Tricks of the Trade
Related Articles
- CNS Drugs Have a Low Approval Rate. // Applied Clinical Trials;Apr2012, Vol. 21 Issue 4, p20
The article reports that only one out of 10 central nervous system (CNS) disease targeting drugs that underwent clinical testing between 2002 and 2007 were approved. It says that CNS drug manufacturers have more difficult obstacles that must be overcome to develop CNS chronic disease treatments...
- Novel methods to deal with publication biases: secondary analysis of antidepressant trials in the FDA trial registry database and related journal publications. Moreno, Santiago G.; Sutton, Alex J.; Turner, Erick H.; Abrams, Keith R.; Cooper, Nicola J.; Palmer, Tom M.; Ades, A. E. // BMJ: British Medical Journal (Overseas & Retired Doctors Edition;8/29/2009, Vol. 339 Issue 7719, p494
Objective To assess the performance of novel contour enhanced funnel plots and a regression based adjustment method to detect and adjust for publication biases. Design Secondary analysis of a published systematic literature review. Data sources Placebo controlled trials of antidepressants...
- FDA Warns of Suicidality Among Children Taking Antidepressants. // Journal of Psychosocial Nursing & Mental Health Services;Apr2004, Vol. 42 Issue 4, p8
The article focuses on a report by the U.S. Food and Drug Administration (FDA) regarding suicidal ideation and suicidal attempts of pediatric patients with major depressive disorder under clinical trials for various anti-depressant drugs. A preliminary review of reports for eight anti-depressant...
- Drugs on trial. Dunkin, Mary Anne // Arthritis Today;Sep/Oct92, Vol. 6 Issue 5, p28
Reports on the conduction of clinical trials to evaluate the effectivity of drugs for a certain disease. Phases of the clinical trial; Approval from the Food and Drug Administration; Approval of new uses of drugs for conditions besides the one for which the drug was first approved; Benefits and...
- The debate over placebo controls continues. // Drug Utilization Review;Feb2002, Vol. 18 Issue 2, p10
Debates on the use of placebo-controlled trials in the United States (U.S.). Circumstances where placebo-controlled trial may be ethically acceptable; How the U.S. Food and Drug Administration accepted the use of placebo-controlled trials when a proven policy exists; Purpose of placebo controls.
- BioCryst's Fodosine: Following The Lead Of Zolinza Approval? Osborne, Randall // BioWorld Financial Watch;4/2/2007, Vol. 15 Issue 14, p1
The article discusses the implications of new clinical trial regulations implemented by the U.S. Food and Drug Administration (FDA) for the development of intravenous Fodosine developed by BioCryst Pharmaceuticals Inc. The FDA has prohibited special protocol assessment (SPA) to randomized trials...
- Ventracor reports progress in two U.S. trials of VentrAssist. // Cardiovascular Device Update;Mar2007, Vol. 13 Issue 3, p12
The article reports on the progress of Ventracor in it its U.S. clinical trial programs, the Bridge to Transplant Trial and Destination Therapy Trial protocols, for its VentrAssist product. Food and Drugs Administration (FDA) has approved the clinical trials. The aim of the company is the...
- GTx's NDA for bone fracture drug accepted for review by FDA. // PharmaWatch: Biotechnology;Apr2009, Vol. 8 Issue 4, p13
The article reports on the announcement by GTx Inc. concerning the acceptance for review by the U.S. Food and Drug Administration its new drug application for bone fracture. It is noted that the new drug application is supported by results from a randomized phase III clinical trial of men with...
- Schizophrenia: The drug deadlock. Abbott, Alison // Nature;11/11/2010, Vol. 468 Issue 7321, p158
The article focuses on the clinical trials which compare the drugs for the treatment of schizophrenia. It says that the 43 million US dollars trial for testing an anti-psychotic drug introduced in 1990 revealed similar, such as perphenazine that leaves patients confused, socially withdrawn, and...
