§ 5404. Improving access to cancer clinical trials.

516 words·~2 min read·/pa/title-35/chapter-54/5404

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(a)Inducement.-- All sponsors of cancer clinical trials shall inform potential patient-subjects at the time of the informed consent process of the following:

(1)Reimbursement for travel and ancillary costs is available to all enrollees based on financial need.

(2)Coverage of the travel and other ancillary costs is done to eliminate financial barriers to enrollment in order to retain patient-subjects in the clinical trial.

(3)Family, friends or chaperones that attend the cancer clinical trial treatments to support the patient-subject are eligible for reimbursement of their travel and ancillary expenses.

(b)Reimbursement.--

(1)Reimbursement of travel, ancillary medical costs and other direct patient-incurred expenses related to trial participation shall not be considered an inducement to participate in a cancer clinical trial.

(2)Reimbursement for travel and ancillary expenses shall not be considered coercive or exerting undue influence to participate in a trial; instead, reimbursement shall be considered a means to create parity in clinical trial access and remove a barrier to participation for financially burdened patient-subjects.

(c)Expenses and registration.-- The following apply:

(1)Government, industry, public and private foundations, corporations and individuals may offer financial support to patient-subjects, or the family, friends or chaperones of patient-subjects, to cover ancillary costs through their support of a third-party reimbursement entity.

(2)A third-party reimbursement entity shall register with a department-approved Pennsylvania college or university with a school of public health. Registration must occur within 30 days of the date the third-party reimbursement entity first reimbursed a patient-subject, or the patient-subject's family, friends or chaperones, for travel or ancillary expenses related to a cancer clinical trial conducted within this Commonwealth.

(3)Registration under paragraph

(2)shall include:

(i)The name of the third-party reimbursement entity.

(ii)The third-party reimbursement entity's legal and tax status.

(iii)The third-party reimbursement entity's employer or other similar identification number.

(iv)The names of the third-party reimbursement entity's principal officers and directors.

(v)The names of donors of $5,000 or more to the third-party reimbursement entity.

(vi)Appropriate identifying information, as determined by the department, regarding other sources of funding from a source of $5,000 or more.

(vii)Other information as the department deems necessary or appropriate.

(4)A third-party reimbursement entity registering under paragraph

(2)shall update the registration no less than once annually utilizing forms and regulations developed by the department.

(5)A third-party reimbursement entity that fails to register as required by this subsection shall be subject to a penalty of no more than $300 imposed by the department.

(d)Reimbursement programs.-- Reimbursement programs must comply with the following:

(1)Reimbursement programs that cover ancillary medical and travel expenses must be reviewed and approved by the IRB or IEC in conjunction with their review of the proposed clinical trial. The IRB or IEC must consider whether the reimbursed patient-subjects are recruited fairly, informed adequately and paid appropriately.

(2)The nature of the ancillary support and general guidelines on financial eligibility must be disclosed in the informed consent process.

(3)The reimbursement process must conform to Federal and State laws and guidance.