# US 2020/0395103 A1 · Methods of performing clinical trials

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- Number: US 2020/0395103 A1
- Document ID: US20200395103A1
- Status: Published application
- Kind: A1
- Application number: 16/971,500
- Filed: 2019-02-20
- Published: 2020-12-17
- Earliest claimed: 2018-02-21
- Assignees: Klaritos, Inc.
- Applicants: Klaritos, Inc.
- Inventors: Vijay RAMAKRISHNAN; Edwin P. CHING
- Web page: https://patentgrep.com/patent/US20200395103A1

## CPC

- G16H 10/20: for electronic clinical trials or questionnaires
- G06F 16/31: Indexing; Data structures therefor; Storage structures
- Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Disclosed herein are methods of performing clinical trials. Also disclosed herein are methods of obtaining payments for a medicament. Also disclosed herein are systems and devices for selecting a medicament for a subject.

## Claims

### Claim at position 1

1-135. (canceled)

### Claim 136

A clinical trial testing a drug, wherein said trial can be funded at least in part by a third-party payer, which may be a healthcare payer or insurer, and wherein said trial may not be substantially funded by a pharmaceutical company that developed and/or commercialized said drug.

### Claim 137 (depends on 136)

The trial of claim 136, wherein said trial comprising a sizeable number of subjects, wherein said subjects may pay to participate in the trial.

### Claim 138 (depends on 137)

The trial of claim 137, wherein said trial:
a) can be of substantial size, wherein at least a sizeable number of said subjects may directly pay-to-participate, or indirectly pay-to-participate, e.g., through an insurer or other payer;
b) can be a single-site trial, or can be a virtual-site trial; and/or
c) can include at least some subjects who are provided assurance, which may be a therapeutic and/or financial assurance.

### Claim 139 (depends on 137)

The trial of claim 137, wherein said trial:
a) can be funded, wholly or at least in part, by a third-party payer, such as a private payer, government payer, pension fund, employer, or managed care company, but may not be substantially funded by a pharmaceutical company that developed and/or commercialized said drug;
b) can be large, such as thousands or tens of thousands of subjects;
c) can be conducted for a substantial period, such as at least about 4, 6, 7, 8, 9, or more years;
d) can be a phase-4 clinical trial; and/or
e) can be for testing a drug or equivalent listed in table 1, 2, or 3.

### Claim 140

A method of conducting a clinical trial of substantial size, wherein at least a sizeable number of subjects may enroll on a pay-to-participate basis.

### Claim 141 (depends on 140)

The method of claim 140, wherein said sizeable number of subjects may pay-to-participate either directly or their cost can be borne wholly or at least in part by a third-party payer.

### Claim 142 (depends on 140)

The method of claim 140, wherein said trial:
a) can be a single-site trial, or can be a virtual-site trial;
b) can include at least some subjects who are provided assurance, which can be a therapeutic and/or financial assurance;
c) can be conducted, wholly or at least in part, by a third-party sponsor, such as a managed care company or a fully-integrated payer having managed care capabilities, but may not be funded by a pharmaceutical company that developed and/or commercialized the drug that is being tested;
d) can be large, such as thousands or tens of thousands of subjects;
e) can be conducted for a substantial period, such as at least about 4, 6, 7, 8, 9, or more years;
f) can be a phase-4 clinical trial; and/or
g) can be for testing a drug or equivalent which is listed in table 1, 2, or 3.

### Claim 143

A clinical trial testing a drug, wherein said trial can be conducted by a third-party sponsor, and said third-party sponsor cannot be a pharmaceutical company that developed, and/or commercialized said drug.

### Claim 144 (depends on 143)

The trial of claim 143, wherein said trial:
a) conducted by a third-party sponsor can be a managed care company;
b) can be a single-site trial, or can be a virtual-site trial; or
c) can include at least some subjects who are provided assurance, which can be a therapeutic and/or financial assurance.

