Medical Writing Authors Thomas M. Schindler

Thomas M. Schindler

Contributions

Lay titles for clinical trials: A balancing act - Volume 27, Issue 2

With increasing transparency demands andthe new legal requirements for providingclinical trial information to lay readers, clinicaltrials need to be given titles that patients canunderstand and recognise. Trial titles informthe readers what the…

Clinical data publication by the EMA: The challenges facing the pharmaceutical industry - Volume 27, Issue 2

As of October 2016, EMA publishes clinicaldata on their clinical data website(https://clinicaldata.ema.europa.eu). Thisnew procedure applies to all marketingauthorisation applications submitted bypharmaceutical companies under thecentralised…

The perils of the unknown: Missing data in clinical studies - Volume 27, Issue 1

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…

Transferring regulation into practice: The challenges of the new layperson summary of clinical trial results - Volume 24, Issue 1

The new European Clinical Trials Regulation, published on 27 May 2014, requires sponsors to provide summary results of clinical trials in a format that is understandable to laypersons. The lay summary is to be made publicly available in the yet to…

Pharmaceutical medical writing competencies: Comparing self-perception with employers' expectations - Volume 21, Issue 3

In the recently published ‘Pharmaceutical Medical Writing Competency Model’, a group of medical writers describes the knowledge, skills, and behaviours they considered essential for successful medical writers. Thus, this model represents a list of…

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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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