Good Publication Practice (GPP) Guidelines Help To Define the Role of Professional Medical Writers in Research Publication

All medical communicators need to adhere to a strong set of ethics and standards. In particular, regulatory medical writers who collaborate on company‑sponsored biomedical research projects are part of a chain of responsibility for accurately reporting the results of clinical trials.

Manuscript Editing: Tools and Tips for Medical Communicators

Every document improves with editing, and medical editors are key to the process of creating consistent, readable, and error-free manuscripts.

What are the fundamentals of manuscript editing for medical communicators? What are editors looking for when they edit manuscripts? What tools are available when editors seek to create high-quality manuscripts?

The Promise and Possibility of Open Access Publishing

Open access (OA) publishing is a model of publishing that mainly shifts the costs of publishing an article from the reader to the authors and distributes scholarly works online without paywalls or other barriers.

The concept of open access is part of a larger movement called Open Science that seeks to make scientific documents, data, and research more accessible and equitable.

Understanding Authorship in a Changing World

AMWA acknowledges the contributions of Crystal Herron PHD, ELS, as lead content developer, and Michelle Sauer Gehring PHD, ELS, for peer review, in the development of this AMWA resource.

As the world moves in a more interconnected, digital, and collaborative direction, best practices in authorship have become less straightforward. 

Medical writers may find themselves contributing to manuscripts in many ways and might encounter problematic examples of ghost authorship, gift authorship, and guest authorship.

The CONSORT Statement: A Standard for Reporting Randomized Controlled Trials

Randomized controlled trials (RCTs) are the foundation for advancing clinical practice. However, not all RCTs are created equal. To communicate how an RCT was designed and what it found, authors must report clear and accurate information about its methodology and results. Unfortunately, many reviews have shown that authors often don’t provide complete and transparent information about the clinical trial, which can lead to misinterpretation of the validity and reliability of the results. 

ICMJE Authorship Guidelines and Acknowledging Non-author Contributions

Scientific manuscripts are rarely the work of one author. They are the result of complex collaborative relationships. This reality begs the questions: Who is the author of a scientific manuscript? When is someone credited as an author, and when are they considered a non-author contributor?