PMID- 21854288
OWN - NLM
STAT- MEDLINE
DCOM- 20111214
LR  - 20131121
IS  - 1097-9891 (Electronic)
IS  - 0095-2990 (Linking)
VI  - 37
IP  - 5
DP  - 2011 Sep
TI  - Strategies for safety reporting in substance abuse trials.
PG  - 440-5
LID - 10.3109/00952990.2011.602996 [doi]
AB  - BACKGROUND: Reporting all adverse events (AEs) and serious adverse events (SAEs) 
      in substance use disorder (SUD) clinical trials has yielded limited relevant 
      safety information and has been burdensome to research sites. OBJECTIVE: This 
      article describes a new strategy utilizing standard data elements for AE and SAEs 
      that defines a threshold to reduce unnecessary safety reporting burden in SUD 
      clinical trials and describes retrospective review and prospective preliminary 
      data on the strategy's safety reporting impact. METHODS: We developed a new 
      strategy to standardize safety reporting and tailor reporting to the trial 
      intervention risk. Protocols and safety data from 17 SUD clinical trials were 
      reviewed. Retrospective analysis of five of these studies and prospective 
      application to new studies is described. RESULTS: Across the 17 previously 
      completed trials, a total of 11,220 AEs and 1330 SAEs were reported in the 6737 
      participants. Wide variability in AE and SAE reporting rates were noted based on 
      trial type and inconsistent reporting strategies. Application of the new, 
      tailored safety strategy retrospectively and prospectively reduces reporting 
      burden of irrelevant safety events. CONCLUSION: Comparison of the previous 
      reporting strategies used in SUD trials to the new strategy demonstrates a more 
      consistent safety system with a reduction in safety reporting burden while 
      maintaining appropriate safety monitoring. SCIENTIFIC SIGNIFICANCE: Safety 
      assessments should be tailored to the participant risks based on the trial 
      intervention. The current strategies could be applied to safety assessments 
      across all clinical trials in SUDs.
FAU - Lindblad, Robert
AU  - Lindblad R
AD  - The EMMES Corporation, Rockville, MD, USA. rlindblad@emmes.com
FAU - Campanella, Maria
AU  - Campanella M
FAU - Styers, David
AU  - Styers D
FAU - Kothari, Prasad
AU  - Kothari P
FAU - Sparenborg, Steve
AU  - Sparenborg S
FAU - Rosa, Carmen
AU  - Rosa C
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, U.S. Gov't, Non-P.H.S.
PL  - England
TA  - Am J Drug Alcohol Abuse
JT  - The American journal of drug and alcohol abuse
JID - 7502510
SB  - IM
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - National Institute on Drug Abuse (U.S.)
MH  - Prospective Studies
MH  - Randomized Controlled Trials as Topic/*methods
MH  - *Research Design
MH  - Retrospective Studies
MH  - Risk
MH  - Substance-Related Disorders/*drug therapy/rehabilitation
MH  - United States
EDAT- 2011/08/23 06:00
MHDA- 2011/12/15 06:00
CRDT- 2011/08/23 06:00
PHST- 2011/08/23 06:00 [entrez]
PHST- 2011/08/23 06:00 [pubmed]
PHST- 2011/12/15 06:00 [medline]
AID - 10.3109/00952990.2011.602996 [doi]
PST - ppublish
SO  - Am J Drug Alcohol Abuse. 2011 Sep;37(5):440-5. doi: 10.3109/00952990.2011.602996.