PMID- 11813935
OWN - NLM
STAT- MEDLINE
DCOM- 20020712
LR  - 20190922
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 23
IP  - 12
DP  - 2001 Dec
TI  - Variability in the assessment of adverse events in a multicenter clinical trial.
PG  - 2011-20
AB  - BACKGROUND: Consistent documentation, characterization, and evaluation of adverse 
      events (AEs) are needed during multicenter clinical trials to ensure accuracy of 
      data reported to the US Food and Drug Administration and in the medical 
      literature. OBJECTIVE: The purpose of this study was to identify and characterize 
      variations in the assessment of AEs by clinical trial personnel. METHODS: During 
      the annual meeting of personnel from a multicenter, controlled clinical trial of 
      an investigational new drug treatment for opioid dependence, an oral presentation 
      of procedures for AE data collection was given to 25 principal investigators and 
      ancillary study personnel who assessed AEs for the study. A post-test using 3 
      hypothetical AE cases in which AEs were categorized by type of reaction, 
      relatedness to study drug, severity, action taken, and outcome was completed by 
      study participants. Cases and expected responses were reviewed for content and 
      validity by clinical research pharmacists who were not involved with the study. 
      The level of agreement with expected responses was assessed using McNemar 
      symmetry chi-square tests. RESULTS: Assessments of type of AE, relatedness to 
      study drug, and severity were less frequently aligned with expected responses 
      than were action taken and outcome (P < 0.013). Less consistency with expected 
      responses was found in I case than in the other 2, suggesting that certain types 
      of AEs may be more difficult to assess. CONCLUSIONS: There was considerable 
      variability in categorization of AEs in an exercise following training for AE 
      data collection. Type of report, relatedness, and severity were found to have 
      more variability in reporting than did action taken or outcome. The results 
      suggest that unless data are gathered to verify reliability of reporting, 
      subcategorization of AE data should be undertaken cautiously. Further research is 
      needed regarding methods for improving consistency in reporting of AEs.
FAU - Raisch, D W
AU  - Raisch DW
AD  - Department of Veterans Affairs Cooperative Studies Program Clinical Research 
      Pharmacy Coordinating Center, College of Pharmacy, University of New Mexico, 
      Albuquerque 87106, USA. dennis.raisch@csp.research.med.va.gov
FAU - Troutman, W G
AU  - Troutman WG
FAU - Sather, M R
AU  - Sather MR
FAU - Fudala, P J
AU  - Fudala PJ
LA  - eng
PT  - Journal Article
PT  - Research Support, U.S. Gov't, Non-P.H.S.
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
SB  - IM
MH  - *Clinical Trials as Topic
MH  - Documentation
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - *Multicenter Studies as Topic
MH  - Reproducibility of Results
MH  - *Research Personnel
EDAT- 2002/01/30 10:00
MHDA- 2002/07/13 10:01
CRDT- 2002/01/30 10:00
PHST- 2002/01/30 10:00 [pubmed]
PHST- 2002/07/13 10:01 [medline]
PHST- 2002/01/30 10:00 [entrez]
AID - S0149-2918(01)80153-3 [pii]
AID - 10.1016/s0149-2918(01)80153-3 [doi]
PST - ppublish
SO  - Clin Ther. 2001 Dec;23(12):2011-20. doi: 10.1016/s0149-2918(01)80153-3.