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The number of circulating tumor cells before treatment is an independent predictor of progression-free survival and overall survival in patients with metastatic breast cancer.
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Standard treatment for recurrent, diffuse non-Hodgkins lymphoma remains to be established, but several studies have indicated that autologous stem cell transplant has resulted in improved survival. For those with bulky recurrence, pre-transplant, second-line chemotherapy is recommended. In this setting, an optimal regimen would not commonly produce severe marrow toxicity as mobilization of stem cells will be required for optimal reconstitution after transplant.
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Clinical trial managers and investigators may need to brush up on the regulations regarding investigational device exemption (IDE) since researchers and research staff often forget about the three major categories of compliance regulations, an expert advises.
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As each clinical trials administrator knows, its difficult to predict every problem and extra cost that might occur during a lengthy trial process. But with experience and following best practice guidelines, an administrator may find that all goes as well as planned. He offers these suggestions for how to improve the clinical trials process and promote best practices in managing trials.
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The NIH roadmap calls for research collaborations that would harness technologies into a virtual research enterprise, which is one of the first areas in which the collaboration called Health Sciences South Carolina is focusing.
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Over the last decades, as awareness has grown that medical-related research and development leads to curing our diseases, mitigating our pain, and even giving us many more years of quality life, increasingly enormous amounts of money were and are being poured in the R&D coffers, says Nancy M. Deeg, co-founder/partner of Norfolk, VA-based Life Science Recruiters LLC.
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The way case report forms are handled can slow or expedite a clinical trials process, which ultimately will impact efficiency, workflow, and costs.
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Many clinical trials offices struggle with determining an accurate estimate of costs for research services, sometimes falling short of comfortable margin. In an effort to improve this process, a Detroit clinical trials office has developed complexity criteria and productivity standards.
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When NIH announced in late 2003 that it was rolling out the NIH Roadmap for Medical Research, there were no specific examples to show how this ambitious initiative might work in the real world.
