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Since its inception 20 years ago, the Medical Dictionary for Regulatory Activities (MedDRA) has become the lingua franca of safety reporting in a regulatory context. The standardised reporting across different regulatory regions and languages is a…
Health economic evaluations are relevant to those making healthcare resource allocation decisions, such as listing a new drug on the national formulary or launching a new vaccination programme. Compared with clinical studies that report only the…
If economic evaluations are to be used by researchers and healthcare decision makers, they need to be adequately reported. This article discusses the update of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022), the main…
Several initiatives have been taken to standardise the reporting of animal studies in peer-reviewed scientific journals, such as the ARRIVE (Animal Research: Reporting of In Vivo Experiments) and GSPC (Gold Standard Publication Checklist)…
The 2 year EMWA-AMWA CORE Reference project resulted in the publication of the open-access CORE Reference at http://www.core-reference.org on 03 May 2016. The full peer-reviewed publication supporting the launch of CORE Reference: Hamilton S,…
At present, there are no specific requirements for the reporting of preclinical research, and many studies, particularly those with negative results, never get published. Despite the huge advances in communication opportunities, things have not…
Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands,…
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…
Bioanalytical reports are usually written by bioanalysts. Medical writers offer a valuable contribution to bioanalytical reporting, increasing the efficiency of document development and improving the quality of data presentation. This article…
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…
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