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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…
Community pharmacy has been recently criticised for selling products which do not have a rational or robust evidence base. Available evidence suggests that pharmacists understand and are willing to embrace the concepts of evidence-based medicine…
As health authorities aim to increase clinical trial transparency and visibility to the public, pharmaceutical manufacturers are facing new pressure points. New regulations require the disclosure of clinical trial application data, many of which cont…
Preclinical studies –is animal testing necessary?The drug regulatory authorities require testing in animals, to be exact in at least two mammalian species, before the first-in-human trials can be approved. Common criticism is that the results from…
The discussion section of a clinical study report The discussion section of a clinical study report (CSR) is often a source of doubt among medical writers. The advice is usually to keep the discussion section as short as possible and not go…
The Russian clinical trial industry and Russia’s local regulatory requirements are developing rapidly. Within Russian contract research organisations, medical writers must take on non-traditional roles and, in particular, must collaborate closely…
When medical writers discuss authors and authorship – the theme of this issue of medical writing – they are usually referring to documents in the public domain such as journal articles or maybe congress abstracts. The primary purpose of such…
Clinical trial data are rightfully protected by robust regulations; given these requirements and increasing demands from clients, a validated and compliant electronic document management system is now a necessity for established medical writing…
Altmetrics and other article-level metrics offer new opportunities to understand the impact of medical publications and, indeed, clinical trial programmes. For example, we can learn whether the publication has been viewed, shared, engaged with, or…
Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…
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