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27 Aug 2015, 12:51 pm by Schachtman
Thomas Fleming, a statistician and “trialist,” who had served on the data safety and monitoring board of the clinical trial at issue.[2] Fleming took the rather extreme view that a clinical trial that “fails” to meet its primary pre-stated end point at the conventional p-value of less than 5 percent is an abject failure and provides no demonstration of any claim of efficacy. [read post]
27 Jun 2014, 3:16 pm by Cicely Wilson
A transcoder translates the signals received by an antenna into data that can be transmitted over the Internet. [read post]
4 Jul 2013, 5:00 am by Bexis
Cornerstone Therapeutics, Inc., 2013 WL 3198153 (2d Cir. [read post]
 Akebia and Otsuka (together “Akebia”) also have a HIF-PH inhibitor, vadadustat, which is in clinical trials for the treatment of CKD anaemia. [read post]
4 Nov 2013, 9:56 pm by Jon Gelman
For example, when a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleges that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events. [read post]
1 Mar 2023, 9:29 am by Christine Clements and John Tilton
Lahey Clinic Hosp., Inc., 399 F.3d 1, 18 n.19 (1st Cir. 2005) (noting that “sampling of similar claims and extrapolation from the sample is a recognized method of proof” for the United States in an affirmative case seeking recovery under a common-law theory). [read post]
2 Jun 2021, 2:55 pm by Lawrence B. Ebert
Some background: The asserted patents arise out of research conducted by inventors at a company called QuantaLife, Inc. [read post]
12 May 2020, 2:22 am by David Jensen
  CIRM supported our early preclinical data all the way through our late stage clinical trials. [read post]
15 May 2019, 9:05 pm by Dan Flynn
The decade data review, which the authors expect will be a “reference baseline” for future years, was published by Mary Ann Liebert Inc. in an Open Access article, which permits unrestricted year. [read post]