Journal Watch
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Journal Watch
Ó Springer International Publishing Switzerland 2014
Pharmaceutical medicine is an evolving discipline and research and development activity within the field is high. This section of the journal is intended to help you keep up to date with the latest advances worldwide in various aspects of pharmaceutical medicine. Each issue includes a selection of articles published in recent issues of other Adis publications. Full-text versions of these papers are available at http://link.springer.com.
1 Converting to a Common Data Model: What is Lost in Translation? Observational drug safety and effectiveness studies provide important evidence for clinical practice. However, metaanalysis of these studies requires extensive efforts and quality control. Although observational studies at first glance may seem to address the same underlying question, differences in study design, definitions, and settings often limit our ability to compare and synthesize. Study designs may vary, sometimes with clear differences, but often with subtle nuances. Different observational data sets may have different biases. Data collected in routine care often reflect different healthcare delivery systems. As a result, an individual researcher trying to synthesize available evidence truly faces a challenge. In an ideal world, a more harmonized method would be available by which data and results from different databases could be combined to answer a specific question. An overarching, generic protocol should drive pooling of results from multiple healthcare databases. Standard extraction and transformation tools together with common analytical tools should be part and parcel of each study. All these steps should be fully transparent, fast and reproducible.
Rijnbeek PR. Converting to a common data model: what is lost in translation? Drug Saf 2014; 37 (11): 893–6.
2 Should Off-Label Drugs Be Included as Comparators in Pharmacoeconomic Studies? In the USA, the Food and Drug Administration (FDA) approves a drug for marketing for a particular indication. However, prescribers are allowed to use drugs ‘off-label’ (i.e. for an unapproved use) at their discretion. In the treatment of cancer, for example, off-label uses are very common. Outside of cancer care, substantial amounts of off-label drug use have been observed, often with little existing evidence. In addition, there has been a substantial increase in the offlabel uses of antipsychotics. New drugs used off-label have the potential to increase prescribing costs dramatically without any information regarding patient outcomes. On the other hand, off-label uses can become a standard of care and may even reduce costs if they are effective. For example, Avastin (bevacizumab) does not have a labelled indication for age-related macular degeneration but has been receiving attention in Europe, where cost savings have been cited as a reason for approving payment coverage for those patients. A key challenge for stakeholders, including both Medicare and Medicaid in the USA, is distinguishing off
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