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The phenomenon of missing data is ubiquitous in clinical studies. Both the extent of missing data and the structure of missing data can introduce bias into study results and lead to wrong conclusions. Medical writers should be aware of the extent of…
The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports…
The clinical research landscape is gradually changing as we enter the era of big data. Big data sources are multiplying as existing sources collide to create expanded platforms that serve wider areas of expertise. Clinical study designs…
Medical device manufacturers must continuously evaluate all clinical data available for their products marketed in Europe. With the European Medical Device Regulation 2017/745 coming into force in May 2021, manufacturers are required to assess…
The sharing of individual participant-level clinical data is now an almost routine extension of the clinical study life-cycle, and increasingly a vital element of leveraging real-word data. Responsible clinical study data sharing of appropriately…
A free and open-source software tool is presented that facilitates the analysis and the visualisation of data in basic life science. Daniel's XL Toolbox is an add-in for the Microsoft Excel® spreadsheet software. It enables scientists to store…
Bad Pharma provides a hyper-critical account of the pharmaceutical industry's approach to conducting, publishing and using clinical research and development. However, its attack on the drug regulators is unfair and its examination of the medical…
The first part of this article compares the main features of studies based on patient registry data with those of randomised clinical trials, providing a basis for better understanding the differences between the two. The second part details how to…
Unlike new drug development where superiority over an active comparator or placebo often has to be proven, biosimilar development focuses on showing similarity of the proposed biosimilar to an already approved reference product. This affects…
Critical thinking is necessary to edit a scientific article. However, in addition to questions about the language, we can also question the assumptions, documentation, and implications of the research, in a process I call “analytical editing.” A…
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