Earlier this year, site payment issues were front and center at the European Site Solutions Summit that took place in Barcelona. The Summit, presented by the Society for Clinical Research Sites (SCRS), provides a forum for sites, sponsors, and CROs to collaborate and discuss opportunities to improve clinical trials.
In this Q&A, Dan Milam, VP of Global Engagement for SCRS, discusses the Summit, the issue of site payments, and what progress is being made.
Ed Miseta: The recent European Site Solutions Summit featured key presentations on site payments. Why is this still such a critical issue for sites?
Dan Milam: SCRS conducts an annual survey of sites we call the Site Landscape Survey. It benchmarks the most important aspects of site sustainability. In 2016, 66 percent of sites globally reported having less than three months’ worth of operating cash. Whether sponsors and CROs pay sites monthly or quarterly is not just a timing issue. This is an issue of whether or not sites can stay in business.
Although this is an important issue worldwide, most studies have thus far focused on the U.S. SCRS and Greenphire recently conducted a global survey that for the first time reveals more about site financial operational processes for handling study payments. It also examined the associated patient reimbursements and how the payment processes and systems used by sponsors and CROs interact to impact site financial stability.
Miseta: What were some of the key findings?
Milam: Not surprisingly, we found sites expect to be treated as valued business partners, which in most business relationships means being paid within 30 days. This has always been a core element of SCRS advocacy. We also discovered there are four key improvements needed from payers to support site sustainability:
We also found these four key improvements affect the patient directly through a complex network of financial incentives and relationships which we explain more fully in the paper.
Miseta: Are we seeing any progress in getting these problems addressed?
Milam: I think we are beginning to see solutions adopted to alleviate this very real site burden. Sites are looking forward to changes in the timeliness of payments. The legacy system of paying sites on a quarterly basis is a carryover from when data were written on triple carbonless paper, verified by the monitor, and then pulled and entered into a system at a data entry center. That time is long gone, and the barriers to payment and accounting efficiency for sites are slowly going, too.
At the 2016 Global Site Solutions Summit, we highlighted a long list of sponsors and CROs that sent attendees with the word “site” in their title. Partnering with sites has become a key strategic decision for most sponsors and CROs. They invite us to come to their offices and tell them more about what the sites are saying. Additionally, there are vendors providing truly innovative solutions and working closely with sites to make sure these solutions truly meet the sites’ needs and bring the voice of the site into the development of new products.
Miseta: Following the Summit, there was a half-day meeting of an SCRS European Site Advocacy Group (SAG) to discuss the payment process across Europe. Is this a global problem?
Milam: Yes. This problem is by no means unique to the U.S. market. While certain aspects of how sites need to be paid vary by region, the need for prompt payment does not vary. In fact, our survey found that certain negative outcomes associated with late payment were more likely to occur outside the U.S. For example, sites that don’t receive payment may have to stop screening. This is a huge red flag indicating how delayed payments hurt the industry as a whole and, ultimately, hurt patients that are waiting on new medicines.
Miseta: The meeting focused on the impact of manual, administrative burdens on the clinical trial experience. What are some of the insights gleaned from the meeting?
Milam: Greenphire sponsored the session, and the group included site staff representatives from more than seven different regions in the EU. All were eager to learn about the automation tools available. We found there is a gap between the tools that are available and getting them to the sites. The tools are generally purchased by sponsors and CROs, so we talked about how sites can advocate to their payers that these tools need to be part of their next study. Inefficiencies in patient reimbursement and site payment processes simply cost everyone too much time and money to not push for change. While regional differences existed, there was a common theme across all of the sites, which is to reduce the manual administrative burden so the staff can focus on the patient experience and supporting the trial.
What was also very interesting were the misconceptions around the room about what was “allowed” when it came to patient reimbursement and compensation for clinical trial participation. This generated a lively discussion about how to get the approval from ethics committees and how to request this from their sponsor and CRO partners in the contract.
Miseta: What can SCRS continue to do going forward to help sponsors, sites, and CROs resolve this issue?
Milam: Our biggest focus is to support site sustainability and empower sites around the world. To do that, we work with all stakeholders – sponsors, CROs, and solution providers – to be the voice of the site. SCRS focuses on site sustainability, which was neglected for a long time and now has the attention of a lot of brilliant and energetic people from every area of industry. We will continue to facilitate gathering and sharing information about sites, and bringing together collaborations that lead to real improvements for sites.