IP Library › Granted Patent US 12,322,480
Granted Patent B2
US 12,322,480 · App. 17/305,372 · Granted Jun 3, 2025

Graphical study design for clinical research study systems

Inventors: Frederik Malfait (Wolfenschiessen, CH); Maurice Williams (Canton, MI); Robert Ross (Lumberton, NJ)
Assignee: Nurocor, Inc.
G16H10/20G06F3/0486G06F8/34G06F16/211G06F16/212G06F16/2246G06F16/2379G06F16/9024G06F16/9027G06F16/907G06F16/908G16H10/60
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Quick Facts
Patent No.
US 12,322,480
App. No.
17/305,372
Granted
Jun 3, 2025
Kind
B2
Abstract

Techniques are disclosed for digitizing a framework for clinical development. In one example, a computing device comprising a memory configured to store a study and a processor may be configured to perform the techniques. The processor may receive, from a user, an input specifying a plurality of trial elements for the study, and receive, from the user, an input arranging the plurality of trial elements into a tree data structure. The processor may also determine, based on the tree data structure of the plurality of trial elements, one or more trial arms for the study, each trial arm of the one or more trial arms comprising a single path between at least one trial element of the plurality of trial elements to at least one other trial element of the plurality of trial elements. The processor may further output, for display, the one or more trial arms for the study.

Claims (69)

1. A method comprising:

receiving, by processing circuitry and from a user, an input specifying a plurality of trial elements for a study;

receiving, by the processing circuitry and from the user, an input arranging the plurality of trial elements into a tree data structure;

determining, by the processing circuitry based on the tree data structure of the plurality of trial elements, two or more trial arms for the study, each trial arm of the two or more trial arms comprising a single path between at least one trial element of the plurality of trial elements to at least one other trial element of the plurality of trial elements, wherein determining, based on the tree data structure of the plurality of trial elements, the two or more trial arms for the study comprises:

deterministically traversing of the tree data structure of the plurality of trial elements to obtain one or more paths from a root of the tree data structure to a unique leaf of the tree data structure; and

defining, based on the one or more paths, the two or more trial arms for the study, each trial arm of the two or more trial arms corresponding to each path of the one or more paths; and

outputting, by the processing circuitry and for display, the two or more trial arms for the study.

2. The method of claim 1 , wherein the method further comprises: displaying, by the processing circuitry, a graphical user interface comprising:

a representation of a template area;

a plurality of representations of trial elements positioned within the template area; and

a representation of a workspace area.

3. The method of claim 2 , wherein receiving the input specifying the plurality of trial elements for the study comprises:

receiving, by the processing circuitry and from the user, an input from the user specifying movement of at least some of the plurality of the representations of trial elements from the representation of the template area to the representation of the workspace area.

4. The method of claim 3 , wherein the input from the user specifying the movement of the at least some of the plurality of the representations of trial elements from the representation of the template area to the representation of the workspace area comprises an input specifying a drag-and-drop operation to move the at least some of the plurality of the representations of trial elements from the representation of the template area to the representation of the workspace area.

5. The method of claim 2 ,

wherein each representation of the plurality of the representations of trial elements comprise at least one anchor point, and

wherein the input arranging the plurality of trial elements into the tree data structure comprises an input specifying a drag-and-drop operation to drag a connection between a first anchor point of a first representation of a first trial element of the plurality of the representations of trial elements to a second anchor point of a second representation of a second trial element of the plurality of the representations of trial elements, the input indicating a parent-child relationship of the first trial element to the second trial element.

6. The method of claim 5 ,

wherein the input specifying the plurality of trial elements for the study comprises a first input and the connection comprises a first connection,

wherein the input arranging the plurality of trail elements into the tree data structure further comprises a second input specifying the drag-and-drop operation to drag a connection between the first anchor point of the first representation of the first trail element to a third anchor point of a third representation of a third trial element,

wherein the method further comprises:

determining that the first trial element has connections to both the second trial element and the third trial element; and

refraining, responsive to determining that the first trial element has connections to both the second trial element and the third trial element, from generating the two or more trial arms until branch criteria has been specified.

7. The method of claim 1 , wherein outputting, for display, the two or more trial arms for the study comprises outputting, for display on a dashboard of a web browser, the two or more trial arms for the study.

8. The method of claim 1 , further comprising outputting, by the processing circuitry, at least one of:

a trial arm dataset for the two or more trial arms for the study; or

a trial element dataset for the two or more trial arms for the study.

9. The method of claim 1 , wherein receiving the input specifying the plurality of trial elements comprises receiving an input specifying a selection of a plurality of pre-defined trial elements for the study.

10. The method of claim 1 , wherein receiving the input specifying the plurality of trial elements comprises receiving an input defining a plurality of custom trial elements for the study.

