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Adolor’s stock took a major hit after the company and GlaxoSmithKline announced data showing that their new drug alvimopan, designed to treat opioid-induced bowel dysfunction (OBD), was ineffective in two of three clinical trials.
The FDA recently received comments on its “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials,” and experts are asking for specific examples of when to use Bayesian statistics.
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK equivalent of the FDA, has amended the country’s clinical trial regulations to bring them into compliance with the European Commission’s Good Clinical Practice (GCP) Directive (Directive 2005/28/EC1).
An experimental device appears to be effective in eliminating or reducing migraine headaches when administered during the onset of the migraine, according to a study conducted at the Ohio State University (OSU) Medical Center.
The FDA has placed a rare clinical hold on a trial sponsored by Corautus Genetics after the company reported three severe adverse events in a 10-day period.
A new Rhode Island company called Analytical Edge has announced a partnership with Brown University to develop and market a statistical methodology designed to reduce the length and cost of clinical trials by cutting the average number of participants required and allowing more flexible data analysis.
Altea Therapeutics announced May 25 it has begun Phase I clinical trials in the U.S. for AT3022, a fentanyl citrate transdermal patch to treat severe chronic pain.
Differences in the regulations for device trials as opposed to those for drugs can lead clinical sites into trouble if they do not understand those differences, said officials at a company currently conducting two Phase III investigational device exemption (IDE) trials.
An ambitious World Health Organization (WHO) plan to register every clinical trial conducted anywhere in the world could have a chilling effect on new drug development, according to PhRMA.