Guidelines for disclosing the results from observational trials - Volume 26, Issue

Observational trials are a relevant part of clinical research. Publishing their results can be challenging for scientists and writers.  The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement was the first…

Statistical analyses and methods in the published literature: The SAMPL guidelines - Volume 25, Issue

Despite calls for guidelines on reporting statistical aspects of studies, most journals have still not included in their instructions for authors more than a paragraph or two about reporting statistical methods and results. However, given that many…

Post-approval regulatory writing – How different is it from writing pre-approval documents? - Volume 23, Issue

Regulatory writing has various facets to it with good writing skills as a preliminary requirement. Well written reports form the basis of all regulatory submissions for marketing approval and its success largely depends on the research information…

The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance - Volume 23, Issue

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…

2022 update to Good Publication Practice Guidelines for Company-Sponsored Biomedical Research - Volume 31, Issue

Regulatory Matters - Volume 28, Issue

November 30, 2018 – EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications for certain haemophilia medicines. The revised guideline for haemophilia medicines for factor VIII deficiency…

Ins and outs of environmental risk assessments (ERA) of medicinal products for human use - Volume 31, Issue

An environmental risk assessment (ERA) is the process of evaluating the effects of drugs for human use on the environment. ERAs must accompany all new drug market authorisations in Europe. In this article, we discuss the current guidelines on ERAs…

Manuscript Writing - Volume 21, Issue

Guidelines for manuscript writing: Here to help Although sometimes maligned, guidelines make manuscript writing easier and increase the chances of getting published. A good set of guidelines can be used as a checklist (many even include…

Regulatory Matters - Volume 30, Issue

One key point in 2012 to the Good Pharma - covigilance Practices (GVP) guidelines was mandatory consultation of all stakeholders before the first publication of GVP and after its implementation. Execution of these guidelines was influenced by public…

Potential implications of wider data transparency in medical communications - Volume 22, Issue

The current medical communication environment is characterised by growing calls for increased data transparency. There are ongoing concerns about the selective publication of trial results and the potential impact on use of medicines by prescribers…