Art Gertel

Contributions

HTA decision-making: Do ethics matter? - Volume 30, Issue 3

Before reviewing the article in this issue of Medical Writing by Larry Liberti and Tina Wang, The regulatory-HTA decision-making interface: What the medical writer should know (p. 50), I put on my ethicist’s hat. Thus, I tuned my ethics antennae to…

Promoting equity in understanding: A cross-organisational plain language glossary for clinical research - Volume 29, Issue 4

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…

Rush to publication – What do we have to lose? - Volume 29, Issue 2

Just as the research and development of new drugs requires careful, often painstaking, adherence to empirical processes, the peer-review process and, indeed, the manuscript preparation process, are likewise laborious and time-consuming. The benefits…

EMWA News - Volume 28, Issue 1

Last year, the November conference in Warsaw reached a record of attendees. Now, we are two months away from the annual spring conference in the beautiful city of Vienna, and we are beyond excited. This time, the 7th EMWA Symposium will focus on…

A history of EMWA - Volume 27, Issue 1

EMWA has now been in existence for 25 years! How is that possible? Time has flown by, and brought with it much change and growth of which we should be proud. This is an oppor tunity to reflect back on the organisation as it was at its genesis, is…

Lingua Franca and Beyond - Volume 24, Issue 4

Knowing that the main theme of this issue of Medical Writing is writing for the lay audience, I was thinking hard about what would be the most relevant topic to discuss in the Lingua Franca and Beyond section. My thoughts went to a topic that…

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 4

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…

If a misinformed voice speaks out in the wilderness and no one refutes it, does it make a sound? A call to advocacy - Volume 22, Issue 4

The pharmaceutical industry has been a soft target for many years. Attacks by journalists, politicians, and the lay public tend to be triggered by publications with which professional medical writers are associated. Fault is found, either in the…