Journal Watch - Volume 21, Issue

Impact of protocol amendments, bias and quality in industry-funded trials, and rethinking authorship criteria Amendments to clinical trial protocols are widespread, but can result in increased costs and delays in study implementation.

Profile - Volume 26, Issue

The new European medical device regulation and guidance document on clinical evaluation An Interview with Dr Bassil Akra The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives…

Trial Trivia - Volume 32, Issue

We all know there is nothing trivial about clinical trials. But let’s have some light fun and the try answering the short quiz about the topic.

Medical Writing. 2023;32(1)53, 65

The Crofter: Sustainable Communications - Volume 32, Issue

EditorialSection Editor: Kimi Uegaki Growing and nurturing a grassroots sustainability team in a clinical centre Authors: Sarah Kabani, Virginie Chasseigne, Sihame Chkair Medical Writing. 2023;32(4):87–89. https://doi.org/10.56012/wynp1520

History of biostatistics - Volume 25, Issue

The history of biostatistics could be viewed as an ongoing dialectic between continuity and change. Although statistical methods are used in current clinical studies, there is still ambivalence towards its application when medical practitioners…

Regulatory Public Disclosure - Volume 31, Issue

A great deal has happened in the world of regulatory public disclosure in Europe in 2022 with the EU Clinical Trials Regulation (CTR) 536/2014 coming into force at the end of January 2022. We collectively attempt to assimilate knowledge and…

Science for all: Is it all about the publication of data, or beyond? - Volume 31, Issue

This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…

A primer on anonymisation - Volume 28, Issue

Canadian and European regulators finalised guidelines that allow for sharing of clinical trial data. To maintain the utility of clinical information, risk-based anonymisation techniques are recommended. It behoves applicants to ensure organisational…

In the Bookstores - Volume 22, Issue

Bad Pharma is the latest book by the well-known anti-quackery campaigner Ben Goldacre, and attempts to explain to us that medicine is broken. Despite the title, he criticises not only the pharmaceutical industry, but also regulators, doctors,…

Regulatory Matters - Volume 25, Issue

The growing need for drug safety documents When I first started in regulatory writing (over a decade ago now, how time flies when you’re a medical writer), the types of document that I would be involved in were typically clinical study reports,…