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From losing money to bonuses in one year.
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The Food and Drug Administrations Center for Drug Evaluation and Research (FDA CDER) has issued a draft guidance to make it easier for development and testing of Alzheimers treatments in patients at an early stage of the disease.
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Research institutions with concerns about an IRBs preparation for reviews and regulatory compliance could learn a few lessons on how to assess their performance and improve any problems from the experience of the IRB at WellSpan Health in York, PA.
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A study conducted by the Clinical Trials Transformation Initiative (CTTI) identified some of the barriers IRBs may face when choosing a central IRB for multicenter studies.
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What IRBs and the research ethics community commonly believe is evidence of therapeutic misconception among research participants often is the result of misinterpretation by the experts, a researcher says.
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IRBs run on data and paper and lots of it. Some organizations may find themselves running out of space to store the reams of paper that are needed to catalog the scores of research and submission data. This has led some IRBs to look for alternative methods of data storage. But an IRB cant live without paper or can it?
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Drugmaker GlaxoSmithKline (GSK) has announced its intentions to start publishing clinical study reports (CSRs) and clinical trial results in an effort for increased transparency, making it the first major drug company to do so.
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In days not so long ago, when all IRB members received heavy stacks of paper packets containing protocol submissions before each meeting, research institutions and regulatory compliance officials never questioned whether they would read the work before meetings. It was assumed they would be well-prepared for discussions.
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It is vital for providers caring for pediatric patients not to jump to a diagnosis just because it is in the Diagnostic and Statistical Manual of Mental Disorders (DSM)V, argues Harold J. Bursztajn, MD, associate clinical professor of psychiatry at Harvard Medical School in Cambridge and co-founder of the Program in Psychiatry and the Law at Beth Israel Deaconess Medical Center.
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In the eyes of cost-cutting hospital administrators, bioethics programs are sometimes perceived as a luxury rather than a necessity. During periods of austerity, bioethics programs are often the first to not receive funding or not be maintained, says Joseph J. Fins, MD, MACP, the E. William Davis, Jr. Professor of Medical Ethics and chief of the Division of Medical Ethics at Weill Cornell Medical College, and director of medical ethics and attending physician at New York Presbyterian Hospital-Weill Cornell Medical Center in New York City. A number of programs have recently come under threat.
