Granted Patent B2

US 12,322,479 · App. 17/163,423 · Granted Jun 3, 2025

Inventors: Jaydeep Bhattacharyya (Acton, MA); James Bolognese (Woodbridge, NJ); Alexandre Buer (Holliston, MA); Eric Edwards (Nolensville, TN); Stanley Y. Huang (Wellesley, MA); Yannis Jemiai (Lexington, MA); Cyrus Mehta (Cambridge, MA); Nitin Patel (Cambridge, MA); Anne Pelz (Arlington, MA); Ajay Prabhakar Sathe (Pune, IN); Joshua A. Schultz (Boston, MA); Pralay Senchaudhuri (Cambridge, MA)

Assignee: Cytel Inc.

G16H10/20G06F30/10G06F30/12G06F30/20G06N5/04G06N20/00G06Q10/06315G06Q10/067G06Q30/0205G16H40/20G16H50/70G06F2111/02G06F2111/04G06F2111/06G06F2111/08G06F2111/16

Abstract

Claims (47)

1. A method for determining trial designs, the method comprising:

obtaining, via at least one processor, simulation data for a set of trial designs that includes all combinations of design options for a set of criteria, wherein the simulation data includes performance parameters and performance parameter values associated with each design in the set of trial designs for the set of criteria;

determining, via the at least one processor, an optimality criteria for evaluating the trial designs, wherein the optimality criteria includes Pareto optimality and convex hull optimality for clinical trial design performance values;

determining, via the at least one processor and based at least in part on the simulation data, a cooling cycle, a parameter change, and a direction;

searching, via the at least one processor and within the set of trial designs, for a set of globally optimum designs based on the optimality criteria using simulated annealing, wherein the simulated annealing is based at least in part on the cooling cycle, the parameter change, and the direction; and

recommending, via the at least one processor, the set of globally optimum designs to a user via a user interface.

2. The method of claim 1 , wherein the optimality criteria is based on historical data and includes performance parameters of a benchmark design.

3. The method of claim 1 , wherein the optimality criteria is based on a weighted sum of performance criteria values of each of the set of trial designs.

4. The method of claim 1 , further comprising:

changing the optimality criteria based on a number of globally optimum designs.

5. The method of claim 1 , further comprising:

determining a second optimality criteria; and

searching, within the set of trial designs, for a second set of globally optimum designs based on the second optimality criteria.

6. The method of claim 1 , further comprising:

determining a second optimality criteria; and

searching, within the set of globally optimum designs, for a second set of globally optimum designs based on the second optimality criteria.

7. The method of claim 1 , further comprising:

dynamically changing the optimality criteria in response to properties of globally optimum designs.

8. The method of claim 1 , further comprising:

dynamically changing the optimality criteria in response to user feedback.

9. The method of claim 1 , further comprising:

evaluating historical trial design selections to identify one or more trial design parameters based at least in part on one or more trial design criteria determined from a user via an interactive interface, wherein obtaining the simulation data is based at least in part on a quick search data structure and the one or more trial design parameters;

generating a substitute for at least some of the simulation data based at least in part on a relationship between the simulation data and supplemental data;

generating a performance surface based at least in part on the set of trial designs;

evaluating one or more trial designs based at least in part on the performance surface; and

calculating a score based on normalized score component values corresponding to the simulation data.

10. An apparatus comprising:

a data processing circuit configured to obtain design data for a set of trial designs that includes all combinations of design options for a set of criteria;

an optimality determining circuit configured to:

determine an optimality criteria for evaluating the set of trial designs, wherein the optimality criteria includes Pareto optimality and convex hull optimality for clinical trial design performance values;

determine, based at least in part on the design data, a cooling cycle, a parameter change, and a direction; and

search, from the set of trial designs, for globally optimum designs based on the optimality criteria using simulated annealing, wherein the simulated annealing is based at least in part on the cooling cycle, the parameter change, and the direction; and

a design analysis circuit configured to:

analyze the globally optimum designs;

determine a modification to the optimality criteria; and

present the modification to a user via a user interface;

wherein the optimality determining circuit is structured to receive the modification and determine a second set of globally optimum designs.

11. The apparatus of claim 10 , wherein the optimality criteria is based on historical data and includes performance parameters of a benchmark design.

12. The apparatus of claim 10 , wherein the optimality criteria is based on a weighted sum of performance criteria values of each of the set of trial designs.

13. The apparatus of claim 10 , wherein the modification is based on a number of globally optimum designs.

14. The apparatus of claim 10 , wherein the modification is in response to user feedback.

15. A non-transitory computer-readable medium storing instructions that adapt at least one processor to:

obtain a simulation data for a set of trial designs that includes all combinations of design options for a set of criteria, wherein the simulation data includes performance parameters and performance parameter values associated with each design in the set of trial designs for the set of criteria;

determine an optimality criteria for evaluating the set of trial designs, wherein the optimality criteria includes Pareto optimality and convex hull optimality for clinical trial design performance values;

determine, based at least in part on the simulation data, a cooling cycle, a parameter change, and a direction;

search, within the set of trial designs, for globally optimum designs based on the optimality criteria using simulated annealing, wherein the simulated annealing is based at least in part on the cooling cycle, the parameter change, and the direction; and

recommend the globally optimum designs to a user via a user interface.

Assignments (3)

Continuity (7)

References Cited (129)