Skip to main content

Currently Skimming:

1 Setting the Context
Pages 1-8

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 2...
... An implementation strategy for science-based assessment should open federal lines of communication, minimize duplication of requirements, and use peer review for guidance and approvals. Such a strategy would emphasize safety in premarket conditional approvals, monitor clinical outcomes for decisions on retention of postmarket approval, and include federal agency support for research on science-based testing methods.
From page 3...
... stent strut inflammation is influenced by medial disruption and is associated with restenosis; (2) healing is much slower in human atherosclerotic arteries than in normal animal coronary arteries; (3)
From page 4...
... The existence of a panoply of scientifically grounded tests undertaken to prove the safety and effectiveness of a medical technology comports with societal expectations and is perceived to be a means of protecting patients' interests. The existence of such tests provides a sense of comfort due to the perception that risk has been minimized.
From page 5...
... For breakthrough innovations addressing unmet clinical needs, a considered balance between a rigorous and relatively inflexible science-based testing approach and judgment-based empiricism may facilitate the more rapid introduction of safe and effective technologies. As technologies become more mature, the importance of science-based testing increases to help ensure favorable performance comparisons, quality, and consistency.
From page 6...
... While sessile bacterial cells release antigens and stimulate the production of antibodies, the antibodies are not effective in killing bacteria in biofilms and may cause damage to surrounding tissues. Even in individuals with excellent cellular and humoral immune reactions, biofilm infections are rarely resolved by the host defense mechanisms.
From page 7...
... An understanding of the underlying biology of biofilm formation can provide the information needed to begin development of more effective modalities and treatments for medical devices. Such treatments could include specific signal inhibitors or drug delivery mechanisms, as well as combined therapies to target both sessile bacteria through specific signaling and planktonic bacteria through antibiotic/metabolic attack.
From page 8...
... Regarding conflicts of interest in clinical research, there has recently been a growing recognition that the scientific integrity of clinical testing is sometimes threatened by interests that are antagonistic to professional or ethical responsibility and that are substantial enough that they might reasonably affect judgments or actions. These conflicts are frequently not recognized -- in fact, are often denied -- and inadequate attention is given to the need to prevent or manage them.


This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More information on Chapter Skim is available.