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Post-authorisation safety studies (PASS), whether interventional or, more commonly, non-interventional (NI), can be used by entities such as the European Medicine Agency´s Pharmacovigilance and Risk Assess ment Committee to oblige drug companies to…
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…
Race and ethnicity are not clearly defined in biomedical literature and misaligned with genomics and epigenomic findings; the guidelines for consistent reporting in publications and regulations from health authorities are lacking. Minority…
Current clinical trial disclosure landscape in China Author and Section Editor: Zuo Yen Lee Section Editor: Clare Chang In China, before the launch of the current national clinical trial registry in 2013, i.e., ChinaDrugTrials.org.cn…
Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their…
Patient-reported outcomes (PROs) are an essential element to demonstrate the value of a health intervention. In many ways, PROs represent the ultimate “real-world” data, yet the drive towards “Big Data” has focused onroutinely collected data from…
I know all the stereotypes about vets. We work as clinicians as seen in All Creatures Great and Small and are intrinsically motivated to help every animal we cross. And yes, that is partly true. There are three major pillars in which vets can work.…
Stem cell technology holds a key, although arguably not an exclusive position, in the future of healthcare. Alongside two other candidates worthy of this mantle – personalized cancer medicine and vaccine development – all three healthcare…
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…
Randomised controlled trials (RCTs) have always been recognised as the highest level of evidence in medical research. However, they cannot address the questions that one comes across in real-world clinical practice. Observational studies can answer…
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