Challenges for the FDA The Future of Drug Safety: Workshop Summary (2007) / Chapter Skim
Currently Skimming:
6 Conducting Confirmatory Drug Safety and Efficacy Studies
6 Conducting Confirmatory Drug Safety and Efficacy Studies
Pages 49-53
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 49... ...
Whereas the focus of the previous session was on the capacity of a linked 1This chapter is based on the presentations of Dr. Dieck and Robert Califf, Director, Duke Translational Medicine Institute, Professor of Medicine, and Vice Chancellor for Clinical and Translational Research, Duke University Medical Center.
|
From page 50... ...
Krall and McClellan about what will happen if public–private partnerships and the associated lower costs are not achieved. If the various stakeholders developed their own systems, the resulting bureaucracy would be highly complex; moreover, it would be dangerous to have every health care organization publicizing results and making coverage decisions based on its own limited datasets.
|
From page 51... ...
The partnership could also deal proactively with the design of studies intended to clarify putative safety signals. These studies could include larger surveillance studies, more focused prospective registries, pragmatic trials, or mechanistic laboratory-based studies to determine biological mechanisms.
|
From page 52... ...
, which calls for a distinct comparative effectiveness entity that would set priorities and be directed largely toward postapproval activities, systematic reviews, and observational studies. He responded that he would not want to see different structures built to address comparative effectiveness and postmarket safety because the two functions have so much in common; rather, he would hope that there would be "conceptually one effort, but tailored for different purposes." Dr.
|
From page 53... ...
CONDUCTING CONFIRMATORY DRUG SAFETY AND EFFICACY STUDIES many separate groups. The questioner then emphasized the importance of including this perspective in other dialogues on this issue because once stakeholders start to gather resources and evaluate proposals, it will be more difficult to introduce a larger, broader agenda.
|
Key Terms
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.