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Clinical trial professionals and investigators should reconsider the inclusion/exclusion criteria and other factors to meet the needs of their study participants, an expert suggests.
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Knowing that an investigator has a financial interest in a clinical trial doesn't substantially affect people's willingness to participate, according to a study that surveyed 470 people about their reaction to informed consent documents that detailed such interests.
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A recent study of an instrument for assessing decisional capacity in patients with Alzheimer's disease shows that it's a reliable tool for determining whether those patients are competent to give their own consent for research.
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The new IRB Advisor pilot program at Rutgers, The State University of New Jersey in New Brunswick, NJ, resulted in a reduction in protocol submissions that had to be returned to investigators, according to the IRB director.
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It's just about a given that informed consent documents making their way to the IRB for approval will need to be revised for comprehension and readability. Investigators and sponsors tend to include long sentences and paragraphs and technical jargon that leads the MEGO syndrome "my eyes glaze over," says Stewart A. Laidlaw, PhD, an associate vice president for compliance at the Los Angeles Biomedical Research Institute at the Harbor-UCLA Medical Center (LA BioMed) in Torrance, CA.
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Quality assurance programs for clinical trials do more than improve the data coming out of studies and the validity of the results.
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Zaman et al randomized 340 pregnant Bangladeshi women to receive either inactivated influenza or pneumococcal polysaccharide (control group) vaccine.
