Searche

Your search for "clincial trial data" matched 55 page(s).

Showing results 31 to 40.

Estimands – closing the gap between study design and analysis - Volume 27, Issue

Estimands represent a new way to look at key aspects of clinical research and will become increasingly important for medical writers. Estimands are detailed definitions of quantities to be estimated using clinical trial data, which make allowance…

RCTs: Can the treatment work? Patient registries: Does the treatment work? - Volume 26, Issue

The first part of this article compares the main features of studies based on patient registry data with those of randomised clinical trials, providing a basis for better understanding the differences between the two. The second part details how to…

Regulatory submissions of non-interventional post-authorisation safety studies - Volume 26, Issue

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…

A primer on anonymisation - Volume 28, Issue

Canadian and European regulators finalised guidelines that allow for sharing of clinical trial data. To maintain the utility of clinical information, risk-based anonymisation techniques are recommended. It behoves applicants to ensure organisational…

Medical devices in the disclosure era and the role of medical writers - Volume 26, Issue

AbstractIncreased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven.…

Document management systems for medical writing - Volume 28, Issue

Clinical trial data are rightfully protected by robust regulations; given these requirements and increasing demands from clients, a validated and compliant electronic document management system is now a necessity for established medical writing…

Trends in regulatory writing: A brief overview for aspiring medical writers - Volume 28, Issue

The EU regulatory system is undergoing a major overhaul. Several new pieces of legislation are now in place to enforce harmonisation and transparency in clinical trials while ensuring data security and individual privacy. New and aspiring medical…

Leveraging infographics in study schemas - Volume 29, Issue

Data disclosure requirements of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) mandate that protocols be shared on designated clinical trial websites. As a visual medium, theinternet is transforming the way these…

Regulatory Writing - Volume 21, Issue

The discussion section of a clinical study report The discussion section of a clinical study report (CSR) is often a source of doubt among medical writers. The advice is usually to keep the discussion section as short as possible and not go…

Social media and altmetrics: The pharma perspective - Volume 30, Issue

The increased prevalence of healthcare-related social media and other web-based communications has generated interest in tools that measure the attention and engagement of published content. In the context of medical research publications, the use…

Visit the EMWA website

Search

Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Scope

Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

Medical Writing is listed in the following indexes: