Safety reporting in randomized clinical trials - a need for improvement.
The reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking in the publication of trials. Part of the problem is the way safety data are reported in RCTs. Reporting of "time to event," use of standardized incidence ratios for comparison to normal population or disease controls, use of "patient years" when reporting AE, and adequate sample size and power calculations are some of the problems that need to be addressed and improved in RCTs.
Yazici
Yusuf
Y
New York University School of Medicine, New York, NY, USA. yusuf.yazici@nyumc.org
D016907:Adverse Drug Reaction Reporting Systems; D018501:Antirheumatic Agents / Q000009:adverse effects*; D019317:Evidence-Based Medicine; D006801:Humans; D010506:Periodicals as Topic / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D015203:Reproducibility of Results; D018570:Risk Assessment; D018401:Sample Size; D009626:Terminology as Topic; D013997:Time Factors; D016896:Treatment Outcome
D018501:Antirheumatic Agents