Making the leap: Transparency requirements for clinical trials moving from one regulatory framework to another - Volume 33, Issue

This article discusses the fast-approaching deadline for sponsors to transition ongoing clinical trials in the EU/European Economic Area from the Clinical Trials Directive 2001/20/EC to the Clinical Trials Regulation 536/2014. In particular, the…

Writing in plain language for the Summary of Safety and Clinical Performance: Communicating medical device safety and performance data to patients - Volume 34, Issue

Effective communication with patients is paramount in the medical field, particularly in the medical device sector, where the complexity of information can create barriers to understanding. The Summary of Safety and Clinical Performance (SSCP) has…

Transparency through the lens of data protection and privacy: A clinical research organisation medical writing perspective - Volume 33, Issue

Medical writers maintain a fine balance between data transparency obligations and personal data protection in clinical reports. Hence, we must stay informed of data protection requirements outlined in the EU General Data Protection Regulation (GDPR)…

Regulatory Matters - Volume 30, Issue

Calling all medical writers:

Focus your writing with lean authoring

In today’s medical writing environment, authors are routinely faced with expedited timelines to write documents about highly complex studies with overwhelming amounts of data. Revi…

Lay summaries and writing for patients: Where are we now and where are we going? - Volume 28, Issue

We examine the trend for increasing and more transparent patient information and ask how close we have come in the last few years to producing useful and meaningful information for patients. We also outline the challenges faced by medical writers…

Regulatory Public Disclosure - Volume 33, Issue

Section Editor and Author: Sam Hamilton   Medical Writing. 2024;33(3):95–100. https://doi.org/10.56012/vhdv1639

Regulatory Matters - Volume 32, Issue

Current clinical trial disclosure landscape in China Author and Section Editor: Zuo Yen Lee Section Editor: Clare Chang In China, before the launch of the current national clinical trial registry in 2013, i.e., ChinaDrugTrials.org.cn…

Regulatory Matters - Volume 32, Issue

Systems biology and real-world data as drivers of change in drug research and development In recent years, systems biology is not only being applied in fundamental science but also in drug development and healthcare. The application of real-world…

Regulatory Public Disclosure - Volume 32, Issue

Editorial Sam Hamilton (author and section editor) Medical Writing. 2023;32(3):91–95. https://doi.org/10.56012/hnnl8161 Clinical Data Publication (Policy 0070) relaunch Alison McIntosh (author) In preparation for the relaunch of EMA Clinical…

A beginner´s guide to writing clinical investigation plans and reports for medical devices - Volume 31, Issue

A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of  the statistical analysis. A…