Downturn in Research Payments Could Change Trial Landscape
A decline in spending on clinical research following implementation of the Physician Payment Sunshine Act could change the clinical trial landscape if it becomes an ongoing trend, an expert warns.
Thomas Sullivan, editor of Life Science Compliance Update, recently co-authored an analysis of Centers for Medicare & Medicaid Open Payments data and found a 32 percent drop in industry spending on U.S.-based clinical research.
Drug- and devicemakers spent about $1.5 billion on research payments from August through December 2013 — the first reporting period under the Affordable Care Act. However, this dropped to about $1 billion in the last five months of 2014.
This “suggests a disturbing trend that we will want to watch closely moving forward,” Sullivan says. “At the end of the day, you may have less U.S. patients enrolled in U.S. clinical trials and FDA may have to change the way we look at how drugs are approved,” he tells CTA.
According to Sullivan’s analysis, the decrease isn’t specific to a certain type of recipient, geographic area or specialty. Specialties with the steepest drops include hematology/oncology, down 56 percent; medical oncology, down 34 percent; and psychiatry, off 48 percent. Certain states also saw drastic declines, including Pennsylvania, California, Texas, Florida, New York, Minnesota and Indiana.
Possible reasons for the decrease in funding include:
“A decline in domestic research would be an unfortunate unintended consequence of transparency,” Sullivan says. “I think you have physicians who don’t necessarily want their names associated with these very large amounts of money when they actually received very little of the trial money.”
Decline Was Foreseen
The Association of Clinical Research Organizations predicted this development prior to the ACA, he notes. A survey by the group found that about one-third of physicians planned to reduce their participation in trials as a result of Open Payments scrutiny.
Meanwhile, as physicians move into the employee-physician model, they have less time to spend on clinical trials, Sullivan says. Doctors are reimbursed based on relative value units, and it can be difficult to categorize things like investigator meetings into RVUs.
To address this problem, Sullivan recommends that manufacturers be clear upfront about what costs will be associated with the physician’s name in the Open Payments database. Loans of equipment like refrigerators should be included in the contract and made “part of the research grant so you don’t have to give them a refrigerator when it’s over with,” he says.
“Calculate the value of the study drug and make it clear to the physician that this is how you’re valuing it. Anything manufacturers can do to inform [physicians] in advance of what they’re reporting is a very useful thing,” Sullivan adds.
CROs should also make themselves “as friendly as possible” to investigators, Sullivan adds. A CRO should let the physician know the exact amount that will be reported so that they aren’t confused, he says.
While Sullivan hopes the decline isn’t a long-term trend, it mirrors developments in Massachusetts and other states that adopted similar transparency rules before the ACA and, hence, isn’t unexpected, he says. Meanwhile, it will be important to see if any of the drop was due to manufacturers’ delaying publication of research payments, he tells CTA. — April Hollis
Subscribe to Clinical Trials Advisor NOW and save $200 off the regular one-year price of $645 — plus receive a FREE copy of our webinar, Electronic Informed Consent for Clinical Trials: Best Practices – a $347 value!
LINKS TO KEY DOCUMENTS — Need to read regulatory references, guidances, enforcement actions, and other documents? Simply click on the source documents in your electronic issue.
ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.
Copyright ©2018. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing