PMID- 27031396
OWN - NLM
STAT- MEDLINE
DCOM- 20160811
LR  - 20220317
IS  - 1326-5377 (Electronic)
IS  - 0025-729X (Linking)
VI  - 204
IP  - 6
DP  - 2016 Apr 4
TI  - Serious adverse event reporting in investigator-initiated clinical trials.
PG  - 231-3
AB  - Reporting adverse events (AEs) and serious AEs (SAEs) are practical steps to 
      ensure safety for volunteers and patients in medical research involving 
      medications, treatments and devices. However, the burden and cost of reporting 
      should be proportionate with the public health benefit of this information. 
      Unfortunately, in Australia there is clear evidence of ever-increasing 
      requirements from sponsors and ethics committees to report AEs and SAEs 
      unnecessarily, leading to a decrease in the uptake of research, particularly less 
      well funded investigator-initiated trials. We believe that individual AE reports 
      to ethics committees serve no useful purpose, because in most cases the study 
      group identity (drug exposure) is not known in studies with blinded treatment 
      arms and their value is limited. Pragmatic, investigator-initiated Phase IV 
      clinical trials of post-marketed drugs or devices are needed to understand their 
      role in everyday clinical practice. In this setting, the workload and costs of 
      systematic, complete reporting of all AEs and SAEs (independent of whether these 
      are treatment-related) is wasteful, and mostly unnecessary. A trial data safety 
      and monitoring committee is in the unique position of being able to review safety 
      information according to the blinded treatment arms of the study. This enables 
      safety data to be analysed appropriately and a summary report provided to the 
      trial steering committee, principal investigators and the relevant ethics 
      committees in a meaningful way. Defined trial endpoints do not need to be 
      reported as safety events (because they are being properly monitored and 
      analysed).
FAU - Wallace, Sophie
AU  - Wallace S
AD  - Alfred Hospital, Melbourne, VIC p.myles@alfred.org.au.
FAU - Myles, Paul S
AU  - Myles PS
AD  - Alfred Hospital, Melbourne, VIC.
FAU - Zeps, Nikolajs
AU  - Zeps N
AD  - St John of God Perth Northern Hospitals, Perth, WA.
FAU - Zalcberg, John R
AU  - Zalcberg JR
AD  - Monash University, Melbourne, VIC.
LA  - eng
PT  - Journal Article
PL  - Australia
TA  - Med J Aust
JT  - The Medical journal of Australia
JID - 0400714
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Australia
MH  - *Clinical Trials as Topic
MH  - Humans
MH  - Research Personnel
EDAT- 2016/04/01 06:00
MHDA- 2016/08/12 06:00
CRDT- 2016/04/01 06:00
PHST- 2015/09/04 00:00 [received]
PHST- 2015/12/04 00:00 [accepted]
PHST- 2016/04/01 06:00 [entrez]
PHST- 2016/04/01 06:00 [pubmed]
PHST- 2016/08/12 06:00 [medline]
AID - 10.5694/mja15.01007 [pii]
AID - 10.5694/mja15.01007 [doi]
PST - ppublish
SO  - Med J Aust. 2016 Apr 4;204(6):231-3. doi: 10.5694/mja15.01007.