Volume 26, Issue 3 - Observational Studies
Observations and Observational Studies
Author: Phil Leventhal
Abstract
Our publication, Medical Writing, has always been a work in progress, continually evolving to meet our members’ needs and desires. Originally a four-page newsletter called the EMWA Newsletter, it was renamed The Write Stuff in 1998 and, under the guidance of Elise Langdon-Neuner, grew to a larger publication renamed Medical Writing in 2011. Since taking over as Editor in 2012, I have focused on shifting Medical Writing to an in-house publication and to a more dynamic format.
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Observations and Observational Studies
President's Message
EMWA News
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
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Getting Your Foot in the Door
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Victoria White
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Alison McIntosh / Stephen Gilliver
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Chris Monk