Public Sector
Publication Bias
Quality Control
Racial Groups
Research Design
Severity of Illness Index
Time Factors
United States
United States Food and Drug Administration