Group-randomized trials in which participants are assigned to study arms in predetermined groups, instead of individually, infrequently met the unique statistical and design challenges required for this approach. These cancer trials may present misleading findings as a result.
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Biotechnology companies are increasingly turning to developing nations as sites for clinical trials, reports Genetic Engineering and Biotechnology News (GEN). Increasing competition for clinical trial patients in the industrialized world is one of the major reasons for the offshore move, according to an article in the March 15 issue of GEN
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FoxNews reports that within the next 18 months, medical researchers at The Seattle Biomedical Research Institute will be asking people in Seattle to volunteer to be exposed to the deadliest form of malaria to help them test the effectiveness of vaccine candidates.
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Researchers now have a possible solution for the one in three adults who fail to take their medicines as prescribed by their doctors, as well as for everyone else who occasionally forgets: a sensor necklace that records the exact time and date when specially-designed pills are swallowed, and reminds the user if any doses are being missed.
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Can a patient who agrees to participate in a safety study of a gene therapy protocol give truly informed consent and understand the risks involved when the consent forms are highly technical and the physician or institution seeking their consent has a stake in the study and its outcome?
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New ways to make sure people are adequately informed about the risks and benefits of taking part in a clinical trial can be field-tested for effectiveness as vigorously as new medical treatments themselves, a study led by a Johns Hopkins bioethicist suggests.
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Described as a hotspot of botanical diversity, there are more than 20,000 indigenous plant species in South Africa. Several thousand of them are used by traditional healers every day in that country for treating a range of problems from the common cold to serious diseases such as AIDS.
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Each year, pharmaceutical companies invest millions of dollars to test drugs, many of which will never reach the market because of side effects found only during human clinical trials. At the same time, the number of patients waiting for organ transplants continues to increase.
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Human Genome Sciences, Inc. (NASDAQ: HGSI) today announced the final results of a Phase 2b clinical trial of the investigational drug, Albuferon® (albinterferon alfa-2b), in combination with ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C.
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Shire plc, the global specialty biopharmaceutical company, today announced the results of a study which demonstrated that adults with Attention Deficit Hyperactivity Disorder (ADHD) experienced significant improvements in ADHD symptom control within one week of treatment with once-daily VYVANSE™ (lisdexamfetamine dimesylate), the first prodrug stimulant.
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Data from two Phase III clinical trials were presented today in Chicago at CHEST 2007, the annual scientific assembly of the American College of Chest Physicians (ACCP), supporting the use of Perforomist™ (formoterol fumarate) Inhalation Solution as a safe and effective maintenance treatment for COPD patients. The results of both studies were included as part of the New Drug Application (NDA) filing to the U.S. Food and Drug Administration (FDA) for Perforomist™ Inhalation Solution.
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Late-breaking data presented at TCT 2007, the scientific symposium of the Cardiovascular Research Foundation (CRF), show that the use of the anticoagulant bivalirudin following angioplasty in heart attack patients reduces net adverse clinical events by 24 percent compared to the standard treatment, and significantly reduces major bleeding that occurs after angioplasty by 40 percent.
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