Thomas M. Schindler

Contributions

Lay titles for clinical trials: Is industry achieving the balance? - Volume 32, Issue 1

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”…

Medical Communications and Writing for Patients - Volume 30, Issue 4

Dear All, As I’m sure you are aware, EMWA’s Special Interest Groups (SIGs) have been hard at work hosting “Meet & Share” sessions throughout the year. These sessions aim to encourage open and honest discussion between medical writers on a…

News and Notes from the World of Medical Writing - Volume 30, Issue 3

EMWA’s Special Interest Group on Medical Communication initiated a reply to an article that made unfounded derogatory remarks about medical writers (MWs). Without providing any evidence, in an article about the development of randomised clinical…

Presenting secondary endpoints in plain language clinical trial result summaries: Considerations for emerging practice - Volume 30, Issue 2

Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…

Lay summaries for Phase 1 trials in healthy volunteers - Volume 29, Issue 4

Lay summaries of Phase I trials in healthy volunteers pose a challenge because their endpoints are complex, the targeted indication may not be known when they are conducted, their results are often reported years after the trial ended, and the…

Enhancing accessibility of study data: The development of a graphical abstract for lay summaries of clinical trial results - Volume 29, Issue 1

We describe the development of a graphical abstract for lay summaries of clinical trial results. The new graphical summary serves the same purpose for a lay summary as an abstract does for a scientific publication. Lay summaries are intended to…

Predatory publishing – what medical communicators need to know - Volume 28, Issue 3

The rise of ”predatory journals”, also known as pseudo-scientific journals, poses a risk to the integrity of science and therefore medical communicators need to know about their practices. Upon receipt of a publication fee, predatory journals…

Estimands – closing the gap between study design and analysis - Volume 27, Issue 4

Estimands represent a new way to look at key aspects of clinical research and will become increasingly important for medical writers. Estimands are detailed definitions of quantities to be estimated using clinical trial data, which make allowance…

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…