Medical Writing Observational Studies RCTs: Can the treatment work? Patient registries: Does the treatment work?
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Volume 26, Issue 3 - Observational Studies

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

Abstract

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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References

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Observations and Observational Studies
President's Message
EMWA News
RCTs: Can the treatment work? Patient registries: Does the treatment work?
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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
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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
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