Medical Writing Observational Studies RCTs: Can the treatment work? Patient registries: Does the treatment work?

Volume 26, Issue 3 - Observational Studies

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


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 report study-specific issues with patient registries, such as study objectives, patient populations,
bias, confounders, missing data, study duration, and gives a few tips on how to improve the credibility of papers based on patient registry data.
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Observations and Observational Studies
President's Message
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
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

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  • Victoria White (Tampa, Florida, USA) Email:
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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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