Medical Writing Observational Studies

Volume 26, Issue 3 - Observational Studies

September 2017


Observations and Observational Studies

President's Message

President's Message



Feature Articles

RCTs: Can the treatment work? Patient registries: Does the treatment work?

Odd cases and risky cohorts: Measures of risk and association in observational studies

Guidance for the design and analysis of observational studies: The STRengthening Analytical Thinking for Observational Studies (STRATOS) initiative

Guidelines for disclosing the results from observational trials

Registration and ethics committee approval for observational studies: Current status and way forward

Regulatory submissions of non-interventional post-authorisation safety studies

Reporting non-interventional post-authorisation safety studies (NI-PASS)

Patient-reported outcomes: How useful are they?

EMA releases the revised Good Pharmacovigilance Practices Module V – updated guidance on risk management plans

Mentoring tomorrow’s medical writers

ICMJE to mandate data sharing statements

News from the EMA

News from the EMA

Regular Sections

Journal Watch

Getting Your Foot in the Door

In the Bookstores

Regulatory Matters

Medical Communications

The Webscout

Teaching Medical Writing

Good Writing Practice

Out On Our Own

Out on Our Own


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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:

Editoral Board



Managing Editor

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Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: