OncoWorkstation - A Software Tool for the Planning and Realization of Clinical Trials

Motivation

Randomized, controlled trials are an essential instrument for ensuring treatment quality in oncological care. These trials are based on trial protocols, which reflect a certain standard of treatment. The use and access to these protocols, however, is not regulated in a uniform manner. Moreover, the non-standard format and varied degree of detail of protocols render comparison and the selection of a suitable, patient-specific protocol quite difficult. Beyond this, there are no software systems available on the market which adequately support the protocol-compliant planning of clinical therapy.

Objective

The objective of the OncoWorkstation project is the computer-based delivery of trial-relevant, standardized information to improve the quality and efficiency of tumor patient treatment. For this purpose, an internet-based software system was developed comprising standardized oncological trial protocols, therapy schemata and a therapy planning component.

Methods and Implementation

The system was realized on the basis of widely used standards (XSLT/XML/SQL) such as Java Servlet. An application module as well an author module are available for evaluation at the following internet address http://www.oncoworkstation.de/ows/home. Hitherto the Competence Network Malignant Lymphomas has introduced 14 updated short trial protocols (as of May 2004). The doctor is supported in the daily aspects of protocol-based therapy planning through the standardized information format of these protocols in the OncoWorkstation. In addition to the presentation of the protocol contents on the screen there is a standardized print format for each protocol and a uniform therapy flowsheet format.

60 Therapy schemata from trial protocols as well as professional literature are available in a standardized form in the tool (as of June 2004). These are extendable through clinic-specific and protocol-specific requirements (e.g. supplementary treatments).

Patient-oriented, individual therapy planning with the option of dosage modification and supplemental treatments is available for local installations of the therapy planning module.

Evaluation

Short trial protocols are evaluated together with the relevant trial groups. The practice trial of the therapy planning module will take place first at the St. Georg Municipal Clinic in Leipzig and later with the medical partners of the Competence Network Malignant Lymphomas and the Competence Network Pediatric Oncology and Hematology.

Further Development

Following the evaluation phase at St. Georg Municipal Clinic in Leipzig the tool will be expanded with new protocols and therapy schemata and an organizational structure for permanent operation. With respect to contents, an interface to a uniform, semantically founded term base will be defined and further interfaces to clinical information systems (HL7), internet-based (tumor and/or trial) registers and trial documentation support will be developed.

Project team: Michael Brosig Frank Meineke Roman Mishchenko Dr. Luisa Mantovani, Renate Abelius (St. Georg Municipal Clinic, Leipzig) Project management: Prof. Markus Löffler

Contact address:   IMISE Universität Leipzig Härtelstraße 16-18 04107 Leipzig Phone: +49 341 97-16183 Fax: +49 341 97-16130 E-mail: E-Mail-Adresse