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

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…

Regulatory Matters - Volume 28, Issue

Changes in the regulatory landscape and changes in our professional environment make this an exciting time to be part of the regulatory medical writing community. It is a time when new opportunities are presenting and when, like never before, the…

Science communication: A guide to creating online scientific content that engages - Volume 30, Issue

Science communication plays an important role in educating the public about scientific knowledge. Until recently, publishing in research journals and presenting at science conferences were the only options available to scientists for sharing their…

Preventing biomedical research waste - Volume 31, Issue

An estimated 85% of efforts in biomedical research are wasted due to inefficiencies. This wastage represents a global financial loss of greater than US$200 billion per year, a barrier to practicing evidence-based medicine, and a considerable amount…

The past - the present - the future - Volume 31, Issue

Dear colleagues, friends, and EMWA members,Happy 30th EMWA anniversary!We have an exciting new year ahead of us. To celebrate EMWA’s 30th anniversary, we will take a deep dive into EMWA’s history, celebrate our present accomplishments, and aim to…

Fake news and vaccination: How the Science Anti-Fake News team in Argentina is fighting the infodemic - Volume 31, Issue

At the outset of the pandemic, it became clear that misinformation (“fake news”) on COVID-19 was spreading rapidly. In this article, we discuss our efforts to combat misinformation by joining with researchers from various disciplines in Argentina to…

Elisabeth Heseltine

The 2023 CORE Reference Utility Survey: Perceptions on a best practice tool for globally applicable clinical study reporting and provision of continuing professional development resources for the regulatory medical writing community - Volume 33, Issue

CORE Reference offers globally applicable resources for clinical study reporting, including a user manual and a mapping tool, and continuous professional development (CPD) resources. This report presents the results of the 2023 Utility Survey conduct…

Update of the Consolidated Health Economic Evaluation Reporting Standards: CHEERS 2022 - Volume 31, Issue

If economic evaluations are to be used by researchers and healthcare decision makers, they need to be adequately reported. This article discusses the update of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022), the main…

To bias or not to bias in oncology clinical trials: Perspectives on design, endpoint selection, and reporting - Volume 32, Issue

Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands,…