Establishes the clinical trial access and education fund to provide grants for certain services for patients with life-threatening or disabling conditions/diseases

Subdivision 1 of the new section provides definitions of eligible applicant and clinical trial.

Subdivision 2 establishes the clinical trial access and education fund within the department to provide grants to eligible applicants on a competitive request for proposal basis to provide certain services to patients with life-threatening or disabling conditions or diseases. Such services would include: transportation and lodging to patients so they may access a clinical trial or related treatment; patient outreach and education on the existence of and how to enroll in clinical trials; and patient navigation services to help patients determine eligibility for clinical trials.

Subdivision 3 establishes an application process for eligible applicants and states that the commissioner shall give preference to applicants who have experience and expertise providing patient outreach, education, navigation and other services to patients with life-threatening or disabling conditions or diseases.

Subdivision 4 requires grantees to file an annual report with the commissioner summarizing how they utilized the grant funds to increase patient access to clinical trials.

Subdivision 5 requires the commissioner to make any necessary regulations to implement the section.

Section 2 establishes the effective date.

Justification

New therapies to treat cancer and other life threatening diseases are being developed at an increasing pace, Clinical trials are the most effective, scientifically valid method of determining the benefits of experimental treatments. They are critical to improving health care and mortality rates for patients with cancer and other life-threatening diseases. While fewer than 5% of adult cancer patients participate in clinical trials, 60% of pediatric cancer patients do. This large number of pediatric enrollees has led to the discovery of groundbreaking therapies and a survival rate of over 80% for childhood cancer. To achieve a similar rate of success for adults with cancer and other diseases, information and access to clinical trials must be made more widely available to patients and their treating health care providers.

A number of studies have looked at the reasons for low adult patient participation in clinical trials. One recent study conducted by the University of California Davis Cancer Center surveyed oncologists regarding patient and physician decision-making about participation in clinical trials. Of the 276 patients assessed, oncologists only recommended that 76 patients participate in clinical trials and only 39 patients or 14% actually enrolled in the trials. The two most common reasons that patients cited for declining to participate were a desire for other treatment and the distance from the cancer center. The study authors made a series of recommendations to overcome these barriers including the need for greater physician and patient education on the status, availability and benefits of clinical trials as well as the need to address geographical issues that serve as strong deterrents to clinical trial access.

The Clinical Trial Access and Education Fund will address these major barriers identified by the clinical research and anecdotally from patients and providers in New York, it will provide grants to non-for-profit community groups, health care provider associations and research centers that conduct clinical trials so they may provide and/ or facilitate patient navigation, transportation, lodging and patient and provider education to achieve greater patient participation in clinical trials.

Prior legislative history

2008: A.10624 - Passed the Assembly

Fiscal implications

None - subject to available appropriations.

Effective date

This act shall take effect immediately.