### Claim 145 (depends on 144)

The trial of claim 144, wherein said trial:
a) can be funded, wholly or at least in part, by a payer, an employer, or managed care company, or wholly or in part by pay-to-participate subjects, whose payments can cover full or partial drug and/or participation costs;
b) can be sizeable, such as thousands or tens of thousands of subjects;
c) can be conducted for a substantial period, such as at least about 4, 6, 7, 8, 9, or more years;
d) can be a phase-4 clinical trial; and/or
e) can be for testing a drug or equivalent which is listed in table 1, 2, or 3.

### Claim 146

A method of conducting a clinical trial by a third-party sponsor.

### Claim 147 (depends on 146)

The method of claim 146, wherein said trial:
a) conducted by a third-party sponsor can be a managed care company, or a healthcare payer having managed care capabilities;
b) said trial can be a single-site trial, or can be a virtual-site trial; and/or
c) said trial can include at least some subjects who are provided assurance, which can be a therapeutic and/or financial assurance.

### Claim 148 (depends on 146)

The method of claim 146, wherein said trial:
a) either can be funded, wholly or at least in part, by pay-to-participate subjects whose payments can cover full or partial drug and/or participation costs; or may be paid, wholly or at least in part, by a payer such as an insurer, employer, or a managed care company;
b) can be sizeable, such as thousands or tens of thousands of subjects;
c) can be conducted for a substantial period, such as at least about 4, 6, 7, 8, 9, or more years;
d) can be a phase-4 clinical trial; and/or
e) can be for testing a drug or equivalent which is listed in table 1, 2, or 3.

### Claim 149

A method of gaining exemption from infringement of a national patent with claims covering a patented technology, which can comprise using a patented technology solely for uses reasonably related to the development or submission of information under a Federal law which regulates the manufacture, use, offers to sell, or sale of drugs.

### Claim 150 (depends on 149)

The method of claim 149, wherein the uses reasonably related to the development or submission of information under a Federal law which regulates the manufacture, use, offers to sell, or sale of drugs can be a clinical trial.

### Claim 151 (depends on 149)

The method of claim 149, wherein said national patent can be issued in the US, Europe, UK, Germany, France, Spain, Italy, Sweden, Canada, Mexico, Japan, China, South Korea, or India.

### Claim 152 (depends on 150)

The method of claim 150, wherein said trial:
a) can be a single-site trial, or can be a virtual-site trial;
b) can include at least some subjects who are provided assurance, which can be a therapeutic and/or financial assurance;
c) can be funded, wholly or at least in part, by a third-party payer, an employer, or a managed care company; or can include pay-to-participate subjects whose payments can cover full or partial drug and/or participation costs;
d) can be conducted by a third-party sponsor;
e) can be sizeable, such as thousands or tens of thousands of subjects;
f) can be conducted for a substantial period, such as at least about 4, 6, 7, 8, 9, or more years;
g) can be a phase-4 clinical trial; and/or
h) can be for testing a drug or equivalent which is listed in table 1, 2, or 3.

### Claim 153

A method of administering a drug to patients in a clinical trial, wherein said drug is covered by market exclusivity.

### Claim 154 (depends on 153)

The method of claim 153, wherein the market exclusivity exists in the US, Europe, EP, UK, Germany, France, Spain, Italy, Sweden, Canada, Mexico, Japan, China, South Korea, or India.

### Claim 155 (depends on 153)

The method of claim 153, wherein said trial:
a) is funded, wholly or at least in part, by a third-party payer, an employer, or a managed care company; or includes pay-to-participate subjects whose payments cover full or partial drug and/or participation costs;
b) is conducted by a third-party sponsor;
c) is sizeable, such as hundreds or thousands or tens of thousands of subjects;
d) is conducted for a substantial period, such as at least about 4, 6, 7, 8, 9, or more years;
e) is a single-site trial, or is a virtual-site trial;
f) includes at least some subjects who are provided assurance, which is a therapeutic and/or financial assurance;
g) is a phase-2 or -3 clinical trial; and/or
h) is testing a drug or equivalent which is listed in table 1, 2, or 3.