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It's good timing to improve your research compliance program now that billions more dollars in federal funding from the health care reform and stimulus package continue to be pumped into the research economy. Such money brings increased regulatory scrutiny, and this means clinical trial (CT) sites will need to make certain they are following all rules.
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Clinical trials directors should take reasonable steps to manage their organization's risk in human subjects research. It's not wise to assume that someone else is taking care of this issue, an expert advises.
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Assessing a protocol's feasibility should be a top priority for clinical trial sites. And it's a good strategy to have a thorough feasibility process in place.
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The current economy should be enough to convince clinical research (CR) sites that they need better strategies to handle the rollercoaster ride of the research business cycle if they want to survive and thrive for the long term.
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On April 27, 2010, FDA approved a new dosing regimen for lopinavir/ritonavir (Kaletra®) tablets and oral solution.
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An open-label, randomized, controlled trial of early vs. delayed initiation of HAART was conducted in 642 patients with active TB and HIV infection in Durban, South Africa.
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The good news is that HIV advocacy groups, clinicians, and others haven't seen so many HIV/AIDS program federal budget increases since the 1990s. The bad news is that it might be too little, too late in a recessionary environment in which state budgets are forcing draconian cuts.
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In the United States, women and teen girls accounted for more than one-fourth of all new HIV/AIDS diagnoses in 2007 and more than 93,900 cumulative deaths from AIDS. Black women are at heightened risk. The incidence rate of new diagnoses in black women is almost 15 times higher than that of white women, according to statistics compiled by the Centers for Disease Control and Prevention.
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The final version of the federal HIV/AIDS program budget for fiscal year 2010 is about as close to what AIDS advocates have wanted as they've seen in nearly a decade.