Abstract:
This article describes the design and results of implementation of an automated patient
registration and freatment allocation system (RETAS) used in multicenter clinical
trials. RETAS was developed using a FAX-OCR system by which handwritten Japanese and
English characters, as well as numericals and forms with check boxes, are sent from
participating institutions by Fax, processed using an optical character reader, and
then transmitted to a host computer at a statistical center. Based on the facsimile
data, RETAS can automatically review eligibility, collect patient identification data
and provide a randomized treatment allocation. RETAS permits uninterrupted, unattended
operation at a statistical center, 24 hours a day, 7 days a week. Therefore, it drastically
decreases the workload of personnel at the statistical center needed to support central
telephone registration coverage. Consequently, staff members are free to focus on
patient registration, treatment allocation, and follow-up of patients. The treatment
allocation procedure in this system is based on Pocock and Simon’s minimization method
combined with Zelen’s method for institution balancing. By this system it was possible
to balance treatment numbers for each level of various prognostic factors over an
entire trial and, at the same time, balance the allocation of treatments within an
institution. The system currently supports the protocol of a clinical trial for Adjuvant
Chemo-Endocrine Therapy for Breast Cancer in West Japan.
Keywords:
Patient Registration - Treatment Allocation - FAX-OCR System - Clinical Trial
