The NIAID Division of AIDS enterprise information system: integrated decision support for global clinical research programs

Abstract

The National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) Enterprise Information System (DAIDS-ES) is a web-based system that supports NIAID in the scientific, strategic, and tactical management of its global clinical research programs for HIV/AIDS vaccines, prevention, and therapeutics. Different from most commercial clinical trials information systems, which are typically protocol-driven, the DAIDS-ES was built to exchange information with those types of systems and integrate it in ways that help scientific program directors lead the research effort and keep pace with the complex and ever-changing global HIV/AIDS pandemic. Whereas commercially available clinical trials support systems are not usually disease-focused, DAIDS-ES was specifically designed to capture and incorporate unique scientific, demographic, and logistical aspects of HIV/AIDS treatment, prevention, and vaccine research in order to provide a rich source of information to guide informed decision-making. Sharing data across its internal components and with external systems, using defined vocabularies, open standards and flexible interfaces, the DAIDS-ES enables NIAID, its global collaborators and stakeholders, access to timely, quality information about NIAID-supported clinical trials which is utilized to: (1) analyze the research portfolio, assess capacity, identify opportunities, and avoid redundancies; (2) help support study safety, quality, ethics, and regulatory compliance; (3) conduct evidence-based policy analysis and business process re-engineering for improved efficiency. This report summarizes how the DAIDS-ES was conceptualized, how it differs from typical clinical trial support systems, the rationale for key design choices, and examples of how it is being used to advance the efficiency and effectiveness of NIAID's HIV/AIDS clinical research programs.

Evaluating protocol lifecycle time intervals in HIV/AIDS clinical trials

“…Data were obtained from the protocol management component of the DAIDS Enterprise System (DAIDS-ES). The DAIDS-ES was launched in 2006 as a management information system modeled around a protocol lifecycle paradigm that features standardized protocol status, milestone, and event definitions [14]. Designed to harmonize protocol data elements reported by the network-specific data management centers, the DAIDS-ES provides an easily accessible, quality-assured source of specific date-based protocol tracking information from across the networks, and it enables the type of time interval analyses needed to answer the study questions.…”

Assessing the challenges of multi‐scope clinical research sites: an example from NIH HIV/AIDS clinical trials networks

“…To obtain a full listing of the CTUs and their respective CRSs, we queried the DAIDS Enterprise System (DAIDS‐ES) for information on the number of multi‐network CTUs. DAIDS‐ES is a management information system that warehouses data elements reported by the network‐specific data management centres, and it includes information on CRS locations and affiliations . At the time of data extraction, there were 42 multi‐network CTUs listed in DAIDS‐ES with 120 affiliated CRSs, including 65 single‐network CRSs and 55 multi‐network CRSs.…”

Clinical research informatics: a conceptual perspective

“…Paralleling the growth in CRI prominence, JAMIA has received an increasing number of CRI submissions. In 2010, five published articles were completely focused on CRI, 10–14 while in 2011 this number rose to 23, 15–37 accounting for 11.5% of all JAMIA articles for that year. There was a special section focused on CRI papers in the December 2011 supplement issue.…”