20 resultados para Safety data recording and reporting


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Our research described in this paper identifies a three part premise relating to the spyware paradigm. Firstly the data suggests spyware is proliferating at an exponential rate. Secondly ongoing research confirms that spyware produces many security risks – including that of privacy/confidentiality breaches via illicit data collection and reporting. Thirdly, anti-spyware controls are improving but are still considered problematic for several reasons. Our research then concludes that control measures to counter this very significant challenge should merit compliance auditing – and this auditing may effectively target the vital message passing performed by all illicit data collection spyware. Our research then evolves into an experiment involving the design and implementation of a software audit tool to conduct the desired compliance auditing. The software audit tool is positioned at the protected network’s gateway. The software audit tool uses ‘phone-home’ IP addresses as spyware signatures to detect the presence of the offending software. The audit tool also has the capability to differentiate legitimate message passing software from that produced by spyware – and ‘learn’ both new spyware signatures and new legitimate message passing profiles. The testing stage of the software has proven successful – albeit using very limited levels of network message passing variety and frequency.

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Objective: Five double-blind, randomized, saline-controlled trials (RCTs) were included in the United States marketing application for an intra-articular hyaluronan (IA-HA) product for the treatment of osteoarthritis (OA) of the knee. We report an integrated analysis of the primary Case Report Form (CRF) data from these trials. Method. Trials were similar in design, patient population and outcome measures - all included the Lequesne Algofunctional Index (LI), a validated composite index of pain and function, evaluating treatment over 3 months. Individual patient data were pooled; a repeated measures analysis of covariance was performed in the intent-to-treat (ITT) population. Analyses utilized both fixed and random effects models. Safety data from the five RCTs were summarized. Results: A total of 1155 patients with radiologically confirmed knee OA were enrolled: 619 received three or five IA-HA injections; 536 received. placebo saline injections. In the active and control groups, mean ages were 61.8 and 61.4 years; 62.4% and 58.8% were women; baseline total Lequesne scores 11.03 and 11.30, respectively. Integrated analysis of the pooled data set found a statistically significant reduction (P < 0.001) in total Lequesne score with hyaluronan (HA) (-2.68) vs placebo (-2.00); estimated difference -0.68 (95% CI: -0.56 to -0.79), effect size 0.20. Additional modeling approaches confirmed robustness of the analyses. Conclusions: This integrated analysis demonstrates that multiple design factors influence the results of RCTs assessing efficacy of intra-articular (IA) therapies, and that integrated analyses based on primary data differ from meta-analyses using transformed data. (C) 2006 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved.