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Eli Lilly has formally adopted clinical trial registration standards proposed by the World Health Organization (WHO) — a commitment that comes roughly one year after the company became the first major drugmaker to launch an online trial registry.
Phase I cancer drug trials conducted to determine the safety and maximum dosage of a new agent are underreported in peer-reviewed journals — a trend that may delay scientific advances and harm patient care — say researchers at The University of Texas M. D. Anderson Cancer Center (ACC) in a new study recently published in the journal Cancer.
Drugmakers are still falling short of federal requirements to post certain clinical trial data to a government database, but compliance has been improving during the past three years, according to an FDA analysis of ClinicalTrials.gov, the NIH-sponsored repository where drugmakers are supposed to file their research data.
Traditional drug development models no longer are effective for today's pharmaceutical firms, according to an FDA report that identifies opportunities for improving the R&D process, including through greater sharing of "precompetitive" data and earlier testing of drug candidates in humans.
Pharmaceutical companies are still falling short of federal requirements to post certain clinical trial data to a government database, but compliance has been improving during the past three years, according to an FDA analysis of ClinicalTrials.gov, the NIH-sponsored repository where drugmakers are supposed to file their research data.
Effectively spreading the word about clinical trial results could improve awareness and support for new drugs, but many firms are not making the best communication decisions, according to a new study that recommends improvements.
The SEC has launched an investigation into allegations that Wall Street investors routinely pay medical researchers for confidential information about ongoing drug studies, according to The Seattle Times.
While most clinical trial sponsors continue to use paper data collection methods, more sponsors are using technology in their studies and recognize the need for electronic standards, according to a recent survey that included drugmakers and investigative sites.
Biogen Idec and Elan said they may restart clinical trials on their multiple sclerosis (MS) drug Tysabri after a patient safety screening revealed no new cases of a deadly brain disease that had been linked to the once promising product.
Cephalon’s narcolepsy drug Provigil has shown to improve wakefulness, performance and attention level in patients with shift work sleep disorder (SWSD), according to a Phase III trial report published in the Aug. 4 edition of The New England Journal of Medicine.