Open AccessAn audit of safety reporting in randomized controlled trials over a five-year period in a high impact factor journal
Author(s) -
Mahanjit Konwar,
A Mamde,
Panini Patankar,
Urmila M Thatte,
Nitin Gogtay
Publication year - 2022
Publication title -
journal of postgraduate medicine/journal of postgraduate medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.405
H-Index - 52
eISSN - 0972-2823
pISSN - 0022-3859
DOI - 10.4103/jpgm.jpgm_78_21
Subject(s) - medicine , randomized controlled trial , audit , confidence interval , clinical trial , family medicine , medline , management , economics , political science , law
Randomized controlled trials [RCTs] form the corner-stone of evidence-based medicine. RCTs published in high impact factor journals such as the New England Journal of Medicine [NEJM] are a key driver of clinical practice and policy decisions. RCTs are expected to report both efficacy and safety, however, safety reporting in many studies tends to be poor. The present audit was undertaken with the primary objective of evaluating safety reporting during a five-year period in all RCTs published in the NEJM.