The data gathered at investigative sites during clinical trials is the backbone of the pharmaceutical and medical device development process. Without it, assessing the efficacy and safety of therapies would simply be impossible.
Whether they are linked to a medical practice, part of an academic medical center (AMC), or operate independently, investigative sites are an important resource.
Many sites struggle financially under the burden of a rapidly changing clinical ecosystem. Sites are responsible for much of the non-patient-facing tasks that are necessary for running a clinical trial - finding clinical trials of interest, completing feasibility studies, satisfying regulatory requirements, good clinical practice (GCP) training, negotiating contracts, documentation, data entry, learning and integrating technology solutions mandated by the sponsor or CRO, and more.
A recent survey by CenterWatch suggests sites are overwhelmed with mandated technology solutions that do not communicate well with each other, reducing operational efficiencies and adding to an already heavy workload.
Another factor driving an increased workload at sites is increasing complexity of clinical trial protocols. A recent study by the Tufts Center for the Study of Drug Development showed a dramatic increase in both the mean number of distinct procedures carried out per protocol and the frequency with which each distinct procedure was performed over the last decade. Increasing protocol complexity makes the patient-facing work that sites are responsible for more difficult. Not only is the average patient visit growing longer, but protocol complexity also contributes to increased difficulties in patient recruitment at sites.
Unfortunately, site budgets are not keeping pace with this increased workload. Complex payment and reimbursement processes utilized by sponsors and CROs often result in inaccurate and late payments to sites. A 2009 CenterWatch survey indicated slow payments and reimbursements was sites' top operating concern. A follow-up study in 2012 revealed the extent of the payment delay issue:
- 37 percent of North American sites wait more than 90 days for payment
- 42 percent of European sites wait more than 90 days for payment
Slow payments place an enormous burden on sites engaged in clinical trials.
Payment Issues at Investigative Sites
Sites have many short-term financial obligations - employee payroll is typically paid biweekly, utilities and rent are due monthly, study volunteers are typically paid at each visit, and vendor terms are monthly. In contrast, payment terms from sponsors and CROs are typically quarterly or longer, which creates cash flow problems at sites.
According to Christine Pierre, President of the Society for Clinical Research Sites (SCRS), "Quarterly payments mean that the sites are paid at about five and a half months to six months from when they deliver the service." As William Dirkes, President and Chief Research Officer of Sentral Clinical Research Services, says, "Right now, because of slow payment terms, I'm funding some studies out of my personal savings or using a credit card. I don't think I could get a line of credit because our site is too new."
The main driver behind slow payments is outdated, manual payment procedures. The current processes utilized by many sponsors and CROs largely reflects a time when AMCs were the predominant site for clinical trials and data was collected manually. Before making a payment, sponsors and CROs had to follow a cumbersome, manual process that involved sending monitors to sites to review data to determine whether a site had met their contractual obligations. Personnel at these sites were paid by the university, and there was little incentive to process timely payments or for sites to request faster payments.
Many sponsors and CROs have not updated their payment systems to reflect the digital age and still use these outdated methods. "We are moving forward with efforts to have data extracted from electronic health records and directly transported into EDC (electronic data capture) systems," says Pierre. "But we are still holding onto legacy payment models akin to how we managed data 20 years ago."
These legacy, manual payment processes create a number of other problems for sites:
- Manual payments are error-prone.
- Payments often do not contain documentation about what the payment is for, making it difficult for sites to track whether they are being compensated appropriately.
- Sites don't have any visibility into when their payments will arrive, making it difficult to plan and execute efficient operational procedures.
- End-of-study reconciliations can be lengthy and contentious.
- Site personnel are distracted by both payment and patient reimbursement tracking, diverting their attention from important study-related duties.
- Many sites still receive payments via check (as opposed to electronic funds transfer (EFT)), which site staff must process.
Data from a recent survey by Greenphire and SCRS supports the idea that it's time for a change: 63 percent of sites prefer electronic payments, 84 percent want to be paid in 30 days or less, 44 percent employ personnel with study-related duties who also help with accounting, and 74 percent report study personnel spend more than 15 minutes per patient visit on accounting activities.
Impact on Sponsors and CROs
According to a payment survey conducted in March 2016 by Greenphire, more than 60 percent of respondent sites polled in the U.S. received their reimbursements quarterly, and 59 percent indicated quarterly payments impact their clinical trial. Research conducted by the Clinical Trials Transformation Initiative (CTTI) revealed that lengthy delays in payment to sites result in high turnover rates among clinical investigators, with 40 percent of sites dropping out of clinical trials regulated by the FDA.
