Patient registries

Cystic Fibrosis Foundation. CFF Patient Registry. Patient Registry Annual Data Report 2007. Bethesda, Maryland (2009). 

Current patient registries of children whose mothers took fluoxetine during pregnancy do not show adverse consequences... 

Cystic Fibrosis Foundation Patient Registry 2000. Annual Report. Bethesda, MD, Cystic Fibrosis Foundation, 2001. 

Cystic Fibrosis Foundation. Patient registry 1999. Annual data report. Bethesda, Md, September 2000. 

Post-marketing safety studies are considered in their own chapter of this book. However, it should be noted here that patient registries have been associated with grave jeopardy of litigation in the United States, and not necessarily on a sound scientific basis. On more than one occasion, pharmaceutical companies have been deterred from marketing new drugs when FDA has required a patient registry as a condition of NDA approval. 

Lai H, Kosorok MR, Sondel SA, et al. Growth status in children with cystic fibrosis based on the national Cystic Fibrosis Patient Registry data Evaluation of various criteria used to identify malnutrition. J Pediatr 1998 132 478 85. 

The most comprehensive and thorough analysis of the clinical outcomes of patients receiving home PN or EN comes from Medicare and the North American Home Parenteral and Enteral Patient Registry. It was estimated that 40,000 and 152,000 patients in the United States were receiving home PN and EN support, respectively. Patients with GI faUme, which included those with Crohn s disease, ischemic bowel disease, motility disorders, and congenital bowel defects had relatively good outcomes, especially when compared with the groups with cancer or AIDS. The patients with GI failme had an 87% annual survival rate and a 50% to 75% likelihood of complete rehabilitation. Sepsis, metabolic disorders, and mechanical problems with catheters resulted in one to two hospitalizations per year for aU patients. ... 

Human Gene Therapy, Human Gene Transfer/ Therapy Patient Registry-Summary, Human Gene Therapy 3 457,1992. 

DePestel DD, Hershberger E, Lamp KC, Malani PN. Safety and clinical outcomes among older adults receiving daptomycin therapy. Insights from a patient registry. Am J Geriatr Pharmacother 2010 8(6) 551-61. 

Nervous system The effect of antiplatelet drugs on the risk of subarachnoid hemorrhage has not been accurately quantified. In a population-based case-control study using data from the Danish National Patient Registry, 1186 patients with a first episode of subarachnoid hemorrhage were... 

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