Clinical Trials Administrator Archives – October 1, 2009
October 1, 2009
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FDA ruling may increase clinical trials
The Food and Drug Administration's (FDA's) new final rule on expanded access to investigational drugs has the potential to result in increasing clinical trials through its advocacy of intermediate-size patient populations. -
CER ethics controversy spills over to health debate
It was a foreshadowing of a health care reform debate that has one side arguing that living wills are suicide pacts between patients and clinicians. -
CER used effectively overseas for many years
Comparative effectiveness research (CER) is gaining momentum in the United States, but it's been used for years in other countries. -
Linking databases has value, can raise regulatory questions
Several national forces are driving energy into research that heavily relies on clinical data registries. The federal stimulus money that's available to hospitals that upgrade their electronic database technology and for comparative effectiveness research is a chief driver of this trend. -
Use Web delivery for research intervention
Researchers seeking to change adolescent girls' health behavior found that using a Web site could enhance outcomes, a recent study shows. -
KISS rule: Investigators need to keep it simple
Researchers still haven't developed the optimal way to give study participants information they want to hear during the informed consent process, an expert says.