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The perils of the unknown: Missing data in clinical studies - Volume 27, Issue

The phenomenon of missing data is ubiquitous in clinical studies. Both the extent of missing data and the structure of missing data can introduce bias into study results and lead to wrong conclusions. Medical writers should be aware of the extent of…

Preparing clinical study reports for external sharing - Volume 27, Issue

As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have…

Promoting equity in understanding: A cross-organisational plain language glossary for clinical research - Volume 29, Issue

Clear communication with the public and with potential clinical trial participants and their caregivers is foundational to the ethical tenets of respect, justice, and beneficence. However, health literacy, even of highly educated individuals, often…

Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR - Volume 29, Issue

The new European Database on Medical Devices (Eudamed) is the platform to be used for the prospective registration of clinical investigations for medical devices under the Medical Device Regulations. However, Eudamed’s launch has been delayed till…

Biostatistics and medical writing: Synergy in preparing clinical trials documents - Volume 25, Issue

Biostatisticians and medical writers are among the key people who develop important documents for clinical trials. These documents include clinical study protocols, statistical analysis plans, statistical outputs, and clinical study reports. This…

Publication of clinical trial protocols and statistical analysis plans on ClinicalTrials.gov - Volume 28, Issue

According to the final rule on “Clinical Trials Registration and Results Information Submission”, clinical trial protocols and statistical analysis plans have to be published on ClinicalTrials.gov. The requirement affects all applicable clinical…

Carbon footprint of clinical trials: a high-level literature review - Volume 31, Issue

Thousands of clinical trials are conducted globally each year. Yet, little is known about their environmental impact. This paper presents the results of a high-level literature review of the carbon footprint of clinical trials. Five papers were…

Lay titles for clinical trials: Is industry achieving the balance? - Volume 32, Issue

Titles of clinical trials may directly influence whether patients, caretakers, or healthcare professionals will want to obtain more information about the trial. Major clinical trial registries require lay titles (referred to as “brief” or “public”…

Why clinical study reports really matter - Volume 27, Issue

Clinical study reports (CSRs) have so far served as documents for drug approval, but not as a data source for further use in research and post-regulatory decision-making. Sound post-regulatory decisions also require data other than those available…

Clinical evaluation reports: 6 years after the introduction of MEDDEV 2.7/1 revision 4 - Volume 31, Issue

MEDDEV 2.7/1 is the European guideline about the clinical evaluation of medical devices. The 4th revision, in 2016, updated how clinical evaluation should be conducted and reported, thus paving the way for clinical evaluation under the Medical…

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Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

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