• PCORI Board Adopts CER Standards

    The Board of Governors of the Patient-Centered Outcomes Research Institute (PCORI) at its 19 November 2012 meeting in Boston, MA adopted 47  revised methodology standards  that are intended to guide the comparative effectiveness research (CER) funded by PCORI.  The Board also authorized at the meeting the development of three new CER funding announcements: Treatment options for uterine fibroids, the safety and benefits of treatment options for severe asthm...
  • Animal Research Oversight in Need of Reform, Argues Researcher

    • 09 November 2012
    Are Institutional Animal Care and Use Committees (IACUCs)-groups used to ensure research conducted on animals meets basic ethical standards-meeting their ethical responsibilities and the original intent of Congress? Not even close, argues a researcher in the latest issue of the British Medical Journal . Writing in the 6 November 2012 issue of BMJ , Lawrence Arthur Hansen, a researcher at the University of California San Diego's Department of Neurosciences and Patho...
  • Researchers: Need for More Neonate-Specific Clinical Drug Research

    Researchers writing in the research publication Journal of Pediatrics (JP) are calling for the increased inclusion of neonates in pediatric drug trials, arguing that the sub-group is highly underrepresented, potentially to the detriment of newborn children. The article , scheduled to be published this week, takes note of an oft-discussed problem: Pharmaceutical products are rarely studied in children to the same extent as adults, resulting in many of those products be...
  • NIH to Publish Updated List of Priority Therapeutic Areas for Pediatric Research

    • 25 October 2012
    The National Institutes of Health (NIH) is preparing to release a new report detailing the therapeutic needs of pediatric patients under the Best Pharmaceuticals for Children Act (BPCA) , a piece of legislation aimed at promoting the safe prescribing of medicines for children. The 2002 law, similar to the Pediatric Research Equity Act (PREA) , allows FDA to work with sponsors of certain therapeutic products to conduct postmarketing studies involving children in ret...
  • NIH Clinical Research to Undergo 'Paradigm Shift' Under New Research Plan

    • 27 September 2012
    The National Institutes of Health (NIH) announced on 25 September the launch of a new clinical trials network it hopes will broaden the scope of research to include more real-world research settings while making it easier for patients to enroll in studies. The network, known as the Health Care Systems Research Collaboratory (HCSRC), will engage with existing healthcare systems such as health maintenance organizations to conduct, "Large-scale and more cost-effective cli...
  • Large Carriers Cave to Animal Rights Groups, Placing New Burdens on Preclinical Research

    • 21 September 2012
    Conducting preclinical research is likely to become even more difficult under new policies announced by major cargo carriers, reports Scientific American . FedEx and UPS, two of the world's largest shipment and logistics companies, have announced respective agreements with People for the Ethical Treatment of Animals (PETA) to prevent the shipment of mammals for use in preclinical testing. The move is likely to place additional burdens on clinical researchers, who r...
  • PCORI: Industry Likely Skewing Trial Outcomes to Detriment of Patients, Regulators

    • 26 July 2012
    It's an age-old question: Are life science companies influencing the outcomes of clinical trials? While it may not have a clear-cut answer, a newly-formed semi-governmental agency has announced it's looking to at least partially address it by focusing on how to make clinical trials more responsive to the needs of patients-a development with potentially huge implications for the pharmaceutical and medical device industries. The Patient-Centered Outcomes Research Institute...
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    Lister and Semmelweis - Two Misunderstood Geniuses

    • 17 July 2012
    In a recent The New England Journal of Medicine review of the past 200 years of surgery, author Atul Gawande, MD, MPH, mentioned that Joseph Lister's seminal work on antisepsis was regarded with overwhelming skepticism by the medical profession. 1 This was despite the fact Lister's work was heralded in a series of articles he wrote for The Lancet . However, this same journal found the alleged breakthrough as a method neither original nor beneficial. 2 Ignac Semmelw...
  • Pending Legislation Would Enhance Penalties for Theft, Falsification of Medical Products

    • 25 June 2012
    A piece of legislation scheduled to be voted on by the US House of Representatives this week would enhance fines and prison time for those found guilty of stealing medical products, including pharmaceuticals and medical devices. But the law contains a provision that could complicate efforts by third-party researchers to obtain and study counterfeit medicinal products for investigative purposes. The legislation, known as the Strengthening and Focusing Enforcement to Det...
  • Researchers: Have Clinical Trial Regulation Progressed too Quickly in Developing Nations?

    • 15 June 2012
    "Two steps forward, one step back," laments an old proverb, describing the all-too-common tendency of progress to come paired with unexpected setbacks. Take, for instance, clinical trials regulations in emerging countries, write two researchers in the 12 June issue of the open source medical journal The Public Library of Science: Medicine (PLoS:M) . Many of the countries once lacked any semblance of a regulatory system, leaving trials to exist in a regulatory vacuum-if ...
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    Pitfalls in Good Clinical Practice

    A pitfall can be defined as a potential and usually unanticipated disaster or difficulty. 1 When we perform clinical studies we try to anticipate unforeseen pitfalls before they arise. However, other occurrences are clearly foreseeable, yet we permit them-or cause them-to happen. Good Clinical Practice (GCP) refers to international standards of quality for the performance of clinical studies with human subjects. These standards aim to ensure the data generated are h...
  • NIH Drug Development Acceleration Program Expands to Include New Members

    A program launched by the National Institutes of Health (NIH) to repurpose existing advanced-stage drug compounds by partnering with pharmaceutical manufacturers has expanded to more than double its existing membership, the NIH announced on 12 June. The initiative, known as the Discovering New Therapeutic Uses for Existing Molecules program, was founded in May 2012 by the newly-formed National Center for Advancing Translational Sciences (NCATS) to take the existing com...