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While some of the pharmaceutical industry’s largest players are continuing to hide key information, companies are doing a better job making clinical trial data public, according to a recent study.
Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, wants the FDA to provide information for his ongoing investigation into alleged abuses of participants in clinical trials run by for-profit testing centers.
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.
Recent criticism from the medical journal community, which accused drugmakers of withholding information from online public trial registries, is unfounded and unfair, according to a pair of large pharmaceutical firms that said they are doing everything in their power to improve transparency and accessibility.
Clinical trial data submitted to online registries must contain useful and complete information for the study to be eligible for publication, according to the International Committee of Medical Journal Editors (ICMJE), which accused some manufacturers of providing incomplete data sets.
A large percentage of investigators conducting medical research have not had proper training and are rarely credentialed by an accreditation organization, according to clinical trials experts, many of whom are concerned about the quality of future clinical studies and the integrity of those who will oversee them.
Clinical trials professionals hope the FDA will have a new adverse event reporting system (AERS) in place before the end of next year to help streamline the reporting process, which has become increasingly onerous for researchers.
Aventis, part of the Sanofi-Aventis Group, has been awarded a multimillion-dollar contract by HHS to ensure enough chicken eggs are available to sustain year-round, full-capacity manufacturing of pandemic influenza vaccine.