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While plagiarism of others’ work is universally condemned, authors’ reuse of their own words and data (so-called ‘self-plagiarism’) is a far more contentious issue. The recycling of one's own text, in particular, polarizes opinion: some consider it…
Access to patient data gathered in clinical trials is a highly controversial and complex issue that needs to balance three aspects: the public right to transparency regarding data used to approve new medicines, protection of the data privacy rights…
Sharing of deidentified/anonymised individual participant data is rapidly becoming the norm. The International Committee of Medical Journal Editors recently implemented requirements for data sharing as a condition for considering publication of…
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…
Analyses of integrated databases of efficacy and safety are a Food and Drug Administration (FDA) requirement. They are very useful in evaluating the safety and efficacy data gathered in multiple clinical studies. However, their utility is dependent…
There is no doubt that the public interest in healthcare-related issues is growing. This, coupled with the surge in the use of social media, leaves the pharmaceutical industry with a set of unique opportunities and challenges. The screening and…
We describe the development of a graphical abstract for lay summaries of clinical trial results. The new graphical summary serves the same purpose for a lay summary as an abstract does for a scientific publication. Lay summaries are intended to…
International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…
The demand for greater transparency in financial relationships between the healthcare industry and healthcare professionals is increasing globally, and has led to establishing government regulations and professional guidelines for detailed reporting…
A paradigm shift in clinical trial data reporting is occurring as data becomes increasingly publically accessible. The EMA was the first regulatory authority to publish clinical data included in marketing authorisation applications.
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