Accrual to Clinical Trials (ACT): A Clinical and Translational Science Award Consortium Network

Shyam Visweswaran; Michael J Becich; Vincent S D'Itri; Elaina R Sendro; Douglas MacFadden; Nicholas R Anderson; Karen A Allen; Dipti Ranganathan; Shawn N Murphy; Elaine H Morrato; Harold A Pincus; Robert Toto; Gary S Firestein; Lee M Nadler; Steven E Reis

doi:10.1093/jamiaopen/ooy033

Accrual to Clinical Trials (ACT): A Clinical and Translational Science Award Consortium Network

JAMIA Open. 2018 Oct;1(2):147-152. doi: 10.1093/jamiaopen/ooy033. Epub 2018 Aug 21.

Authors

Affiliations

¹ Department of Biomedical Informatics, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
² The Chartis Group, Chicago, Illinois, USA.
³ The Harvard Clinical and Translational Science Center, Harvard Medical School, Boston, Massachusetts, USA.
⁴ Department of Public Health Sciences, University of California, Davis, California, USA.
⁵ Office of Research, University of California, Irvine, California, USA.
⁶ Academic Information Systems, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
⁷ Research Computing, Partners HealthCare, Charlestown, Massachusetts, USA.
⁸ Department of Health Systems, Management and Policy, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
⁹ Department of Psychiatry, Columbia University, New York, New York, USA.
¹⁰ The Center for Translational Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
¹¹ Altman Clinical and Translational Research Institute, University of California, San Diego, California, USA.
¹² The Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

Abstract

The Accrual to Clinical Trials (ACT) network is a federated network of sites from the National Clinical and Translational Science Award (CTSA) Consortium that has been created to significantly increase participant accrual to multi-site clinical trials. The ACT network represents an unprecedented collaboration among diverse CTSA sites. The network has created governance and regulatory frameworks and a common data model to harmonize electronic health record (EHR) data, and deployed a set of Informatics for Integrating Biology and the Bedside (i2b2) data repositories that are linked by the Shared Health Research Information Network (SHRINE) platform. It provides investigators the ability to query the network in real time and to obtain aggregate counts of patients who meet clinical trial inclusion and exclusion criteria from sites across the United States. The ACT network infrastructure provides a basis for cohort discovery and for developing new informatics tools to identify and recruit participants for multi-site clinical trials.

Keywords: accrual; clinical data research network; clinical trials; cohort discovery; electronic health records.

Abstract

Grants and funding