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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…
Meta-analysis is a statistical technique for summarising the results of multiple studies in a quantitative manner. It should not be confused with a systematic review, though in practice the two are often found together. The main pitfalls with…
The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of…
Estimands represent a new way to look at key aspects of clinical research and will become increasingly important for medical writers. Estimands are detailed definitions of quantities to be estimated using clinical trial data, which make allowance…
According to the final rule on “Clinical Trials Registration and Results Information Submission”, clinical trial protocols and statistical analysis plans have to be published on ClinicalTrials.gov. The requirement affects all applicable clinical…
Observational studies pose a number of biostatistical challenges. Methodological approaches have grown exponentially, but most are rarely applied in the real world. The STRengthening Analytical Thinking for Observational Studies (STRATOS) initiative…
Retraction of research articles ruins careers, dents confidence in the scientific literature, and can have a profound impact on meta-analyses. Retraction rates have seen a big recent rise, as journals act increasingly quickly to remove articles that…
The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure ofclinical trials in…
Participation in meetings and events by healthcare professionals is part of their continuing professional development, and it is a requirement for organisers to gain accreditation for continuing professional development in order to attract…
For science to be understood, assimilated, and further developed, it must be accessible through clear and concise writing. Science is about solving problems that often interlink with each other. To improve the clarity of scientific writing, every…
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