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Both the National Institutes of Health (NIH) and the FDA have taken action in the past decade to increase pediatric participation in clinical trials. In fact, if a trial is supported by NIH and addresses a disease seen in both adults and children, researchers must provide a compelling reason if they plan not to include children.
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As informed consent documents continue to get longer and more complex, be prepared to challenge old ways of thinking even when using print.
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Electronic tools can be intimidating. They can be costly. Often they take us out of our comfort zones and challenge processes we have grown accustomed to.
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As part of the discussion of how budgets can influence subject enrollment and retention, Jeffrey Adelglass, MD, CEO, Research Across America, Dallas, TX, ran through his Top 10 list of budget busters David Letterman style.
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Whether you're on the sponsor side or the clinical site side, you're probably acutely aware of two trends in clinical research: Contract negotiation and study start-up are big stumbling blocks in the advancement of research.
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Needlesticks a problem some may have thought solved by needle safety devices remain a top concern among nurses.
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Roche Laboratories, Inc. has updated their package insert for their protease inhibitor, saquinavir (Invirase) to include the following drug interaction information and include new warnings regarding coadministration of saquinavir/ritonavir and digoxin (used in the treatment of various cardiac conditions).
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Episodic, unexplained false positive results with an oral fluid rapid HIV test, have resulted in changed protocols in some clinics and an ongoing investigation by the Centers for Disease Control and Prevention.