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Last updated on April 20, 2014 at 14:04 EDT

Latest ClinicalTrials.gov Stories

2014-04-01 14:31:40

OHSU analysis in Annals of Internal Medicine finds journals reported adverse events less frequently Medical researchers often presented the findings of their clinical trials in a different way on a federal government website than they did in the medical journals where their studies were ultimately published, according to an Oregon Health & Science University analysis published April 1 in the Annals of Internal Medicine. Researchers' reports in peer-reviewed medical journals often...

2014-03-05 14:41:49

An analysis of nearly 24,000 active human research clinical trials found that between 5 percent and 16 percent fall into a regulatory gap and are not covered by two major federal regulations, according to a study in the March 5 issue of JAMA. These trials studied interventions other than drugs or devices (e.g., behavioral, surgical). The primary federal human subjects protections (HSP) policies in the United States, including requirements for institutional review board review and informed...

2013-12-10 08:31:19

Impact of Delayed-Dose Administration Results also Announced at the American Epilepsy Society Annual Meeting MAPLE GROVE, Minn., Dec. 10, 2013 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (Upsher-Smith), today announced the presentation of new Phase 1 data showing that USL255 (extended-release topiramate) may provide a beneficial treatment option for individuals with difficulty swallowing whole capsules or tablets. Additionally, simulations of data from another Phase 1 study...

2013-12-04 10:41:23

Half of trials with results posted in ClinicalTrials.gov database have not been published in a journal, and for some that have, the database contains more information The trial registry ClinicalTrials.gov, which permits posting of trial results, includes results of some trials that have not been published in a peer-reviewed journal and in some cases includes more information than published trials, according to Carolina Riveros (INSERM, Paris, France) and colleagues, authors of a PLOS...

2013-11-06 20:22:18

Making it easier to find and contact clinical investigators for studies based on experience in disease indications. BOSTON, Nov. 6, 2013 /PRNewswire-iReach/ -- karmadata (www.karmadata.com) today announced the launch of its App Gallery, a revolutionary new technology platform for publishing healthcare data applications targeting user populations with very precise needs. Today also marks the official release of Indicate Investigators, the first App published in the gallery and built...

2013-10-30 14:02:48

Non-publication is more common among industry-funded trials, study finds A new analysis of 585 large, randomized clinical trials registered with ClinicalTrials.gov finds that 29 percent have not been published in scientific journals. In addition, nearly 78 percent of the unpublished trials had no results available on the website, either. As a result, nearly 300,000 people who were enrolled in the 171 unpublished trials "were exposed to the risks of trial participation without the...

2013-10-30 11:10:47

Study finds almost 1 in 3 large clinical trials still not published 5 years after completion Almost one in three (29%) large clinical trials remain unpublished five years after completion. And of these, 78% have no results publicly available, finds a study published on bmj.com today. This means that an estimated 250,000 people have been exposed to the risks of trial participation without the societal benefits that accompany the dissemination of their results, say the authors. They...

2013-10-22 11:00:30

A new report by researchers from Harvard University and others in a working group convened by the Multi-Regional Clinical Trials Center (MRCT) at Harvard proposes recommendations for addressing a problem that has vexed drug regulators: how to expand public access to data from clinical trials while protecting patients' privacy and weighing pharmaceutical companies' business interests. Recently, the European Medicines Agency (EMA) announced it will provide public access to participant-level...

2013-09-25 08:30:50

Virtify® CTRR Integrates with OnCore® Enterprise Research System LEXINGTON, Mass. and MADISON, Wis., Sept. 25, 2013 /PRNewswire/ -- Virtify, Inc., a leading innovator in content and regulatory information solutions for the life sciences industry, and Forte Research Systems, Inc., a leading developer of specialized clinical trial management software, announced today the integration of Forte Research Systems' OnCore® Enterprise Research system with Virtify CTRR® (Clinical Trial...

2013-09-24 12:28:16

FDA allows novel approach to study children with inborn errors of energy metabolism MOUNTAIN VIEW, Calif., Sept. 24, 2013 /PRNewswire/ -- Edison Pharmaceuticals announced today initiation of a phase 2 clinical trial titled "Therapeutic Trial of EPI-743 in Patients with Disorders of Energy Utilization or Oxidation-Reduction." The trial is a double-blind, placebo-controlled crossover study in which subjects will receive either EPI-743 treatment or placebo for six months. They will...