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New “Sunshine” rules that require biopharmaceutical and medical device companies to report payments to physicians and teaching hospitals made through contract research organization (CROs) and other third parties create new challenges for sponsor data operations and relationships with vendors. In its final rules, the Department of Health and Human Services (HHS) clarified that pharma companies are responsible for disclosing payments for research transmitted by third parties. And research payments cover preclinical testing, as well as clinical trials in the final regulations.
Meeting all these requirements, advises Kim Zahan, director of R&D financial compliance at GlaxoSmithKline, requires clearly defined relationships with health care professionals, CROs, site management organizations and event management suppliers, among others.
Zahan’s main recommendation for sponsors: Reduce your number of vendors. Companies that deal with hundreds of vendors are “going to drown,” he warned health care compliance officers at the February Disclosure, Transparency and Aggregate Spend Summit in Washington, D.C. Zahan explained that Glaxo is moving to “preferred vendor agreements” with just a few CROs; a main benefit is streamlined collection of data on research expenditures.
Timing of data collection is a critical issue, he pointed out. Do you report a payment when you pay the CRO, or when the CRO pays the institution? And what about prepayment? These issues should be spelled out in “very solid contracts” with CROs that reflect company policies and timing for collection of data, data disclosure and audit policies. Terms need to be clearly defined consistent with other disclosure practices, said Zahan, and data from the CRO has to be reconciled with company records on what it paid the vendor.
Collection of payment data related to investigator meetings illustrates the complexities. There should be invoices for each individual at the meeting, and all the invoices have to match the total. It helps to have basic information up front on who will be at the meeting and what fees are involved.
Standardization of data collection is a plus, Zahan added, suggesting that sponsors provide standard templates and train vendors on their use. Ideally, data collection and transfer is automated as much as possible, with vendor information on individual identifiers for doctors integrated into sponsor processes as much as possible and certified by the vendor. Sponsors also may want to conduct sample audits, reconcile data records to disclosures on the ClinicalTrials.gov website, and create internal reports that flag “exceptions.”