Legislature passes bill to improve access to cancer clinical trials

In Clinical Studies News by Barbara Jacoby

From: dailylocal.com

WEST CHESTER—A new law designed to improve access to clinical trials for Pennsylvanians battling cancer is heading to the governor’s desk, state Senator Andy Dinniman said.

House Bill 126 unanimously passed the Pennsylvania Senate this week after receiving unanimous approval in the House earlier this year. The bill was amended to include language from Dinniman’s Senate Bill 576, which clarifies what are considered inducements for patients to participate in cancer clinical trials.

“While there’s been some progress at both the state and federal levels in enacting ‘right to try’ laws for terminally ill patients, many families still struggle to access clinical trials due to the excessive costs associated with them, which can include everything from transportation to childcare to lodging during one’s treatment,” Dinniman said.

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.

Meanwhile, 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.

House Bill 126 clarifies the 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.

“This legislation makes it clear that such funds are reimbursements to assist patients with the costs associated with clinical trials rather than payments to encourage their participation,” Dinniman said. “It’s my hope that it will both help more patients access the funds and resources need to participate in potentially life-saving clinical trials and advance groundbreaking cancer research by broadening the scope of participation in such trials.”

Dinniman also credited Lt. Governor Mike Stack, who spearheaded the effort to pass such legislation in his previous role as a state Senator, as well as the Lazarex Cancer Foundation, which provides assistance with the costs of clinical trial participation.

House Bill 126 also permits entities such as summer camps, colleges and universities, restaurants, amusement parks, sport facilities, daycares and other facilities to have non-patient specific epinephrine auto-injectors in their facilities in case of emergency situations.