Clinical trial transparency and disclosure from the medical writing perspective - Volume 33, Issue

It’s been more than 6 years since our last Medical Writing edition dedicated to clinical trial transparency and disclosure. Since then, we have seen the full implementation of the long-awaited EU Clinical Trials Regulation (CTR), the pause and restar…

Medical Writing explores the many faces of Biotechnology - Volume 32, Issue

This Medical Writing issue focuses on the crucial role of medical writing and communications in biotechnology and product development in healthcare. In the pharmaceutical and medical device industries, biotechnology uses biological systems and…

Artificial Intelligence and Machine Learning - Volume 32, Issue

Guest Editors Daniela Kamir and Shiri Diskin provide an introduction to this issue, whose theme Artificial Intelligence and Machine Learning. We are in an era in which most people cannot imagine living without either computers or smartphones. We…

The use of machine translation and AI in medical translation: pros and cons - Volume 33, Issue

In this article, I provide a retrospective look at the emergence of translation technologies and summarise the pros and cons of the use of neural machine translation and generative AI tools in medical translation. I will examine both the advantages…

Artificial Intelligence and Machine Learning - Volume 32, Issue

Jackline Odhiambo

Pauline Haleux

Writing for orphan drugs: A compass to navigate document types and regional requirements - Volume 34, Issue

Medical writing for rare diseases encompasses the development of various regulatory documents that are required to obtain orphan drug designation and marketing authorisation for treatments targeting rare conditions. Effective planning and close…

Artificial intelligence – will we be replaced by robots? - Volume 28, Issue

Advances in artificial intelligence (AI) increasingly dominate the news with billions of dollars in funding invested to combine AI with machine learning and data science across many disciplines, including medicine and healthcare. Within the context…

Regulatory initiatives for artificial intelligence applications: Regulatory writing implications - Volume 32, Issue

Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…