DR. MICHAEL GARY KAHN, M.D.
Osteopathic Medicine at Greenbriar Blvd, Boulder, CO

8571891, Oct 29, 2013

Apr 29, 2013

13/872460

Peter Leonard Abramowitsch - Fairfax CA, US
Michael Gary Kahn - Boulder CO, US
Christopher Noon - Thursley, GB

Medidata Solutions, Inc. - New York NY

G06Q 10/00

705 2, 705 3

Roughly described, a user instantiates protocol elements in a structured clinical trial protocol database and then draws from them in the development of one or more protocol related documents. The system helps the user select tasks to be performed during the study by reference to a historical database of tasks previously associated with similar protocols. The system automatically generates complex content from protocol elements in the database, and can render overlapping sets of protocol elements differently at different locations in the document. The system can automatically provide advisories indicating aspects of the document that still require completion or highlighting other issues that a sponsoring authority deems important for the document type. After all protocol elements are instantiated in the protocol database, it can then be used to drive the operation of most downstream aspects of the study.

2014003, Feb 6, 2014

Oct 15, 2013

14/054269

Michael Gary Kahn - Boulder CO, US
Christopher Noon - Thursley, GB
Peter Leonard Abramowitsch - Fairfax CA, US

MEDIDATA SOLUTIONS, INC. - New York NY

G06F 19/00

705 2

Roughly described, a user instantiates protocol elements in a structured clinical trial protocol database and then draws from them in the development of one or more protocol related documents. The system helps the user select tasks to be performed during the study by reference to a historical database of tasks previously associated with similar protocols. The system automatically generates complex content from protocol elements in the database, and can render overlapping sets of protocol elements differently at different locations in the document. The system can automatically provide advisories indicating aspects of the document that still require completion or highlighting other issues that a sponsoring authority deems important for the document type. After all protocol elements are instantiated in the protocol database, it can then be used to drive the operation of most downstream aspects of the study.

8504380, Aug 6, 2013

Jun 5, 2003

10/454954

Carol A. Broverman - Menlo Park CA, US
Michael G. Kahn - Boulder CO, US
Christopher Noon - Dublin CA, US

Medidata Solutions, Inc. - New York NY

G06Q 10/00

705 2, 705 3

Roughly described, a user instantiates protocol elements in a structured clinical trial protocol database and then draws from them in the development of one or more protocol related documents. The system helps the user select tasks to be performed during the study by reference to a historical database of tasks previously associated with similar protocols. The system automatically generates complex content from protocol elements in the database, and can render overlapping sets of protocol elements differently at different locations in the document. The system can automatically provide advisories indicating aspects of the document that still require completion or highlighting other issues that a sponsoring authority deems important for the document type. Alter all protocol elements are instantiated in the protocol database, it can then be used to drive the operation of most downstream aspects of the study.

2003006, Apr 3, 2003

Oct 3, 2001

09/970182

Michael Kahn - Boulder CO, US
Michael Mischke-Reeds - San Francisco CA, US
John Nguyen - San Jose CA, US

FastTrack Systems, Inc.

G06F007/00

707/100000

Roughly described, a machine-readable protocol database identifies a sequence of workflow tasks for a clinical trial protocol. The sequence of workflow tasks is organized as a graph whose nodes can contain or represent patient contact event objects, with one or more of the tasks assigned to each patient contact event object. The graph also indicates preferred or expected times for a patient to transition from one node to the next, and optionally also indicates a predicted likelihood that different alternative paths will be taken to a common destination node. A problem-solving method automatically extracts the time duration expected or predicted for a patient to traverse each separate phase of the protocol. Such durations are provided to a simulation engine which automatically generates timeline forecasts of patient progress through at least part of the workflow tasks prescribed by the protocol.

7444293, Oct 28, 2008

Oct 10, 2001

09/974781

Michael G. Kahn - Boulder CO, US
Carol A. Broverman - Menlo Park CA, US
Kelly A. Kingdon - San Rafael CA, US

FastTrack Systems, Inc. - San Mateo CA

G06Q 50/00

705 3, 705 2, 707100, 7071041, 717135, 600300, 704 9

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.

2002004, Apr 4, 2002

Mar 22, 2001

09/816649

Thomas Bailey - Kirkwood MO, US
Laura Noirot - St. Louis MO, US
Michael Kahn - Boulder CO, US
Sherry Steib - St. Louis MO, US

G06F015/00

702/188000

A clinical decision support application screens drug orders for drug dosing errors based on patient-specific information. The support application verifies that medication dosages are appropriately adjusted for renal function based upon calculated creatinine clearance (CrCI). In addition to looking for overdosing errors, other important features are its ability to detect under-dosing, and dosages and intervals that are not consistent with institution policy. The clinical decision support application also detects potentially dangerous drug combinations and serves as a safety net by providing a drug-drug interaction alert to a healthcare professional as well as reminders and escalations. Alert reports contain patient demographic data, the dose and start date of the interacting medications, pertinent laboratory or drug data, an educational comment with a recommendation for alternative therapy, and a customized outcome section that includes expected adverse events and treatment options for the detected interaction.

8533008, Sep 10, 2013

Jul 20, 2009

12/505860

Michael G. Kahn - Boulder CO, US
Michael Mischke-Reeds - San Francisco CA, US

Medidata Solutions, Inc. - New York NY

G06Q 50/00

705 3, 705 2, 705 727

Meta-models are made available to clinical trial protocol designers. A meta-model includes a list of preliminary patient eligibility attributes appropriate for a particular disease category. The protocol designer chooses the appropriate meta-model, and encodes the clinical trial protocol, including eligibility and patient workflow, within the selected meta-model in a protocol database. The resulting protocol database is stored together with databases of other protocols in a library of protocol databases. Sponsors and individual clinical sites have controlled access to the protocols. Study sites make reference to the protocol database in order to perform patient eligibility screening. Once a patient is enrolled into a study, the protocol database indicates to the clinician what workflow tasks are to be performed at each patient visit.