# US 2021/0240883 A1 · Multi-space trial design platform

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- Number: US 2021/0240883 A1
- Document ID: US20210240883A1
- Status: Published application
- Kind: A1
- Application number: 17/163,424
- Filed: 2021-01-30
- Published: 2021-08-05
- Earliest claimed: 2020-01-31
- Applicants: Cytel Inc.
- Inventors: Jaydeep Bhattacharya; James Bolognese; Alexandre Buer; Eric Edwards; Stanley Y. Huang; Yannis Jemiai; Cyrus Mehta; Nitin Patel; Anne Pelz; Ajay Prabhakar Sathe; Joshua A. Schultz; Pralay Senchaudhuri
- Web page: https://patentgrep.com/patent/US20210240883A1

## CPC

- G16H 10/20: for electronic clinical trials or questionnaires
- G06F 30/10: Geometric CAD
- G06F 30/12: characterised by design entry means specially adapted for CAD, e.g. graphical user interfaces [GUI] specially adapted for CAD
- G06F 30/20: Design optimisation, verification or simulation (optimisation, verification or simulation of circuit designs G06F30/30)
- G06F 30/27: using machine learning, e.g. artificial intelligence, neural networks, support vector machines [SVM] or training a model
- G06N 3/08: Learning methods
- G06N 3/09: Supervised learning
- G06N 5/01: Dynamic search techniques; Heuristics; Dynamic trees; Branch-and-bound
- G06N 5/04: Inference or reasoning models
- G06N 7/01: Probabilistic graphical models, e.g. probabilistic networks
- G06N 20/00: Machine learning
- G06Q 10/06315: {Needs-based resource requirements planning or analysis}
- G06Q 10/067: Enterprise or organisation modelling
- G06Q 10/0674: {using process simulation}
- G06Q 10/101: Collaborative creation, e.g. joint development of products or services
- G06Q 30/0205: {based on location or geographical consideration}
- G16H 40/20: for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
- G16H 40/67: for remote operation
- G16H 50/50: for simulation or modelling of medical disorders
- G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients
- G06F 3/0484: for the control of specific functions or operations, e.g. selecting or manipulating an object, an image or a displayed text element, setting a parameter value or selecting a range
- G06F 2111/02: CAD in a network environment, e.g. collaborative CAD or distributed simulation
- G06F 2111/04: Constraint-based CAD
- G06F 2111/06: Multi-objective optimisation, e.g. Pareto optimisation using simulated annealing [SA], ant colony algorithms or genetic algorithms [GA]
- G06F 2111/08: Probabilistic or stochastic CAD
- G06F 2111/16: Customisation or personalisation
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- G06N: COMPUTING ARRANGEMENTS BASED ON SPECIFIC COMPUTATIONAL MODELS
- G06Q: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR

## Abstract

A method, according to some implementations, includes obtaining a criteria for a trial design study, determining permutations for designs in response to the criteria, and determining permutations for scenarios in response to the criteria. The method may further include generating combinations of the permutations for the designs and the permutations for the scenarios, simulating designs corresponding to the generated combinations, and determining performance of the simulated designs.

## Claims

### Claim at position 1

-595. (canceled)

### Claim 596

A method comprising:
obtaining a criteria for a trial design study;
determining permutations for designs in response to the criteria;
determining permutations for scenarios in response to the criteria;
generating combinations of the permutations for the designs and the permutations for the scenarios;
simulating designs corresponding to the generated combinations; and
determining performance of the simulated designs.

### Claim 597 (depends on 596)

The method of claim 596 further comprising:
estimating a number of the combinations using the criteria.

### Claim 598 (depends on 597)

The method of claim 597 further comprising:
in response to the estimated number being greater than a threshold, suggesting modifications to the criteria.

### Claim 599 (depends on 597)

The method of claim 597 further comprising:
in response to the estimated number being less than a threshold, suggesting modifications to the criteria.

### Claim 600 (depends on 596)

The method of claim 596 further comprising:
examining the combinations for invalid combinations.

### Claim 601 (depends on 596)

The method of claim 596 further comprising:
examining the permutations for invalid permutations.

### Claim 602 (depends on 596)

The method of claim 596 further comprising:
predicting the performance of the combinations; and
removing a subset of the combinations, prior to simulating the designs, based on the predicted performance.

### Claim 603 (depends on 602)

The method of claim 602, wherein the predicting is based on historical data.

### Claim 604 (depends on 596)

The method of claim 596, wherein the combinations are exhaustive for the criteria.

### Claim 605 (depends on 596)

The method of claim 596 further comprising:
determining optimality from the performance of the simulated designs.

### Claim 606

An apparatus comprising:
a space definition circuit structured to interpret criteria data for a trial design;
a design parameter circuit structured to determine permutations for designs in response to the criteria data;
a scenario parameter circuit structured to determine permutations for scenarios in response to the criteria data;
a combinations circuit structured to generate combinations of permutations for designs and permutations for scenarios; and
a simulation circuit structured to evaluate a performance of each combination.

### Claim 607 (depends on 606)

The apparatus of claim 606 further comprising:
an estimator circuit configured to estimate number of combinations using the criteria.

### Claim 608 (depends on 606)

The apparatus of claim 606 further comprising:
a validity checker circuit configured to examine the combinations for invalid combinations.

### Claim 609 (depends on 606)

The apparatus of claim 606 further comprising:
a validity checker circuit configured to examine the permutations for invalid permutations.

### Claim 610 (depends on 606)

The apparatus of claim 606 further comprising:
a validity checker circuit configured to:
predict the performance of the combinations; and
remove a subset of the combinations prior to simulating based on the predicted performance.

### Claim 611 (depends on 610)

The apparatus of claim 610, wherein the performance is predicted based on historical data.

### Claim 612 (depends on 606)

The apparatus of claim 606, wherein the combinations of permutations are exhaustive for the criteria.

### Claim 613 (depends on 606)

The apparatus of claim 606, further comprising an analysis circuit configured to determine optimality from the performance.

### Claim 614

A method comprising:
configuring an execution flow for a trial design evaluation using a configurable interface having at least one node element and at least one arc element, wherein the execution flow is defined, in part, via the at least one node element and the at least one arc element;
executing the trial design evaluation using the execution flow;
reconfiguring at least one of the at least one node element or the at least one arc element in the execution flow; and
executing the trial design evaluation using the reconfigured execution flow.

### Claim 615 (depends on 614)

The method of claim 614, 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 executing the trial design evaluation 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 results from the execution of the trial design evaluation based at least in part on a relationship between the results and supplemental data;
generating a performance surface based at least in part on a set of trial designs corresponding to the results;
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 results from the execution of the trial design evaluation.

### Claim at position 22

-696. (canceled)