• EMA: Public Input on Clinical Trials Transparency 'Unprecedented,' May Cause Delays

    If you had any doubt that clinical trial transparency is shaping up to be one of the hottest regulatory topics, look no further than the European Medicines Agency (EMA), which announced this week that it had received more than 1,000 comments on its draft transparency policy. Background In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, especially after some companies were found to have hidden unfavorable ...
  • GSK to Publish Results of All Clinical Trials Conducted since Company's Founding

    • 05 February 2013
    Pharmaceutical manufacturer GlaxoSmithKline is making waves for the second time in the last four months, announcing that in response to a new clinical trials data transparency initiative, it will commit to make all clinical study reports (CSRs) publicly available through its proprietary clinical trials register. Background GSK made a similar announcement in October 2012, when it said that it would soon publish clinical trials data using a secure database available to ...
  • Group Calls on Regulatory Agencies to Release Clinical Trials Data

    • 09 January 2013
    A new initiative started by a group of research groups, including the British Medical Journal (BMJ) , the Cochrane Library and host of other influential researchers, is calling on regulators to require that the results of all clinical trials information be published. The group, calling themselves "All Trials Registered, All Result Reported Initiative," notes in a statement that, "Thousands of clinical trials have not reported their results; some have not even been reg...