Study Conduct

Re-accredited Russian investigative sites jump to almost 600 under new regulations’ Sept. 1 deadline

Monday, September 19, 2011 08:00 AM

The number of investigative sites that have been re-accredited by the Russian Ministry of Health (MoH)—a requirement inherent in the country’s new regulations—is now up to almost 600, according to the Association of Clinical Trials Organizations (ACTO), a trade group for those working in research in Russia.

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Study: 60% of protocols amended during clinical trials

Wednesday, September 14, 2011 10:41 AM

Nearly 60% of all protocols used in clinical trials for new drugs are amended during the study, but one-third of those changes could have been avoided, according to a new study, reported by PharmaTimes.

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Canadian government launches massive overhaul of clinical research process to create infrastructure

Monday, September 12, 2011 08:00 AM

The Canadian Institutes of Health Research (CIHR)—the federal government’s health research investment agency—is undertaking a massive overhaul of how clinical research is conducted, attempting to align large sites and other parties in all provinces to create an integrated research infrastructure.

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Aridhia partners with Glencoe Software

Tuesday, September 6, 2011 02:35 PM

Aridhia Informatics, a healthcare informatics company based in Glasgow, Scotland, has formed a strategic partnership with US company Glencoe Software to create support tools for the development of personalized medicine using real-world clinical, genetic and research data, according to PharmaTimes.

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Mayo Clinic sees potential of social media in patient recruitment

Thursday, September 1, 2011 12:32 PM

Social media and online networks could be of particular value in initiating, and recruiting patients for, studies of sometimes neglected rare medical conditions, US-based non-profit Mayo Clinic has found, according to PharmaTimes.

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Study: Cancer patients rarely participate in trials

Friday, August 26, 2011 01:14 PM

Very few patients who've had cancer surgery end up participating in clinical trials to test new treatments, researchers have found, according to Reuters.

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Physicians wary of using biosimilars

Wednesday, August 24, 2011 01:58 PM

Decision Resources finds that the majority of U.S. and European physicians are wary of using a biosimilar for an indication for which supporting clinical data are lacking. According to new analysis, physician attitudes about indication extrapolation-where a biosimilar needs only to show similarity in a phase III study for one indication, and it will be granted approval for other indications for which the branded product is used-vary by country. French physicians are the most conservative when asked about indication extrapolation when compared to German and U.S. physicians.

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Baby research results potentially unreliable

Wednesday, August 24, 2011 12:35 PM

Tests of medical treatments in babies vary markedly in quality, at least as judged by the reports that make it into scientific journals, researchers say, according to Reuters.

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Greenphire, Mytrus partner to enhance study efficiency

Wednesday, August 24, 2011 12:12 PM

Greenphire, based in suburban Philadelphia, and San Francisco startup Mytrus have developed web-based solutions to streamline the arduous tasks of recruiting, retaining, and efficiently administering clinical trials.  Greenphire’s ClinCard System, a web-based patient payment, management, and communication platform, compliments the functionality offered by Mytrus and its innovative methods for allowing patients to participate in clinical research studies directly from their own homes.

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DIA issues guide to improve computerized clinical trial data

Wednesday, August 17, 2011 10:36 AM

The rapid uptake and incorporation of computerized systems and electronic data management into clinical research needs to be backed up by sound validation processes to ensure data quality and integrity are not compromised, says the Drug Information Association (DIA), according to PharmaTimes.

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