At a conference a few months ago, I spoke with a clinical trial investigator who complained that he still received paper checks in the mail from some sponsors and CROs, often with little or no information as to which protocol or trial procedure it referred to. It got me thinking. Why are we making this so hard for sites? Site personnel aren’t payments experts. They don’t want to spend time tracking down payments. They don’t have the technology expertise to care about how the payments are done. They just want their money deposited in their bank account on time, and with the associated documentation that explains what the payment is for. This is standard across other industries, so why should it be different for clinical trials?
This investigator is definitely not alone. In 2016, the DrugDev investigator survey found that global investigators rated the rise in cost of trial delivery and slow payment from sponsors/CROs as the top two burdens associated with clinical trial operations (rated as very or extremely burdensome by 45% and 44% respectively). When you listen further to what sites say about payments, it becomes apparent that site satisfaction levels are closely linked to the frequency, accuracy and timeliness of site payments. Specifically, key site concerns include: little to no visibility into payment activities, extremely limited documentation, inconsistent payment amounts and lack of predictability on payment timing. All of this exists on a backdrop of increased complexity for the sites, with 84% stating that protocol complexity has increased study delivery costs, primarily due to lower enrollment and increased screen failure rates. This effect on screen failures then further exacerbates the payment issue, as sites have also indicated that they have real concerns about little or no payments for screen failures (51% rated this extremely or very difficult).
Payments technology exists today to help address these site concerns, through connectivity to existing sponsor systems (e.g., EDC, CTMS) and automation of standard activities such as invoice preparation, documentation of pass-through costs and online submission of payment requests. What this means for the site is not only a broad array of online functionality, but increased transparency into what each payment covers, all accessible through self-service reports and dashboards. In addition, some of the available payment technologies also facilitate the communication and workflow between sites and sponsors related to sign-off and approval of contracts, amendments, budgets and invoices, thus addressing other key site burdens in addition to payments.
When asked how valuable sites would find the ability to upload a payment invoice to a secure payment system instead of submitting invoices via email, 75% of global investigators rated this payments functionality as somewhat, very or extremely valuable (see Graphic). This result is not surprising given that automated payments technology addresses many of the factors contributing to the large burden associated with clinical trial delivery. Of the global countries surveyed, this feature was rated most highly by Brazil, India and Argentina.
Historically, however, site payments only became a priority for a sponsor/CRO when sites began to escalate issues due to payment delays, lack of transaction transparency and general confusion about how payments have been calculated. For years, the industry has considered late payments, inaccurate amounts and poor visibility as simply part of the cost of doing trials that should be accepted by sites.
Thankfully, the tide is changing with more recognition that issues related to payments are challenging the sustainability of sites as crucial participants in the clinical research enterprise. According to a 2016 Site Survey conducted by the Society for Clinical Research Sites (SCRS), 66% of sites have less than three months operating cash on hand, and the Clinical Trials Transformation Initiative (CTTI) has linked payment delays to the high turnover rates of clinical trial investigators.
Sponsors and CROs that want to be a provider of choice for sites are turning toward specialty payments providers that have the technology, experience and know-how to simplify the payments process. Sites shouldn’t have to tolerate paper checks, spreadsheets, delayed payments and multiple print/fax/scan/email processes any longer. The time has come to make payment automation the gold standard across all clinical trials so that sites can instead spend their valuable time helping patients and conducting research in support of bringing new treatments to market.
Elisa Cascade is an expert in clinical trial innovation and technology with over 25 years of industry experience. She leads DrugDev’s Data Solutions business working with sponsors, CROs, and sites to improve clinical trial operations through standardization, industry-wide collaboration (including TransCelerate’s Investigator Registry and Investigator Databank), and a beautiful technology experience. Email email@example.com or tweet DrugDev at @drugdevinc.
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