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  • Regulatory NewsRegulatory News

    21st Century Cures Act Deadlines Approach in March and June

    The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March. Among those provisions of the law that must be acted upon within 90 days of the law’s enactment (or by 13 March) inc...
  • Regulatory NewsRegulatory News

    Final Rule on Clinical Trial Transparency: Will it be Enough to Encourage More Compliance?

    The National Institutes of Health (NIH) on Friday issued a final rule that its leaders said is expected to result in “rapid increases” in the percentage of trials registered and shared via  ClinicalTrials.gov , though it remains to be seen if the $10,000 per day penalties that can be assessed by the US Food and Drug Administration (FDA) will be strictly enforced. Writing in a JAMA Viewpoint on Friday, NIH Director Francis Collins and other senior leaders said: “Inves...
  • Regulatory NewsRegulatory News

    Proposed Rule Calls for Clinical Trial Results to be Reported, Even When Product Isn't Approved

    The US Department of Health and Human Services (DHHS) today unveiled new proposed requirements for its online clinical trials register, ClinicalTrials.gov, that will require pharmaceutical and medical device companies to submit more information regarding patient enrollment, the progress of trials and the results of those trials--even when a product is never approved in the US. Background Under section 801 of the Public Health Service Act (PHSA) , as amended by the Foo...
  • Regulatory NewsRegulatory News

    Legislators Want More Transparency About How Drugs Impact Women

    More than a month after pressing the US Food and Drug Administration (FDA) to do more to promote the participation of women and minorities in clinical trials, more than a dozen members of Congress are again pressing government officials to take action on the issue, this time focusing their efforts on clinical data transparency. Background In March 2014, a bipartisan group of female senators wrote to FDA , urging it to do more to ensure the equitable participation...
  • Study Finds Widespread Problems in Reporting of Clinical Trial Results

    According to a new study published in the Journal of the American Medical Association (JAMA) , the results of clinical trials reported to the public are frequently inaccurate, raising questions about the accuracy of current and future trial transparency efforts. The study, Reporting of Results in ClinicalTrials.gov and High-Impact Journals , looked at 96 different research trial results published in prestigious medical journals (impact factor greater than or equal to 1...
  • Legislation would Create New Incentives, Penalties to Compel Reporting of Trials Results

    • 10 June 2013
    A new piece of legislation introduced in the US House of Representatives last week would require clinical trials to report their results to an existing registry maintained by US officials or risk losing both current and future funding. Background At present, sponsors of clinical trials are responsible for making basic data available to the public through a database maintained by the US Food and Drug Administration ( FDA ) and the National Institutes of Health (NIH) know...
  • US Would See Clinical Trials Reporting Transparency Under New Legislation

    Massachusetts U.S. Rep. Ed Markey has announced the reintroduction of legislation that he says is intended to open up clinical trial data, introducing a measure of transparency and bringing the US closer toward reforms now underway in the EU. Background The bill, known as the Trial and Experimental Studies Transparency (TEST) Act , was first introduced in August 2012 by Markey and Rep. Elijah Cummings, a fellow member of the House Energy and Commerce Committee on which...
  • Health Canada to Open Clinical Trials Database

    As of April 2013, Health Canada intends to provide public access  to its own clinical trial database covering Phase I, II and III drug trials that have been authorized in Canada. The database is seen as an interim measure that will provide only basic information on each trial such as the protocol title, study population, and sponsor.  The establishment of a formal Canadian trial registry is being considered for implementation at a later date. Health Canada's ...
  • Clinical Trial Results to be made Public Under Proposed Legislation

    A new bill proposed in the US House of Representatives would require clinical trial sponsors to publish the results of any clinical trial-domestic or foreign-conducted in support of a product application before the US Food and Drug Administration (FDA). The bill, the Trial and Experimental Studies Transparency (TEST) Act of 2012 , was introduced by Rep. Ed Markey (D-MA), a member of the House Energy and Commerce Committee whose oversight duties include the healthcar...
  • Feature ArticlesFeature Articles

    ClinicalTrials.gov: Requirements and Implementation Strategies

    The Food and Drug Administration Amendments Act of 2007 ( FDAAA ) established a requirement for certain clinical trials to be registered at trial initiation and to report summary results after trial completion in the public registry and results database called ClinicalTrials.gov . This law is intended to facilitate enrollment in clinical trials, allow for tracking of the progress of such trials and address problems with the lack of timely dissemination of research fi...
  • Study: Many Clinical Trials Small, of Poor Quality

    Amidst an explosion in the number of clinical trials registered with US regulatory authorities, a new study analyzing clinical trials conducted in the US has found most of them to be relatively small and of inconsistent-and often poor-quality. The study, Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010 , was published in the Journal of the American Medical Association (JAMA) on 2 May 2012. "Clinical trials registered in ClinicalTrials.go...