PMID- 27567767
OWN - NLM
STAT- MEDLINE
DCOM- 20170717
LR  - 20170817
IS  - 1878-6847 (Electronic)
IS  - 0924-6479 (Linking)
VI  - 28
IP  - 2
DP  - 2016 Aug 22
TI  - Adverse event assessment methods in published trials of psychotropic drugs: Poor 
      reporting and neglect of emerging safety concerns.
PG  - 101-14
LID - 10.3233/JRS-160723 [doi]
AB  - BACKGROUND: Actual assessment methods for identifying adverse events (AEs) in 
      clinical trials have received less scrutiny than underreporting of AEs. 
      OBJECTIVE: To investigate whether AE assessment has changed over time for three 
      psychotropic drugs with turbulent histories of safety concerns since their U.S. 
      approval. METHODS: From industry-funded published trials of atomoxetine, 
      duloxetine, and olanzapine retrieved from PubMed for 1996-2004 (n = 33) and 
      2009-2014 (n = 40), verbatim AE assessment and numbers of words describing 
      efficacy and safety assessment were extracted. RESULTS: Closest to drug approval 
      (1996-2004), 77.8% of atomoxetine trials used open-ended questioning only, 50% of 
      duloxetine trials used spontaneous self-report or clinician observation only, and 
      66.7% of olanzapine trials used a scale (primarily for extrapyramidal symptoms) 
      and one former method. Recent studies (2009-2014) showed less rigor and 
      transparency: 35.3% of atomoxetine and 64.7% of duloxetine studies reported no AE 
      assessment method and 50% of olanzapine studies no longer used scales. Overall, 
      the mean number of words describing efficacy assessment increased from 202 to 309 
      but decreased from 83 to 63 for safety. CONCLUSION: Trial methodology for 
      assessing psychotropic drug safety remains an underdeveloped area with major 
      public health implications.
FAU - Hughes, Shannon
AU  - Hughes S
AD  - School of Social Work, College of Health and Human Sciences, Colorado State 
      University, Fort Collins, CO, USA.
FAU - Cohen, David
AU  - Cohen D
AD  - Luskin School of Public Affairs, University of California, Los Angeles, CA, USA.
FAU - Johnson, Rebekah
AU  - Johnson R
AD  - Milwaukee, WI, USA.
LA  - eng
PT  - Journal Article
PL  - Netherlands
TA  - Int J Risk Saf Med
JT  - The International journal of risk & safety in medicine
JID - 9100907
RN  - 0 (Psychotropic Drugs)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/standards/statistics & numerical data
MH  - Clinical Trials as Topic/methods/standards
MH  - Disclosure
MH  - Drug-Related Side Effects and Adverse Reactions/*diagnosis/etiology
MH  - Humans
MH  - Needs Assessment
MH  - Patient Outcome Assessment
MH  - Psychotropic Drugs/*adverse effects
MH  - Quality Improvement
MH  - Research Design/standards
OTO - NOTNLM
OT  - Drug safety
OT  - adverse events
OT  - clinical trial methodology
OT  - psychotropic drugs
EDAT- 2016/08/29 06:00
MHDA- 2017/07/18 06:00
CRDT- 2016/08/29 06:00
PHST- 2016/08/29 06:00 [entrez]
PHST- 2016/08/29 06:00 [pubmed]
PHST- 2017/07/18 06:00 [medline]
AID - JRS723 [pii]
AID - 10.3233/JRS-160723 [doi]
PST - ppublish
SO  - Int J Risk Saf Med. 2016 Aug 22;28(2):101-14. doi: 10.3233/JRS-160723.