Tiny Regulatory Wrinkles Can Create Big Problems for Clinical Trials

Beware the 234,812-word federal regulation bearing gifts. Even if a new law wasn’t intended to cover clinical research, it can still sneak up and impact the way sites do business, says David Vulcano, LCSW, MBA, CIP, RAC, with HCA (Hospital Corporation of America) in Nashville, Tenn.


David Vulcano, LCSW, MBA, CIP, RAC, Hospital Corporation of America

“Sometimes, the word ‘research’ isn’t even in a federal regulation,” he says. Don’t let that fool you. As an example, the Affordable Care Act (ACA), which clocks in at a Harry Potter-book size with more than 234,000 words, impacts subject recruitment in ways many probably didn’t anticipate, Vulcano notes. For example, because the Act provides access to insurance to millions, it also changed the dynamic for many potential trial participants. In some instances, subjects elect to participate in a trial because they have no other insurance. However, by adding people to the insurance rolls, the Act may have inadvertently impacted trial recruitment, Vulcano says.

Conversely, subjects with individual insurance may be more likely to participate in oncology trials and others with a standard-of-care arm, he notes. The ACA also changed the deductibles charged by many insurance carriers. Generally, they went up. “Have a frank discussion with your subject about their deductibles,” Vulcano says. In some cases, it might make more sense to enroll the trial subject in June, after a deductible is met, rather than the early part of the year. It stands to reason that recruitment and retention numbers will rise if a patient’s deductible is addressed beforehand.

Unfortunately, most clinical trial professionals don’t have the time to wade through long regulations. In some instances, they don’t even know which ones to focus on, Vulcano says.

The ACA has been around since 2009 and continues to engender uncertainty. Regardless of that fact, Vulcano adds, “Lately people are not so much asking what the ACA will bring in the next few years, but what happens to the research industry if it goes away,” as many presidential candidates polling very well are those who are calling for a complete repeal. “Another reshuffling of the insurance card deck?” he muses. “Well, with a complete repeal, yes, it would, among changing many other things, eliminate the Sunshine Act.”

Making matters more challenging, there are any number of new pieces of legislation that bear watching. One example: “Right to Try” legislation allows Americans to try a drug or device that has passed Phase I of the Food and Drug Administration’s approval process, yet hasn’t reached a local pharmacy because it is still working its way through the regulatory labyrinth. As of January 2016, such legislation had already passed in at least 24 states.

How should sites prepare for it? “It can be a real dilemma,” Vulcano says. He’ll be addressing it and other important regulations on the horizon during his session at the ACRP 2016 Meeting & Expo in Atlanta, Ga., in April.

Learn more about his session, 2016 Update: U.S. Healthcare Changes and How They Affect the Clinical Research Industry.

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