Because sites represent the backbone of clinical trials, anything that affects them negatively has a detrimental effect on studies. Problems created in clinical trials by legacy payment processes include:
- increased duration of trials - site personnel are diverted from study-related duties into accounting activities
- increased cost for sponsors and CROs - sites that drop out are expensive to replace, and slowed timelines at sites drive up trial costs
- decreased trial quality - lack of timely payments with good documentation can lower morale of site personnel and result in poor site engagement and performance.
Given the intensive focus on the need to reduce timelines and costs while boosting quality in clinical trials, outdated payment processes clearly need to be addressed. Sites, for their part, are becoming increasingly selective about whom they choose to do business with. Sponsors and CROs that pay their sites correctly and in a timely fashion have a significant competitive advantage in securing quality, experienced sites.
Implementing Automatic Payments
Fortunately, the industry is beginning to address this issue. In 2016, SCRS initiated the site payment initiative, which is being co-led by Novartis, INC Research, and SCRS. The purpose of this initiative is to establish an industry standard for the frequency and process of how sites receive payments for work related to industry-sponsored clinical research.
While many sponsors and CROs recognize that changes are needed to payment systems, much inertia exists due to the massive accounting effort and staffing increases that would be required to switch to monthly payments. Many companies have inflexible internal business systems across the enterprise, which makes it very difficult for them to provide monthly payments to sites that request it.
However, some companies are undertaking the massive IT effort required to customize their internal systems to provide for shorter payment terms. Clare Grace, senior director of site and patient recruitment at Pharmaceutical Product Development (PPD) says, "We are moving toward having our EDC and clinical trial management systems (CTMS) talk so we can automatically cut a check to the sites. This will speed up payment, but it takes a lot of technology to get there. At the same time, we want to take into account our clients' wishes in order to put all the pieces in place."
Fortunately, financial-niche solutions providers have emerged that make the transition to shorter payment terms more reasonable. With e-clinical systems already in use within many of today's clinical trials, organizations can easily shed their old manual payment systems that are tied to monitoring visits. EDC and remote monitoring systems allow sponsors and CROs to track clinical trial activities in real-time. This data can be exported to a cloud-based automated payment system, where site activities are matched with contractual terms and milestones to determine whether a payment is triggered.
This provides a number of important benefits to sites, sponsors, and CROs such as:
- Quicker response time from vendors to accommodate regulatory changes.
- Faster and more accurate data-driven processes and payments (monthly payment schedules).
- Reduced monetary issues allows site personnel to concentrate on the study, participants, and tasks at hand.
- Improved visibility into payments and future payment forecasts and trends for all stakeholders.
- The ability to support flexible, custom contract terms.
- Faster payment corrections when EDC data results are corrected.
- Decreased payment-related activities, which frees trial monitors to focus on core tasks.
- Better cash flow, less stress, and higher productivity for everyone involved.
- Increased control over study cashflows, improved operational efficiencies, and better compliance.
- The ability to offer predictable and scalable service offering.
Sponsors and CROs with the foresight to adopt these cutting-edge payment technologies are becoming partners of choice for high-performing sites. Given the current shortage of sites, adoption of these technologies is a high priority for all forward-thinking sponsors and CROs.
Delays in site payments ultimately impede critical aspects of clinical research, including retention of both investigators and sites. As an industry, it is imperative to find automated, transparent solutions and leverage the existing digital infrastructure to streamline process payments to sites. Ultimately, practical solutions require a concerted effort and collaboration among sponsors, CROs, sites, and technology vendors. Solving site payment issues will improve the working relationship with sites. In turn, investigator turnover and site engagement will improve, driving quality, reducing clinical research delays, and delivering a better experience for patients.
Oracle Health Sciences
Jae Chung is the founding visionary of goBalto, the industry leader in study startup. goBalto's SaaS platform offers the only complete end-to-end platform for starting clinical trials, from site identification, feasibility assessment and selection through to activation, with comprehensive metrics to track adherence to timelines and budget. In October 2018, Jae lead a successful merger and acquisition of goBalto with Oracle Health Sciences. A startup evangelist, Jae works with Rock Health to mentor healthcare technology startups. Jae previously co-founded Celltrion (068270:KOSDAQ), a leading biopharmaceutical manufacturing company and was a strategy consultant with McKinsey & Company. In 2013 he was recognized as a FierceBiotechIT Top-10 Techie list and in 2010 was awarded the Bio-IT World Judges Prize for Technology Innovation. Jae holds an MBA from New York University and is a CPA.
Article published in Clinical Leader, January 2018