PMID- 21220052
OWN - NLM
STAT- MEDLINE
DCOM- 20110601
LR  - 20220330
IS  - 1559-2030 (Electronic)
IS  - 1551-7144 (Linking)
VI  - 32
IP  - 2
DP  - 2011 Mar
TI  - Strategic lessons from the clinical event classification process for the 
      Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial.
PG  - 178-87
LID - 10.1016/j.cct.2010.12.013 [doi]
AB  - BACKGROUND: Independent adjudication of clinical trial events is traditionally 
      performed by physicians on a clinical event classification (CEC) committee. 
      OBJECTIVES: The experience of the centralized CEC group of the APEX-AMI trial is 
      described. This group adjudicated key secondary pre-specified outcome measures of 
      congestive heart failure (CHF) and cardiogenic shock through 90 days using an 
      algorithmic approach for some events. METHODS: Data were collected via an 
      electronic data capture (EDC) tool on all subjects, and additional information 
      was provided via EDC for patients identified by site investigators with CHF or 
      shock. Two strategies were used to adjudicate potential events: 1) a computer 
      algorithm (followed by physician confirmation) analyzed data to determine whether 
      events met trial end point definitions; or 2) physician review was used if EDC 
      data were inadequate to allow classification by algorithm. RESULTS: Of 5745 
      patients, 282 suspected cardiogenic shock and 465 suspected CHF events were 
      identified. The computer algorithm or physicians confirmed 196/282 cardiogenic 
      shock and 277/465 CHF end points. Overall, 242/742 (32.6%) of suspected events 
      were classified by algorithm. Of the 500 events not resolved by computer 
      algorithm, the CEC physicians agreed with site investigator assessments in 
      126/277 (45%) of CHF and 151/196 (77%) of cardiogenic shock events. The CEC 
      committee completed adjudication of all suspected 30- and 90-day CHF and 
      cardiogenic shock events within 7 days of the last patient 30-day follow-up visit 
      and within 1 day of the last patient 90-day follow-up visit. Only 27% of patients 
      required source document collection in addition to EDC-collected information. 
      CONCLUSIONS: A complementary approach of a computerized assessment and physician 
      review was used in the CEC effort of the APEX-AMI trial. The algorithm 
      categorized approximately one third of suspected CHF/cardiogenic shock events. 
      The APEX-AMI CEC experience shows that an algorithmic approach may be a useful 
      strategy for end point evaluation but requires validation.
CI  - Copyright (c) 2011 Elsevier Inc. All rights reserved.
FAU - Mahaffey, Kenneth W
AU  - Mahaffey KW
AD  - Duke Clinical Research Institute, Durham, NC 27705, USA. mahaf002@mc.duke.edu
FAU - Wampole, June L
AU  - Wampole JL
FAU - Stebbins, Amanda
AU  - Stebbins A
FAU - Berdan, Lisa G
AU  - Berdan LG
FAU - McAfee, Donna
AU  - McAfee D
FAU - Rorick, Tyrus L
AU  - Rorick TL
FAU - French, John K
AU  - French JK
FAU - Kleiman, Neal S
AU  - Kleiman NS
FAU - O'Connor, Christopher M
AU  - O'Connor CM
FAU - Cohen, Eric A
AU  - Cohen EA
FAU - Granger, Christopher B
AU  - Granger CB
FAU - Armstrong, Paul W
AU  - Armstrong PW
CN  - APEX-AMI Investigators
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110108
PL  - United States
TA  - Contemp Clin Trials
JT  - Contemporary clinical trials
JID - 101242342
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Cardiovascular Agents)
RN  - 0 (Single-Chain Antibodies)
RN  - CHZ6OLQ3UU (pexelizumab)
SB  - IM
MH  - Antibodies, Monoclonal/adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Bundle-Branch Block/drug therapy
MH  - Cardiovascular Agents/*therapeutic use
MH  - Diagnosis, Computer-Assisted/methods
MH  - Double-Blind Method
MH  - Heart Failure/diagnosis
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Myocardial Infarction/*drug therapy
MH  - Observer Variation
MH  - Randomized Controlled Trials as Topic/*methods/standards
MH  - Shock, Cardiogenic/diagnosis
MH  - Single-Chain Antibodies/adverse effects/*therapeutic use
MH  - Time Factors
EDAT- 2011/01/12 06:00
MHDA- 2011/06/02 06:00
CRDT- 2011/01/12 06:00
PHST- 2010/04/27 00:00 [received]
PHST- 2010/11/17 00:00 [revised]
PHST- 2010/12/29 00:00 [accepted]
PHST- 2011/01/12 06:00 [entrez]
PHST- 2011/01/12 06:00 [pubmed]
PHST- 2011/06/02 06:00 [medline]
AID - S1551-7144(11)00002-4 [pii]
AID - 10.1016/j.cct.2010.12.013 [doi]
PST - ppublish
SO  - Contemp Clin Trials. 2011 Mar;32(2):178-87. doi: 10.1016/j.cct.2010.12.013. Epub 
      2011 Jan 8.