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Nearly every hospital has them, and most doctors have seen them, treated them, and agonized over them. They are patients with a slim, if not nonexistent, chance of recovery, who continue to receive intense, invasive, and costly procedures because there is no other clear alternative.
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The Department of Veterans Affairs (VA) last month issued a nationwide ultimatum to its medical centers involved in research to shape up or else.
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The Baylor College of Medicine in Houston has a prescribed inquiry process for complaints generated by human subject research at the institution, says Kathleen Motil, PhD, MD, associate professor of pediatrics and chair of two of the colleges IRBs.
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Two years ago, Baylor College of Medicine had a dilemma: double its staff to accommodate the increase in study protocols being submitted to its IRB or find an electronic solution to its problem. They chose the latter.
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While the Health Insurance Portability and Accountability Act of 1996 (HIPAA) is clearly getting all the headlines and a great deal of attention in the research community, the recent Food and Drug Administration (FDA) Guidance for Industry on Electronic Records indicates it is not the only game in town.
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As genetics research yields more and more information about individuals predispositions to disease and illness, researchers are beginning to question whether study participants should have access to the genetic information obtained about them.
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Postmenopausal estrogen-progestin therapy increased the risk of breast cancer in a population-based cohort in Sweden, and estrogen-only did not.
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In a multicenter, Italian, randomized, phase III trial, single-agent vinorelbine or gemcitabine proved to be as effective as a combination of the 2 agents in the treatment of advanced non-small-cell lung cancer occurring in patients 70 years and older.
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Women older than age 70 comprise 15-20% of breast cancer patients. Some of these older patients may not be able to tolerate or do not desire the standard surgical procedures of either lumpectomy or mastectomy.