Rep. Monica Bristow

Adopted in House Comm. on Oct 28, 2019

 

 


 

 


 
10100SB1711ham001LRB101 09730 RPS 64116 a

1
AMENDMENT TO SENATE BILL 1711

2    AMENDMENT NO. ______. Amend Senate Bill 1711 by replacing
3everything after the enacting clause with the following:
 
4    "Section 1. Short title. This Act may be cited as the
5Cancer Clinical Trial Participation Program Act.
 
6    Section 5. Findings. The General Assembly finds that:
7        (1) The ability to translate medical findings from
8    research to practice relies largely on robust subject
9    participation and a diverse subject participation pool in
10    clinical trials.
11        (2) Diverse subject participation in cancer clinical
12    trials depends significantly on whether an individual is
13    able to afford ancillary costs, including transportation
14    and lodging, during the course of participation in a cancer
15    clinical trial.
16        (3) A national study conducted in 2015 found that

 

 

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1    individuals from households with an annual income of less
2    than $50,000 were 30% less likely to participate in cancer
3    clinical trials.
4        (4) Direct and indirect costs, including
5    transportation, lodging, and child-care expenses, prevent
6    eligible individuals from participating in cancer clinical
7    trials according to the National Cancer Institute.
8        (5) The disparities in subject participation in cancer
9    clinical trials threaten the basic ethical underpinning of
10    clinical research, which requires the benefits of the
11    research to be made available equitably among all eligible
12    individuals.
13        (6) While the United States Food and Drug
14    Administration recently confirmed to Congress and provided
15    guidance on its website that reimbursement of direct
16    subject-incurred expenses is not an undue inducement, many
17    organizations, research sponsors, philanthropic
18    individuals, charitable organizations, governmental
19    entities, and other persons still operate under the
20    misconception that such reimbursement is an undue
21    inducement.
22        (7) It is the intent of the General Assembly to enact
23    legislation to further define and establish a clear
24    difference between items considered to be an undue
25    inducement for a subject to participate in a cancer
26    clinical trial and the reimbursement of expenses for

 

 

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1    participating in a cancer clinical trial.
2        (8) Further clarification of the United States Food and
3    Drug Administration's confirmation and guidance is
4    appropriate and important to improve subject participation
5    in cancer clinical trials, which is the primary intent of
6    this legislation.
 
7    Section 10. Definitions. In this Act:
8    "Cancer clinical trial" means a research study that
9subjects an individual to a new cancer treatment, including a
10medication, chemotherapy, adult stem cell therapy, or other
11treatment.
12    "Cancer clinical trial sponsor" means a person, physician,
13professor, or researcher who initiates a cancer clinical trial;
14a government entity or agency that initiates a cancer clinical
15trial; or an industry, including, but not limited to, a
16pharmaceutical, biotechnology, or medical device company, that
17initiates a cancer clinical trial.
18    "Independent third-party organization" means an entity or
19organization, whether public or private, that is not a sponsor
20or host of a cancer clinical trial, or in any way directly
21affiliated with a sponsor or host of a cancer clinical trial,
22and has experience in patient advocacy and direct patient
23reimbursement of cancer clinical trial participation costs.
24    "Inducement" means providing a person something of value,
25including money, as part of participation in a clinical trial.

 

 

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1    "Program" means the cancer clinical trial participation
2program established under this Act.
3    "Subject" means an individual who participates in the
4program.
5    "Undue inducement" means the value of something received by
6a potential clinical trial research subject, which value is so
7large that it causes the research subject to take risks that
8are not in his or her best interests.
 
9    Section 15. Establishment. An independent third-party
10organization may develop and implement the cancer clinical
11trial participation program to provide reimbursement to
12subjects for ancillary costs associated with participation in a
13cancer clinical trial, including costs for:
14        (1) travel;
15        (2) lodging;
16        (3) parking and tolls; and
17        (4) other costs considered appropriate by the
18    organization.
 
19    Section 20. Requirements; notice.
20    (a) The program:
21        (1) must collaborate with physicians, health care
22    providers, and cancer clinical trial sponsors to notify a
23    prospective subject about the program when:
24            (A) the prospective subject consents to a cancer

 

 

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1        clinical trial; or
2            (B) funding is available to provide the program for
3        the cancer clinical trial in which the prospective
4        subject participates;
5        (2) must reimburse subjects based on financial need,
6    which may include reimbursement to subjects whose income is
7    at or below 700% of the federal poverty level;
8        (3) must provide reimbursement for ancillary costs,
9    including costs described under Section 15, to eliminate
10    the financial barriers to enrollment in a cancer clinical
11    trial;
12        (4) may provide reimbursement for reasonable ancillary
13    costs, including costs described under Section 15, to one
14    family member, friend, or other person who attends a cancer
15    clinical trial to support a subject; and
16        (5) must comply with applicable federal and State laws.
17    (b) The independent third-party organization administering
18the program shall provide written notice to prospective
19subjects of the requirements described under subsection (a).
 
20    Section 25. Reimbursement requirements; notice.
21    (a) A reimbursement under the program at a trial site that
22conducts cancer clinical trials must:
23        (1) be reviewed and approved by the institutional
24    review board associated with the cancer clinical trial for
25    which the reimbursement is provided; and

 

 

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1        (2) comply with applicable federal and State laws.
2    (b) The independent third-party organization operating the
3program is not required to obtain approval from an
4institutional review board on the financial eligibility of a
5subject who is medically eligible for a cancer clinical trial.
6    (c) The independent third-party organization operating the
7program shall provide written notice to a subject on:
8        (1) the nature and availability of the ancillary
9    financial support under the program; and
10        (2) the program's general guidelines on financial
11    eligibility.
 
12    Section 30. Reimbursement status as undue inducement.
13Reimbursement to a subject of ancillary costs under the
14program:
15        (1) does not constitute an undue inducement to
16    participate in a cancer clinical trial;
17        (2) is not considered coercion or the exertion of undue
18    influence to participate in a cancer clinical trial; and
19        (3) is meant to accomplish parity in access to cancer
20    clinical trials and remove barriers to participation in
21    cancer clinical trials for financially burdened subjects.
 
22    Section 35. Funding. The independent third-party
23organization that administers the program may accept gifts,
24grants, and donations from any public or private source to

 

 

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1implement this Act.
 
2    Section 99. Effective date. This Act takes effect upon
3becoming law.".