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In a retrospective review of 105 patients treated exclusively with anti-Helicobacter therapy for locally confined gastric MALT lymphoma initial complete responses were achieved in 75% of cases and at a median follow-up of 6.3 years, disease relapse had occurred in only 13.
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Clopidogrel and proton pump inhibitors; adverse events with tamsulosin after cataract surgery; new guidelines for persistent pain in the elderly; and FDA Actions.
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The first step to obtaining staff buy-in for your standard operating procedures (SOPs) is to include staff in the process of writing the SOPs and to make sure the final document is clear, concise, and useful.
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Investigators weighing the risks and benefits of a randomized clinical trial might try using a new statistical concept that offers consistency and clarity to their decision-making process.
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Community education and informed consent about an investigational treatment will be a more intense process when it involves parents of seriously ill children.
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For many professionals in the clinical trial world, creating standard operating procedures (SOPs) is another box to check off. But if they look at it as a low priority duty, then they might be missing an opportunity to improve their organization's quality by using well prepared and regularly updated SOPs, experts say.
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With research institutions increasingly facing vigorous regulatory scrutiny, it is a good idea to provide investigators with support in areas where they might have issues. One such area involves applications for investigational new drugs (INDs) and investigational device exemptions (IDEs).
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Clinical trial audits typically lead to better research compliance, but the best strategy might be to look specifically for systemic problems.
