Northwestern Oncology Trial Information System (NOTIS) (22042)

The NORTHWESTERN Oncology Trial Information System (NOTIS) is a web-enabled database that was developed to comprehensively capture data generated by cancer clinical trials. Unlike state-of-the-art clinical software solutions, NOTIS is event-driven rather than time-driven – a fundamental feature that makes it ideal for oncology trials. However, NOTIS can be applied to areas outside of oncology and of medicine in general.

As concerns a clinical trial application, an experimental protocol used in conjunction with NOTIS is comprised of different stages that may, at least to some extent, overlap:

1. Protocol Development 2. Patient Recruitment 3. Patient Screening and Registration 4. Protocol Implementation 5. Analysis and Publication

NOTIS is easy to adapt to the business rules of a particular implementation. NOTIS is based upon a three-tiered ‘e-commerce’ architecture. This consists of a database layer or “back end” (Oracle), a “middleware” web-server layer (Macromedia Cold Fusion), and the web-client (e.g. Netscape or Internet Explorer).

The “business rules” (the application logic) of NOTIS appertain to the implementation of the experimental protocols, such as the scheduling of a certain drug after a diagnostic event has occurred. NOTIS implements such business rules in Cold Fusion Markup Language. This allows the customization of business rules for an interface specific to a certain group of users (clinicians, Labs, etc.) while still allowing the customized interface to reference the same underlying unified data set referenced by the other interfaces.

NOTIS also employs a novel method of keeping patient records anonymous while preserving the relation of a patient record to associated experimental data (e.g. genetic profile).

STATE OF IMPLEMENTATION: NOTIS currently houses patient information on more than 30,000 patients from multiple affiliates, and is used daily by more the 30 coordinators working on 250 open clinical trials

Inventor(s): Andrew Winter and Warren Kibbe

Type of Offer: Licensing



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