November 5, 2018
Pennsylvania Gov. Tom Wolfe has signed legislation allowing drug sponsors to pay the expenses of patients who enroll in their clinical trials.
The new law, which takes effect immediately, makes Pennsylvania the second state after California to greenlight reimbursing participants in an effort to beef up trial enrollment and retention.
The measures make clear that the payments do not amount to coercion or inducement, clearing the way for sponsors and researchers to reimburse patients for travel and other expenses often cited as recruitment and retention obstacles.
A similar bill stalled in Florida earlier this year, but other packages are working their way through the Texas and Massachusetts legislatures.
The new legislative push is the culmination of years of lobbying by the Lazarex Foundation — a California-based nonprofit group that has worked to ease economic and other barriers to trial enrollment — and its allies.
“We want to see a shift from the patient bearing the burden of trial costs… back to industry where they include those out-of-pocket expenses as a rule,” Lazarex Chairman and Founder Dana Dornsife tells CenterWatch. “That’s going to take a while, but we need to get them to start thinking about this differently.”
The organization’s efforts were rewarded by an FDA guidance issued earlier this year stating that the agency didn’t consider reimbursements to be coercion.
The move was “a game changer for us,” Dornsife says. But she notes legislation is still crucial to reassure skittish drug companies that payments are acceptable, adding that if the foundation’s legislative efforts are successful in the eight states it has targeted, it will have reached 45 percent of the nation’s comprehensive cancer centers and nine of the nation’s 10 most populous cities.
On its face, there’s not necessarily anything unethical about compensating patients for their expenses — or even compensating them for their time, as in the case of healthy volunteers in phase I studies who give up days and even weeks at centers, says David Forster, chief compliance officer at WCG.
But “the whole calculus” can change when you’re talking about enrolling sick people in trials, he says. That’s where an IRB has to earn its keep.
“What the IRB needs to look for,” he adds, “is the amount being paid just so much that somebody is going to make a bad decision? If the IRB has done its job, and the patient is eligible for the protocol, then there shouldn’t be an ethical problem.”
Dornsife says the group is hoping to recruit a new legislative sponsor in Florida and is cautiously optimistic legislation will pass in at least three more states — New York, Ohio and Illinois — by 2020.
The legislation isn’t particularly controversial. In Massachusetts, for example, bill sponsor state Sen. Richard J. Ross, a Republican, is so sure it will pass that he’s hoping to get it approved during the informal legislative session, akin to a consent agenda, spokesperson Rachel Purewal says. Adding to their appeal, none of the packages require states to pony up any tax dollars.
But Dornsife says it can be difficult “to convince legislators that they need to create a friendly environment” for clinical trials. “You have to dot all the Is and cross all the Ts,” she says.
That can be arduous. In Florida — which only has a part-time legislature that meets for a frenetic 60 days, beginning in March — the bill simply fizzled out.
“The people who we thought were going to be House sponsors never materialized,” says Valerie Clarke, a legislative aide to state Sen. David Simmons, who co-sponsored the measure there. “I don’t know if it’s controversial, because it never went anywhere. It never went anywhere at all.”
Patient reimbursement is also a sticky issue for drug companies, says Jonathan Zung, president of Clintrax Global, a clinical trials services company.
“You want to make it easier for patients,” he tells CenterWatch. But “you don’t want to induce somebody to be in the trial who perhaps didn’t want to be in a trial.”
“It is a total balancing act,” he adds. “You want your trial to be clean and free of any sort of contamination … especially in trials where the endpoints are a little more subjective.”
-By Bill Myers