One major challenge that still exists in clinical research is budget negotiations and payments to sites. Most would agree that trust and communication are vital to keeping those functions operating efficiently. The process put in place must also work for all stakeholders involved in the process.
Unfortunately, budgets and payments remain top concerns for sites, even as SCRS (the Society for Clinical Research Sites) has made resolving them a critical priority. The site organization has long advocated for monthly payments and, in 2015, convened a working group consisting of 31 industry partners and stakeholders. The SCRS group has already produced one paper, which outlined recommended best practices to produce a healthy and transparent financial exchange between sponsors, CROs, and sites.
Over the last few years technology solutions have continued to improve. Payment solutions are now increasing the transparency sites have over the payment process, while tracking and sharing information relating to payments.
In its continuing efforts to resolve these problems, SCRS, in collaboration with software solutions provider Medidata, has produced a white paper titled Site Budget Development and Payment Systems: A Call For Transparency from Clinical Research Sites. The report compiles the results of a survey (and follow-up interviews) started at the beginning of 2017 to determine how technology could aid in creating a more streamlined and transparent budget and payment system.
What Features Are Most Valuable?
“If a system were provided to your clinic free of charge, what features of it would you find most valuable?” This was a question asked of respondents. Scoring highest, at 98 percent, was a system that allowed users to see the remaining amount due to a site from an ongoing study. That was followed by:
Other desired features noted by more than 80 percent of respondents include e-learning tutorials, ability to create e-invoices, 24/7 access to revenue earned and payment status, and the ability to upload invoices to a portal to facilitate payment.
All electronic system features included in the survey were selected by greater than 60 percent of respondents as “very important” or “extremely important.” In fact, any element of technology utilized for greater transparency was deemed desirable. Sites that had been in operation for less than 10 years had a greater desire for certain functionalities than the more experienced sites.
These findings are not surprising. Timely payments are important to clinical sites, and previous surveys have found sites continue to operate on a narrow profit margin that averages 13 percent. When a site has little experience, navigating the payment challenge is all the more difficult. Unfortunately, more than 50 percent of all investigators started in clinical research after 2012. Sixty-six percent of sites also report having less than three months operating cash on hand.
Payment With Documentation Within 30 Days
Sites need to be paid in a timelier manner. This issue is not new and continues to be a pain point. In fact, not much has changed since 2012 when SCRS first identified payment within 30 days and payments backed up by supporting information as 2 of the top 5 concerns for sites. Both concerns, however, now have technology solutions available.
In the most recent survey, 90 percent of respondents noted monthly payments are “very important” or “extremely important.” In the U.S., that response rate was 21 percent higher than for sites outside the U.S. As this issue remains a critical factor to site sustainability, SCRS continues to push for site payments within 30 days of data entry, accompanied by support information.
According to survey respondents, each payment should be accompanied by information including:
Access to financial information also remains a challenge. One-third of sites use a clinical trial management system (CTMS). Most sites that have a CTMS have also been doing research for more than 10 years. But another reality is that 60 percent of sites use less sophisticated systems to manage their accounts receivable and payments. Unfortunately, those less sophisticated systems still include paper and spreadsheets. Approximately 4 percent of all sites use no financial tracking system at all.
Additionally, most sites report not having dedicated accounting staff, meaning budgeting and payments at those locations are handled and managed by the same site staff responsible for patients. When that happens, patient interactions suffer. This situation also leads to physicians leaving clinical research. When physicians are asked why they don’t do research, or stopped doing it, administrative burden is frequently cited.
Insights Into Budget Negotiation
Finally, the SCRS survey addressed budget negotiation. The report notes budget templates are created in one of two ways – line item or per visit. Line item budgets are used in 58 percent of budgets prepared in the U.S. They have been steadily growing in other parts of the world. Line item budgets ensure sites are adequately compensated for study-related activities. Still, one respondent noted it is not unusual for a site to receive a per-visit budget but get paid on a line item basis. She adds that when receiving a per-visit budget, she often wonders what is being hidden. Only by delving into the spreadsheet is she able to see how the per-visit budget was created.
Another respondent noted, “Even when a line item budget is provided, it often fails to capture all of the elements required by the site to fulfill compliance with the protocol.” If we are trying to build better relationships, trust, and transparency between sponsors/CROs and their sites, this seems the wrong way to go about it.
The sharing of the budget template is usually done via email. In the survey, 77 percent of respondents noted they would find value in a budget template that allowed for budget negotiations with sponsors/CROs. There was no difference in that number between sites in the U.S. and those overseas. Again, sites with less than 10 years of experience indicated they would find more value in such a platform.
The survey also found that, on average, 10 weeks is spent negotiating every clinical trial budget and contract. With accounting staff at sites, that becomes a huge burden for site staff that should be interacting with patients. Providing sites with access to an online platform where the budget template could be shared and negotiated with greater transparency could reduce the time required to finalize the budget, and build better relationships.
The survey was global in scope and included 218 site representatives. Most were located in the U.S. and had been involved in clinical research for more than 10 years.