Medical Writing Observational Studies Registration and ethics committee approval for observational studies: Current status and way forward
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Volume 26, Issue 3 - Observational Studies

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

Abstract

Randomised controlled trials (RCTs) have always been recognised as the highest level of evidence in medical research. However, they cannot address the questions that one comes across in real-world clinical practice. Observational studies can answer such questions as they are based upon real data obtained from patient healthcare records, medical databases, and registries. Literature review has shown that observational studies are as important as RCTs and should be considered when making any clinical decisions. However, there is a lack of standard guidelines for registering and reporting observational studies, which may contribute to publication and reporting bias.  Furthermore, guidelines differ on the ethical considerations for observational studies.  This article discusses these issues, focusing on the current situation and gaps in the registration, ethics approval, and publication of observational studies.
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