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After 7.3 years of treatment and follow-up, a combination pill of folic acid, vitamin B6 and vitamin B12 did not reduce a combined endpoint of total cardiovascular events among high-risk women despite significant homocysteine lowering.
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Duloxetine is the first serotonin norepinephrine reuptake inhibitor (SNRI) to be approved for the treatment of fibromyalgia.
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There have been no major therapeutic steps added for the management of acute gouty arthritis (AGA) for over 30 years.
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To achieve success in pediatric research, investigators need to reach and convince one vital group of people parents, who must decide whether to expose their children to the inconveniences and even potential risk of research participation.
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IRBs ordinarily are concerned with studies that test a specific drug or intervention on patients, students, or other end-users of health care services.
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Research institutions and officials increasingly are finding that extra layers of oversight are better than too few. While IRBs once were the only organizations to oversee human subjects protection of research participants, now there are additional committees and offices assisting with this task.
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The FDA briefly suspended the ability of an independent IRB to conduct expedited reviews after raising concerns over the conduct of one such review.
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One of the most important ways IRBs can improve the informed consent process is by encouraging investigators to confirm comprehension for their potential subjects, an expert suggests.