Title: Complications in using automated methods to increase clinical trial accrual

Authors: Sergiy Fefilatyev, Li Chen, Tim V. Ivanovskiy, Lawrence O. Hall, Dmitry B. Goldgof, Halina Greenstien, Christopher R. Garrett

Addresses: Computer Science and Engineering, University of South Florida, Tampa, FL 33620, USA. ' Computer Science and Engineering, University of South Florida, Tampa, FL 33620, USA. ' Computer Science and Engineering, University of South Florida, Tampa, FL 33620, USA. ' Computer Science and Engineering, University of South Florida, Tampa, FL 33620, USA. ' Computer Science and Engineering, University of South Florida, Tampa, FL 33620, USA. ' H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA. ' The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA

Abstract: This paper describes the issues involved in improving accruals for clinical trials using a web-based system. We installed a custom web-based expert system at the H. Lee Moffitt Cancer Center and Research Institute to help physicians screen patients for phase II clinical trials. The system allows physicians to screen a patient for multiple trials simultaneously. Experiments have shown that adaptation of the system into a clinical environment and the success of the system are related to the amount of time physicians are willing to spend entering data. We also found significant regulatory issues (HIPAA) that make implementation challenging.

Keywords: expert systems; clinical trials; accruals improvement; difficulties; cost; patient screening; web applications; internet; multiple trials; e-healthcare; electronic healthcare; regulatory issues; HIPAA; data inputting; patient eligibility; gastrointestinal tumours.

DOI: 10.1504/IJBET.2010.034519

International Journal of Biomedical Engineering and Technology, 2010 Vol.4 No.2, pp.134 - 150

Published online: 07 Aug 2010 *

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