FDA Safety and Innovation Act

Department of Internal Medicine, Yale School of Medicine, 333 Cedar St, I-456 SHM, PO Box 208008, New Haven, CT 06520, USA.
JAMA The Journal of the American Medical Association (Impact Factor: 35.29). 10/2012; 308(14):1437-8. DOI: 10.1001/jama.2012.12829
Source: PubMed
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    ABSTRACT: Rare diseases typically affect fewer than 200 000 patients annually, yet because thousands of rare diseases exist, the cumulative impact is millions of patients worldwide. Every form of childhood cancer qualifies as a rare disease-including the childhood muscle cancer, rhabdomyosarcoma (RMS). The next few years promise to be an exceptionally good era of opportunity for public-private collaboration for rare and childhood cancers. Not only do certain governmental regulation advantages exist, but these advantages are being made permanent with special incentives for pediatric orphan drug-product development. Coupled with a growing understanding of sarcoma tumor biology, synergy with pharmaceutical muscle disease drug-development programs, and emerging publically available preclinical and clinical tools, the outlook for academic-community-industry partnerships in RMS drug development looks promising.Oncogene advance online publication, 13 May 2013; doi:10.1038/onc.2013.129.
    No preview · Article · May 2013 · Oncogene
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    ABSTRACT: Complex, oncologic surgery is an important component of resident education. Our objective was to evaluate the impact of resident participation in oncologic procedures on overall 30-day morbidity and mortality. A retrospective cohort analysis was performed using the National Surgical Quality Improvement Program Participant User Files for 2005-2009. Colorectal, hepatopancreaticobiliary, and gastroesophageal oncology procedures were included. Multivariate logistic regression was used to assess the impact of trainee involvement on 30-day morbidity and mortality after adjusting for potential confounders. A total of 77,862 patients were included for analysis, 53,885 (69.2 %) involving surgical trainees and 23,977 (30.8 %) without trainees. The overall 30-day morbidity was significantly higher in the trainee group [27.2 vs. 21 %, adjusted odds ratio (AOR) 1.19, 95 % confidence interval (CI) 1.15-1.24, p < 0.0001)]; however, there was significantly lower 30-day postoperative mortality in the trainee group (1.9 vs. 2.1 %, AOR 0.87, 95 % CI 0.77-0.98, p = 0.02) and significantly lower failure-to-rescue rate (defined as mortality rate among patients suffering one or more postoperative complications) (5.9 vs. 7.6 %, AOR 0.79, 95 % CI 0.68-0.90, p = 0.001). The overall 30-day morbidity was highest in the PGY 5 level (29 %) compared to 24 % for PGY 1 or 2 and 23 % for PGY 3 (AOR per level increase 1.05, 95 % CI 1.03-1.07, p < 0.0001). Trainee participation in complex, oncologic surgery is associated with significantly higher rates of 30-day postoperative complications in NSQIP-participating hospitals; however, this effect is countered by overall lower 30-day mortality and improved rescue rate in preventing death among patients suffering complications.
    No preview · Article · Jul 2013 · Annals of Surgical Oncology

  • No preview · Article · Oct 2013 · JAMA The Journal of the American Medical Association
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