Clinical Trials Administrator Archives – December 1, 2010
December 1, 2010
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Unethical Guatemalan study may undermine recruitment, trust
Research sites that work with minority, international, or vulnerable populations should be particularly sensitive to continuing fall-out from recent revelations of strikingly unethical behavior by U.S. researchers in Guatemala in the 1940s. -
Earning respect, trust in international settings
No one can predict yet whether or not the growing infamy of the Guatemalan syphilis study results in enrollment problems for researchers engaged in international research. -
Compliance Corner: Producing best-practices in research compliance
Academic researchers spend a large chunk of their time on paperwork. Regulatory and institutional burdens could seem overwhelming. -
Discerning between disease, drug reactions
One of the chief problems with adverse event reports is these often cast a net so wide that many disease symptoms are swept up with the reports. This particularly is an issue with oncology clinical trials. -
Using wireless bio monitoring in studies
Investigators at the University of Southern California in Los Angeles, CA, have found an electronic solution to the problem of collecting accurate data about subjects' daily activities. -
Not-for-cause audits can keep program on track
Quality assessments can be a good strategy for finding compliance problems that otherwise would fly under the radar. These not-for-cause audits require some staffing resources, but if handled efficiently they uncover problematic trends and bad habits before an issue becomes serious.