PMID- 19583556
OWN - NLM
STAT- MEDLINE
DCOM- 20090828
LR  - 20090708
IS  - 1936-9719 (Print)
IS  - 1936-9719 (Linking)
VI  - 67
IP  - 2
DP  - 2009
TI  - Safety reporting in randomized clinical trials - a need for improvement.
PG  - 209-10
AB  - 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.
FAU - Yazici, Yusuf
AU  - Yazici Y
AD  - New York University School of Medicine, New York, NY, USA. yusuf.yazici@nyumc.org
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Bull NYU Hosp Jt Dis
JT  - Bulletin of the NYU hospital for joint diseases
JID - 101300541
RN  - 0 (Antirheumatic Agents)
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Antirheumatic Agents/*adverse effects
MH  - Evidence-Based Medicine
MH  - Humans
MH  - *Periodicals as Topic/standards
MH  - *Randomized Controlled Trials as Topic/standards
MH  - Reproducibility of Results
MH  - Risk Assessment
MH  - Sample Size
MH  - Terminology as Topic
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2009/07/09 09:00
MHDA- 2009/08/29 09:00
CRDT- 2009/07/09 09:00
PHST- 2009/07/09 09:00 [entrez]
PHST- 2009/07/09 09:00 [pubmed]
PHST- 2009/08/29 09:00 [medline]
PST - ppublish
SO  - Bull NYU Hosp Jt Dis. 2009;67(2):209-10.