Specific advocate guidelines are needed for the protection of children in state custody who are potential research subjects in trials that would expose them to greater-than-minimal risk but also hold the prospect of direct benefit.
Physicians are cautioned that the two obstacles to reforming post-marketing clinical trials are the FDA's reluctance to revisit past approvals and its inability to enforce pharmaceutical companies' commitment to conduct Phase IV trials.
The conventional quality-adjusted life years approach to resource allocation has greater societal value if it is distributed among many rather than concentrated on a few, assuming that severity of illness is the same.
Raphael P. Viscidi, MD and Keerti V. Shah, MD, DrPH
The arguments for mandatory vaccination with human papillomavirus vaccine differs from the justification for mandatory use of vaccines that protect against more easily transmitted diseases.
Two physicians give an overview of the iPledge program and discuss the problematic aspects of the program for physicians who prescribe isotretinoin and their patients.