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.
- 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...
- Earlier drug tests on people could be unsafe, critics warn. Wadman, Meredith // Nature Medicine;Feb2006, Vol. 12 Issue 2, p153
The article reports that the U.S. Food and Drug Administration announced a significant loosening of the rules that govern experimental drugs to be tested in people. The new rules on drug development will allow scientist to test small doses of experimental drugs in people before full-scale...
- Dying to live. // Nature Medicine;Jun2006, Vol. 12 Issue 6, p593
The article reports that Abigail Alliance has filed a lawsuit against the U.S. Food and Drug Administration that challenges its policy of providing access to a new drug only after a series of clinical trials have proven its safety and efficacy. A U.S. Court of Appeals has sided with Abigail...
- Recruiting Healthy Volunteers for Research Participation via Internet Advertising. Bramstedt, Katrina A. // Clinical Medicine & Research;Jun2007, Vol. 5 Issue 2, p91
Objective: The Internet is frequently used as a tool to recruit research subjects, and the US Food and Drug Administration (FDA) provides general guidance regarding such advertising. The goal of this study was to explore the incidence and nature of ethically inappropriate recruiting...
