Integrating ancillary studies in a large clinical trial: The design and rationale of the APEX library

• Published in: Contemporary clinical trials Vol. 29; no. 6; pp. 887 - 895
• Main Authors: Mahaffey, Kenneth W., Reist, Craig J., Fu, Yuling, Brener, Sorin J., Theroux, Pierre, Patel, Manesh R., Stebbins, Amanda, Westerhout, Cynthia M., Todaro, Thomas G., Adams, Peter X., Granger, Christopher B., Armstrong, Paul W.
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.11.2008; Elsevier
• Subjects: Angioplasty, Balloon, Coronary; Antibodies, Monoclonal - pharmacology; Antibodies, Monoclonal - therapeutic use; Antibodies, Monoclonal, Humanized; Biological and medical sciences; Biomarkers; Biomedical Research - methods; Cardiovascular; Clinical trial. Drug monitoring; Clinical trials; Clinical Trials as Topic; Coronary Thrombosis; Double-Blind Method; General pharmacology; Hematology, Oncology, and Palliative Medicine; Humans; Inflammation; Library substudy; Magnetic Resonance Imaging; Medical sciences; Multicenter Studies as Topic; Myocardial Reperfusion - methods; Pharmacology. Drug treatments; Research Design; Single-Chain Antibodies; Library substudy; Clinical trials; Human; Immunomodulator; Myocardial infarction; Multicenter study; Cardiovascular disease; Clinical trial; Library; Pexelizumab; Coronary heart disease; Myocardial disease
• ISSN: 1551-7144; 1559-2030; 1559-2030
• DOI: 10.1016/j.cct.2008.06.003

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.