US 7,444,293 B1Granted

Protocol disambiguation using a model-based methodology

AssigneeFastTrack Systems, Inc.

InventorsMichael G. Kahn, Carol A. Broverman, Kelly A. Kingdon

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Abstract

Structure and methodology for reducing risk of protocol ambiguities that could lead to operational failures in the conduct of clinical trials. Roughly described, an analyst encodes the features of a protocol into a highly structured, formal model created specifically to capture issues that tend to cause operational difficulties. The process forces the analyst to look for specific parameters in the text version of the protocol. The system creates a database of the protocol as encoded, and can display the protocol schema as a graphical network of protocol events and temporal links. In one aspect, the database includes an object class into which an analyst encodes descriptions of operational uncertainties. The system can display the network in graphical-visual form, with a human-perceptible indication of objects that have operational uncertainties associated therewith. Advantageously, the formal protocol model includes slots for encoding temporal constraints among protocol events.

Claims32

Dependent claims

A method for evaluating a clinical trial protocol specification, comprising the steps of:

encoding into a database, workflow tasks called for in a clinical trial protocol specification not yet in execution, including substeps of writing, into protocol specification objects of said database, specifications of protocol events that said protocol specifies to occur during execution of said protocol, and relationships that said protocol specifies among said protocol events;
during said step of encoding workflow tasks but not during any of said substeps, identifying an operational uncertainty in which said protocol specification contains at least one of the following deficiencies:
said protocol specification fails to specify a particular parameter for use during protocol execution, or said protocol specification specifies such a parameter with less precision than is required by a slot in said database for encoding the parameter, or said protocol specification contains at least two such parameter specifications which are in conflict;
encoding into said database in association with at least a particular one of said protocol specification objects in said database, before execution of said clinical trial protocol, an indication that said operational uncertainty exists with respect to said particular object;
and
in dependence upon protocol specification objects in said database, before execution of said clinical trial protocol, displaying a graphical-visual representation of said protocol, said graphical-visual representation including a human-perceptible indication that said particular protocol specification object has said operational uncertainty associated therewith.

3 more elements

A method for evaluating a clinical trial protocol specification, comprising the steps of:

encoding into a database, workflow tasks called for in a clinical trial protocol specification not yet in execution, including substeps of writing, into protocol specification objects of said database, specifications of protocol events that the protocol specifies to occur during execution of the protocol, and relationships that the protocol specifies among said protocol events;
during said step of encoding workflow tasks but not during any of said substeps, identifying an operational uncertainty in which said protocol specification contains at least one of the following deficiencies:
said protocol specification fails to specify a parameter for use during protocol execution, or said protocol specification specifies such a parameter with less precision than is required by a slot in said database for encoding the parameter, or said protocol specification contains at least two such parameter specifications which are in conflict;
encoding into said database in association with at least a particular one of said protocol specification objects in said database, before execution of said clinical trial protocol, an indication that said operational uncertainty exists with respect to the particular protocol specification object;
and
in dependence upon objects in said database, before execution of said clinical trial protocol, outputting a report setting forth the operational uncertainties identified in said protocol and encoded into said database.

3 more elements

Dependencies are inferred from the claim text.

Facts

Application: 09/974,781Filed 10 Oct 2001 · continuation in part
Priority: 31 May 2000
Granted: 28 Oct 2008
Term ends: Not estimatedThe source records don’t support an estimate.

Classification5 codes

G16H 10/20
ICT specially adapted for the handling or processing of patient-related medical or healthcare data: for electronic clinical trials or questionnaires
G16H 70/20
ICT specially adapted for the handling or processing of medical references: relating to practices or guidelines
Y10S 707/99945
Object-oriented database structure: object-oriented database structure processing
G16H
Healthcare informatics, i.e. information and communication technology [ict] specially adapted for the