11. The method of claim 1 , wherein the tree data structure comprises a single parent, single root tree data structure.

12. A computing device comprising:

a memory configured to store a study; and

one or more processors configured to:

receive, from a user, an input specifying a plurality of trial elements for the study;

receive, from the user, an input arranging the plurality of trial elements into a tree data structure;

determine, based on the tree data structure of the plurality of trial elements, two or more trial arms for the study, each trial arm of the two or more trial arms comprising a single path between at least one trial element of the plurality of trial elements to at least one other trial element of the plurality of trial elements, wherein to determine, based on the tree data structure of the plurality of trial elements, the two or more trial arms for the study, the one or more processors are configured to:

deterministically traverse of the tree data structure of the plurality of trial elements to obtain one or more paths from a root of the tree data structure to a unique leaf of the tree data structure; and

define, based on the one or more paths, the two or more trial arms for the study, each trial arm of the two or more trial arms corresponding to each path of the one or more paths; and

output, for display, the two or more trial arms for the study.

13. The computing device of claim 12 , where the one or more processors are further configured to display a graphical user interface comprising:

a representation of a template area;

a plurality of representations of trial elements positioned within the template area; and

a representation of a workspace area.

14. The computing device of claim 13 , wherein the one or more processors are configured, when receiving the input specifying the plurality of trial elements for the study, to:

receive, from the user, an input from the user specifying movement of at least some of the plurality of the representations of trial elements from the representation of the template area to the representation of the workspace area.

15. The computing device of claim 14 , wherein the input from the user specifying the movement of the at least some of the plurality of the representations of trial elements from the representation of the template area to the representation of the workspace area comprises an input specifying a drag-and-drop operation to move the at least some of the plurality of the representations of trial elements from the representation of the template area to the representation of the workspace area.

16. The computing device of claim 13 ,

wherein each representation of the plurality of the representations of trial elements comprise at least one anchor point, and

wherein the input arranging the plurality of trial elements into the tree data structure comprises an input specifying a drag-and-drop operation to drag a connection between a first anchor point of a first representation of a first trial element of the plurality of the representations of trial elements to a second anchor point of a second representation of a second trial element of the plurality of the representations of trial elements, the input indicating a parent-child relationship of the first trial element to the second trial element.

17. The computing device of claim 16 ,

wherein the input specifying the plurality of trial elements for the study comprises a first input and the connection comprises a first connection,

wherein the input arranging the plurality of trail elements into the tree data structure further comprises a second input specifying the drag-and-drop operation to drag a connection between the first anchor point of the first representation of the first trail element to a third anchor point of a third representation of a third trial element,

wherein the one or more processors are further configured to:

determine that the first trial element has connections to both the second trial element and the third trial element; and

refrain, responsive to determining that the first trial element has connections to both the second trial element and the third trial element, from generating the two or more trial arms until branch criteria has been specified.

18. The computing device of claim 12 , wherein the one or more processors are configured, when outputting, for display, the two or more trial arms for the study, to output, for display on a dashboard of a web browser, the two or more trial arms for the study.

19. The computing device of claim 12 , wherein the one or more processors are further configured to output at least one of:

a trial arm dataset for the two or more trial arms for the study; or

a trial element dataset for the two or more trial arms for the study.

20. The computing device of claim 12 , wherein the one or more processors are configured, when receiving the input specifying the plurality of trial elements, to receive an input specifying a selection of a plurality of pre-defined trial elements for the study.

21. The computing device of claim 12 , wherein the one or more processors are configured, when receiving the input specifying the plurality of trial elements, to receive an input defining a plurality of custom trial elements for the study.

22. The computing device of claim 12 , wherein the tree data structure comprises a single parent, single root tree data structure.

23. A non-transitory, computer-readable medium comprising instructions that, when executed, are configured to cause processing circuitry to:

receive, from a user, an input specifying a plurality of trial elements for a study;

receive, from the user, an input arranging the plurality of trial elements into a tree data structure;

determine, based on the tree data structure of the plurality of trial elements, two or more trial arms for the study, each trial arm of the two or more trial arms comprising a single path between at least one trial element of the plurality of trial elements to at least one other trial element of the plurality of trial elements, wherein to determine, based on the tree data structure of the plurality of trial elements, the two or more trial arms for the study, the instructions, when executed cause the processing circuitry to:

deterministically traverse of the tree data structure of the plurality of trial elements to obtain one or more paths from a root of the tree data structure to a unique leaf of the tree data structure; and

define, based on the one or more paths, the two or more trial arms for the study, each trial arm of the two or more trial arms corresponding to each path of the one or more paths; and

output, for display, the one or more trial arms for the study.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 10, 2021
From: MALFAIT, FREDERIK; WILLIAMS, MAURICE; ROSS, ROBERT
To: NUROCOR, INC.
Reel/Frame 058363/0155 →
Continuity (3)
Provisional Application 63198657 · Nov 2, 2020
Provisional Application 63048375 · Jul 6, 2020
Related Publication 20220005555A1 · Jan 6, 2022
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