title: OnWARD: ontology-driven web-based framework for multi-center clinical studies.
abstract: With a large percentage of clinical trials still using paper forms as the primary data collection tool, there is much potential for increasing efficiency through web-based data collection systems, especially for large-scale multi-center trials. This paper presents OnWARD, an ontology-driven, secure, rapidly-deployed, web-based framework supporting data capture for large-scale multi-center clinical research. Our approach is developed using the agile methodology to provide a flexible, user-centered dynamic form generator, which can be quickly deployed and customized for any clinical study without the need of deep technical expertise. Because of the flexible framework, the data management system can be extended to accommodate a large variety of data types, including genetic, genomic and proteomic data. In this paper, we demonstrate the initial deployment of OnWARD for a Phase II multi-center clinical trial after a development period of merely three months. The study utilizes 23 clinical report forms containing more than 1500 data points. Preliminary evaluation results show that OnWARD exceeded expectations of the clinical investigators in efficiency, flexibility and ease in setting up.
authors.affiliation: Department of Electrical Engineering and Computer Science, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH 44106, USA.
authors.forename: Van-Anh
authors.initials: VA
authors.lastname: Tran
authors.affiliation: Center for Clinical Investigation, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH 44106, USA.
authors.forename: Nathan
authors.initials: N
authors.lastname: Johnson
authors.affiliation: Center for Clinical Investigation, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH 44106, USA; Department of Medicine, Division of Sleep Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Redline
authors.affiliation: Department of Electrical Engineering and Computer Science, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH 44106, USA; Center for Clinical Investigation, Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH 44106, USA. Electronic address: gq@case.edu.
authors.forename: Guo-Qiang
authors.initials: GQ
authors.lastname: Zhang
mesh_terms: D035843:Biomedical Research / Q000379:methods; D002985:Clinical Protocols; D017322:Clinical Trials, Phase II as Topic; D006801:Humans; D020407:Internet; D015337:Multicenter Studies as Topic; D012984:Software