|Posted:||February 8, 2017 01:20 PM|
|From:||Senator Andrew E. Dinniman|
|To:||All Senate members|
|Subject:||Cancer Clinical Trial Access for Pennsylvania Patients (TAPP)|
A Pennsylvanian will be diagnosed with cancer approximately every four minutes, and every ten minutes a Pennsylvanian will die of cancer.
According to the National Cancer Institute, Cancer Clinical Trials Resource Guide, some of the barriers preventing individuals with cancer or at high risk of developing cancer from participating in clinical trials are direct and indirect financial and personal costs, including travel and child care expenses.
Diverse patient participation in clinical trial depends, in part, on whether a participant can afford ancillary costs like transportation, childcare, or lodging during the course of his or her participation. A national study in 2015 found that patient households making less than $50,000 annually were almost 30 percent less likely to participate in clinical trials. This disparity threatens one of the most basic ethical underpinnings of clinical research, the requirements that the benefits of research be made available equitably among all eligible individuals.
Some corporations, individuals, public and private foundations, health care providers, and other stakeholders are hesitant to contribute to, or accept funds from, programs that are organized to alleviate financial burdens faced by patients who wish to participate in clinical trials and their caregivers, due to concerns that the FDA and or other federal regulators would view the payments made from those funds as prohibited inducements for patients to receive the health care services provided during clinical trials.
I will soon introduce legislation to further define and establish a clear difference between what is considered “inducement” (paying a person money including a lump sum or salary payment) for a patient to participate in a cancer clinical trial and the reimbursement of expenses for participating in a clinical trial.
I hope you will join me in sponsoring this legislation to ensure all Pennsylvanians continue to benefit from advances achieved through clinical research.
Introduced as SB576