Establishes the clinical trial access and education fund to provide grants to eligible applicants to provide certain services for patients with life-threatening or disabling conditions or diseases.
TITLE OF BILL: An act to amend the public health law, in relation to establishing the clinical trial access and education fund
PURPOSE OR GENERAL IDEA OF BILL:
This bill creates the Clinical Trial Access and Education Fund, a state grant program within the department to provide funding to address the major barriers to participation in clinical trials in New York State.
SUMMARY OF SPECIFIC PROVISIONS:
Section 1 amends article 24 of the public health law by adding a new section 2424, the Clinical Trial Access and Education Fund.
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.
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 8O% 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-forprofit 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:
2009; A.1805 - passed Assembly 2010: A.1805 - passed Assembly 2011-12: A.807 - passed Assembly
None - subject to available appropriations.
This act shall take effect immediately.
STATE OF NEW YORK ________________________________________________________________________ 6442 IN SENATE January 24, 2014 ___________Introduced by Sen. RIVERA -- read twice and ordered printed, and when printed to be committed to the Committee on Health AN ACT to amend the public health law, in relation to establishing the clinical trial access and education fund THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM- BLY, DO ENACT AS FOLLOWS: Section 1. The public health law is amended by adding a new section 2424 to read as follows: S 2424. CLINICAL TRIAL ACCESS AND EDUCATION FUND. 1. DEFINITIONS. FOR THE PURPOSES OF THIS SECTION, THE FOLLOWING TERMS SHALL HAVE THE FOLLOW- ING MEANINGS: A. "ELIGIBLE APPLICANT" MEANS (I) A MEDICAL SCHOOL THAT SPONSORS A CLINICAL TRIAL, (II) A NOT-FOR-PROFIT ORGANIZATION WITH EXPERIENCE AND EXPERTISE WORKING WITH PATIENTS WITH LIFE-THREATENING OR DISABLING CONDITIONS OR DISEASES, (III) A HEALTH CARE PROVIDER ORGANIZATION, ASSO- CIATION OR SOCIETY, (IV) A GENERAL HOSPITAL DEFINED IN ARTICLE TWENTY-EIGHT OF THIS CHAPTER, (V) A COUNTY OR CITY HEALTH DEPARTMENT, OR (VI) A MUNICIPALITY. B. "CLINICAL TRIAL" SHALL HAVE THE SAME MEANING AS IN SUBDIVISION TWO-B OF SECTION FORTY-NINE HUNDRED OF THIS CHAPTER. 2. ESTABLISHMENT OF FUND. THERE IS HEREBY ESTABLISHED WITHIN THE DEPARTMENT A CLINICAL TRIAL ACCESS AND EDUCATION FUND. SUBJECT TO APPRO- PRIATIONS, THE DEPARTMENT SHALL PROVIDE GRANTS TO ELIGIBLE APPLICANTS ON A COMPETITIVE REQUEST FOR PROPOSAL BASIS TO PROVIDE ONE OR MORE OF THE FOLLOWING SERVICES TO PATIENTS WITH LIFE-THREATENING OR DISABLING CONDI- TIONS OR DISEASES, AS SUCH TERMS ARE DEFINED IN SECTION FORTY-NINE HUNDRED OF THIS CHAPTER, TO FACILITATE ACCESS TO OR EDUCATION ON CLIN- ICAL TRIALS OF TREATMENTS FOR THE PATIENT'S CONDITION OR DISEASE: A. TRANSPORTATION SERVICES AND LODGING TO PROVIDE PATIENTS WITH ACCESS TO CLINICAL TRIALS OR OTHER RELATED TREATMENTS WHILE ENROLLED IN A CLIN- ICAL TRIAL OR TO ACCESS TESTING AND OTHER SERVICES TO DETERMINE PATIENT ELIGIBILITY FOR A CLINICAL TRIAL; B. PATIENT OUTREACH AND EDUCATION SERVICES TO EDUCATE PATIENTS, THEIR FAMILIES AND HEALTH CARE PROVIDERS ABOUT THE EXISTENCE OF AND HOWEXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD01585-01-3 S. 6442 2
PATIENTS MAY ENROLL IN CLINICAL TRIALS, UNDER SECTION TWO HUNDRED SEVEN OF THIS CHAPTER; AND C. PATIENT NAVIGATION SERVICES TO HELP PATIENTS TO DETERMINE IF THEY ARE ELIGIBLE FOR CLINICAL TRIALS, TO HELP PATIENTS TO ENROLL IN CLINICAL TRIALS AND TO ASSIST PATIENTS IN DEALING WITH INSURANCE OR OTHER ISSUES WHICH SERVE AS BARRIERS TO PATIENT ENROLLMENT IN CLINICAL TRIALS. 3. APPLICATIONS. THE COMMISSIONER SHALL ESTABLISH AN APPLICATION PROC- ESS BY WHICH ELIGIBLE APPLICANTS MAY APPLY FOR A GRANT UNDER THIS SECTION. THE APPLICATION SHALL INCLUDE: A. THE GEOGRAPHIC AREA IN WHICH THE SERVICES SHALL BE PROVIDED; B. A DETAILED DESCRIPTION OF THE SERVICES TO BE PROVIDED; C. APPLICANT'S EXPERIENCE WORKING WITH PATIENTS WITH LIFE-THREATENING OR DISABLING CONDITIONS OR DISEASES; D. APPLICANT'S ABILITY TO PROVIDE PATIENT OUTREACH OR CLINICAL TRIAL EDUCATION AND NAVIGATION SERVICES, OR COORDINATE OR PROVIDE TRANSPORTA- TION AND LODGING FOR PATIENTS; AND E. ANY OTHER INFORMATION THAT THE COMMISSIONER DEEMS RELEVANT AND APPROPRIATE. THE COMMISSIONER SHALL GIVE PREFERENCE TO ELIGIBLE APPLICANTS WHO HAVE EXPERIENCE AND EXPERTISE WORKING WITH PATIENTS WITH LIFE-THREATENING OR DISABLING CONDITIONS OR DISEASES AND PROVIDING PATIENT OUTREACH, EDUCA- TION AND HEALTH CARE NAVIGATION SERVICES. 4. REPORTS. GRANTEES SHALL FILE AN ANNUAL REPORT WITH THE COMMISSION- ER, IN SUCH FORM AND WITH SUCH INFORMATION AND DATA AS THE COMMISSIONER PRESCRIBES DETAILING THE EXPENDITURE OF GRANT FUNDS AND SUMMARIZING THE EFFORTS UNDERTAKEN TO INCREASE PATIENT ACCESS TO CLINICAL TRIALS. 5. THE COMMISSIONER SHALL MAKE REGULATIONS REASONABLY NECESSARY TO IMPLEMENT THE PROVISIONS OF THIS SECTION. S 2. This act shall take effect immediately.