Integrating ancillary studies in a large clinical trial: the design and rationale of the APEX library.
The APEX library was a coordinated and integrated set of ancillary analyses and substudies that were a part of the large APEX-AMI trial. The library included electrocardiogram, angiographic, blood biomarker, genetics, and MRI components. Operationally, the goals and administration of the APEX library were developed concurrently with the design of the parent trial. The goal recruitment in the library was met due to this approach. These data will provide important insights into the pathobiology of acute myocardial infarction and the relationships between inflammation, thrombosis, genetics, and classic clinical markers from angiograms, electrocardiograms, and patient demographics. In conclusion, the APEX library is an example of successful collaboration among academic trial leaders, site investigators, and pharmaceutical sponsors. The operational paradigm of this effort should be considered in future investigations so that important advances in clinical care of disease can be realized efficiently.
Mahaffey
Kenneth W
KW
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA. mahaf002@mc.duke.edu
Reist
Craig J
CJ
Fu
Yuling
Y
Brener
Sorin J
SJ
Theroux
Pierre
P
Patel
Manesh R
MR
Stebbins
Amanda
A
Westerhout
Cynthia M
CM
Todaro
Thomas G
TG
Adams
Peter X
PX
Granger
Christopher B
CB
Armstrong
Paul W
PW
D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D015415:Biomarkers; D035843:Biomedical Research / Q000379:methods*; D002986:Clinical Trials as Topic; D003328:Coronary Thrombosis; D004311:Double-Blind Method; D006801:Humans; D007249:Inflammation; D008279:Magnetic Resonance Imaging; D015337:Multicenter Studies as Topic; D015425:Myocardial Reperfusion / Q000379:methods; D012107:Research Design; D057127:Single-Chain Antibodies
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D015415:Biomarkers; D057127:Single-Chain Antibodies; C402724:pexelizumab