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)…

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…

CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure - Volume 27, Issue

CORE Reference (www.core-reference.org) facilitates the authoring of a content-driven clinical study report (CSR) that is as “public disclosure-ready” as possible. It has potential to increase the quality of final CSRs and enhance consistency within…

Sunshine spreading across the Atlantic and over Europe - Volume 22, Issue

The quest for transparency in the relationships between life sciences companies and healthcare professionals is quickly becoming a global movement. Reporting requirements for financial interactions have been prevalent in the United States for many…

Clinical Trial Transparency and Disclosure - Volume 33, Issue

Transparency and public disclosure: What climate research can learn from clinical research – and vice versa - Volume 31, Issue

The healthcare industry is spearheading initiatives for public disclosure, open access, and plain language summaries in biomedical research. These initiatives are being mirrored in other fields of research as well, including climate research. Below…

From the Editor - Volume 33, Issue

The clinical research transparency journey Medical Writing. 2024;33(3):6–7. https://doi.org/10.56012/djjd9152

Ethical challenges in acknowledging professional writing support - Volume 29, Issue

Professional medical writers have an important role in facilitating the accurate and timely dissemination of medical and scientific data. This support should be appropriately acknowledged in peer-reviewed publications, but guidance on how to…

Transferring regulation into practice: The challenges of the new layperson summary of clinical trial results - Volume 24, Issue

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…

President’s Message - Volume 33, Issue

Navigating the new era of clinical trial transparency This issue of Medical Writing comes at a time when the summer holidays are behind us. Here’s hoping it has been a relaxing and rejuvenating time for all. As we get back to our day-to-day work,…