PMID- 32897808
OWN - NLM
STAT- MEDLINE
DCOM- 20211125
LR  - 20211125
IS  - 1520-5711 (Electronic)
IS  - 1054-3406 (Linking)
VI  - 30
IP  - 6
DP  - 2020 Nov 1
TI  - Enhancing clarity of clinical trial safety reports for data monitoring 
      committees.
PG  - 1147-1161
LID - 10.1080/10543406.2020.1815034 [doi]
AB  - A Data Monitoring Committee (DMC) evaluates patient safety in a clinical trial of 
      an investigational intervention through periodic review of adverse events (AEs) 
      and clinical safety assessments. Our aim was to construct DMC report displays to 
      enhance the DMC safety review through use of graphics and clear identification 
      and adjustment for missing data caused by early discontinuations and ongoing 
      study participation. Suggested displays include a study snapshot graph, enhanced 
      adverse event incidence tables including the incidence density and plotted 
      incidence proportions, line graphs in place of by-patient listings, and trend 
      plots in place of tables for continuous assessments.
FAU - Thomas, Sonia M
AU  - Thomas SM
AUID- ORCID: 0000-0003-1362-5627
AD  - Division of Biostatistics and Epidemiology, RTI International, Research Triangle 
      Park, NC, USA.
FAU - Jung, Kwanhye
AU  - Jung K
AD  - Collaborative Studies Coordinating Center, Department of Biostatistics, 
      University of North Carolina, Chapel Hill, NC, USA.
FAU - Sun, Hengrui
AU  - Sun H
AD  - Division of Biometrics IV, Office of Biostatistics, Center for Drug Evaluation 
      and Research, US Food and Drug Administration, Silver Spring, MD, USA.
FAU - Psioda, Matthew A
AU  - Psioda MA
AD  - Collaborative Studies Coordinating Center, Department of Biostatistics, 
      University of North Carolina, Chapel Hill, NC, USA.
FAU - Quibrera, Pedro Miguel
AU  - Quibrera PM
AD  - Collaborative Studies Coordinating Center, Department of Biostatistics, 
      University of North Carolina, Chapel Hill, NC, USA.
FAU - Strakowski, Stephen M
AU  - Strakowski SM
AD  - Department of Psychiatry, Dell Medical School, University of Texas, Austin, TX, 
      USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200908
PL  - England
TA  - J Biopharm Stat
JT  - Journal of biopharmaceutical statistics
JID - 9200436
SB  - IM
MH  - *Clinical Trials Data Monitoring Committees
MH  - Humans
OTO - NOTNLM
OT  - Data monitoring committee
OT  - adverse event
OT  - clinical trial
OT  - data and safety monitoring board
OT  - graphical displays
OT  - incidence density
OT  - patient drop-out
OT  - safety data
EDAT- 2020/09/09 06:00
MHDA- 2021/11/26 06:00
CRDT- 2020/09/08 17:11
PHST- 2020/09/09 06:00 [pubmed]
PHST- 2021/11/26 06:00 [medline]
PHST- 2020/09/08 17:11 [entrez]
AID - 10.1080/10543406.2020.1815034 [doi]
PST - ppublish
SO  - J Biopharm Stat. 2020 Nov 1;30(6):1147-1161. doi: 10.1080/10543406.2020.1815034. 
      Epub 2020 Sep 8.