Elevating Clinical Research Site Relationships With New Budget and Payment Paradigms

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In the current clinical trial landscape, sponsors and contract research organizations (CROs) are carefully considering how they can improve their relationships with clinical research sites. Elevating site support with comprehensive budgets and accelerated site payments has emerged as a key strategy in this effort.

It is in the best interests of sponsors and CROs to pursue these improvements for many reasons, but chief among them is that the demand for research sites is growing, while the supply is failing to keep up. Clinical trials are expected to grow over 7% year over year to keep pace with growing patient populations,¹ but new site entries into the market are slowing. Even when new investigators attempt to enter the clinical trial market, 20% drop out after only one trial.²

Meanwhile, protocols are getting more complicated,³ and a combination of technological and regulatory forces is putting additional pressure on sites’ time. For example, many sites fear a significant increase in time is needed to adopt decentralized trial technologies, and nearly 70% of sites feel they are insufficiently supported to recruit in accordance with diversity guidance from regulatory agencies, sponsors and CROs.⁴ In the US, the FDA has published several new guidances on increasing patient diversity in clinical trials, making trial participation more convenient via digital health technologies and home health care solutions, and making better use of real-world evidence. However, migration to decentralized trials requires additional skills and training of site personnel who have historically interacted with patients in person.

On another front, financial pressures are a key factor forcing many sites out of clinical trials and keeping new entrants from replacing them. Site payments are often subject to prolonged payment terms of up to 90 days from receipt of a correct invoice and sometimes including holdback provisions that stretch the time to receive compensation for work performed. As a result of this long payment cycle, a recent landscape survey conducted by the Society for Clinical Research Sites (SCRS) found that 80% of sites had six or fewer months of operating cash on hand.⁵

Sites often find “fair market value” discussions opaque and are challenged to anticipate the time they may need to expend recruiting patients, dealing with complicated systems and responding to frequent protocol changes. And over 80% of site representatives say they are negatively impacted by site payment delays.⁵ In other words, overdue payments impact their openness and ability to participate in clinical studies. Ensuring that sites are paid quickly and accurately for all work required by the protocol is essential for sponsors and CROs to ensure that there are sites available and willing to conduct their trials.

However, improving site payments processes can be extremely difficult when relying upon outdated paradigms. The payment schedules negotiated in existing site contracts often require validation of completed site activities that is labor-intensive and leads to delays in issuance of payments. Budgets drafted at the procedural level for complicated protocols may generate tens of thousands of lines of payment for even a medium-sized enrollment trial. Complex country requirements, such as split payments, also complicate payment operations. The result is that today, 23% of clinical research sites report experiencing payment delays of 90 days or longer.⁵ Accounts receivable collection periods increase these delays even further when applying account holdbacks that may take a site years to collect.⁶ These outdated paradigms risk damaging site relationships and making it impractical for sites to participate in needed studies.

Fortunately, an increased focus on the costs borne by sites is helping to provide better budgetary support. Sponsors and CROs are becoming more flexible in response to site requests during budget negotiations, especially where sites can provide documentation and/or evidence of actual time or money spent on a task related to the study. Many are considering including budget line items that cover time spent on reviewing protocols for recommendations on how to attract diverse patient populations or on setting up and utilizing new trial technology. Compensating sites for their time learning and using effective technological solutions may help them get beyond the “adoption curve” that slows down or blocks many potential time-saving tools. Meanwhile, some sites and site support groups such as SCRS are working to identify "hidden” costs and trial efforts that sites may not anticipate before negotiations, looking to help sites with less experience in clinical trials and/or within a particular therapeutic area.

Additionally, a new payment paradigm is emerging that offers relief to sites, as well as the sponsors and CROs who are paying them. The framework of this paradigm is based on reducing the lines of payment and automating much of the validation of payment activities. This can be achieved through a mixture of careful budget setup, minimizing the number of invoices required, and the use of external sources of data such as electronic data capture (EDC) to validate site activities. Implementing this paradigm allows shorter payment terms and lowers the administrative burden on sites, sponsors and CROs. Faster and more accurate payments will make sponsors and CROs preferred partners for valued sites, and support the entry and retention of more sites into the clinical trial space.

Sponsors who want to work in this paradigm should ask the following questions when setting up their payments for a trial or considering a CRO partner:

• How will the study budget be negotiated and structured?
  • Sponsors and sites both tend to prefer to negotiate by procedure, to ensure accurate capture of site costs, but paying by visit will reduce administrative time spent before payment. An ideal approach negotiates by procedure and then pays by visit.
  • Consider whether patient reimbursements can be managed as pass-through costs that minimize the administrative burden on the sponsor or CRO and the tax burden on the patient.
  • Set up budget parameters for negotiators that take into account cost drivers that may apply to potential sites, including location and the inflation environment.
• Are there any costs that sites may incur that are not on the schedule of events, but should be included in the budget?
  • Consider any extra time needed to learn and use specific technology. Anticipating these costs accelerates negotiations, improves site satisfaction and makes grant forecasts more accurate.
  • Consider whether additional time should be added to allow sites to enable strategies for recruiting patient populations that align with diversity goals.
• What are the payment triggers and how do they align with available data sources (e.g., EDC)?
  • Ensuring that triggers align with available data sources allows for automation and reduces the burden of site or clinical monitor administrative activity.
• Are there any items that can be moved from an invoiceable cost to an automated item?
  • Moving costs from invoiceable items to those triggered by an automated data source makes payments quicker, easier and more accurate for both the site and payment staff.
• ·What are the payment terms? Will there be withholding?
  • Budgets set up in this new paradigm can support shorter payment terms than were required by prior paradigms, which often stretched to 90-day terms. Additionally, many sites are pushing back on withholding.
  • If utilizing a CRO to make study payments, consider whether funding terms in the services agreement are sufficient to keep up with the expected rate of payments.

This new paradigm for site payments offers a path for sponsors to improve their relationships with sites and help both new entrants and existing sites continue in key clinical trials. Fortunately for all concerned, it is a paradigm that can be adopted at the start of the next protocol.

William Garton, Senior Director, Site Contracts and Payments, PPD clinical research business of Thermo Fisher Scientific

References

1. Clinical Trials Market (By Phase: Phase I, Phase II, Phase III, Phase IV; By Study Design; By Indication; By Sponsors; By Service Type) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033. Vision Research Reports. 2023. https://www.visionresearchreports.com/clinical-trials-market/38176’
2. Harold E. Glass, Andy Guy, Who Are the Active U.S. Principal Investigators? Clinical Research. 10-December-2022. https://acrpnet.org/2022/12/20/who-are-the-active-u-s-principal-investigators
3. Nigel Market, Ben Howitt, Ilyass El-Mansour, Carel Schwartzenberg, Olga Kotova, Christoph Meier. Clinical trials are becoming more complex: a machine learning analysis of data from over 16,000 trials. Scientific Reports. 12-February-2024. https://www.nature.com/articles/s41598-024-53211-z
4. Kim Boericke, Tanya Kogan. Driving Diversity in Clinical Research. Pharmaceutical Market Europe. May 2024. https://pme.pmlive.com/collections/4c746981-12bc-11ef-84d3-42010a800015/4e5b20e3-12bc-11ef-84d3-42010a800015
5. The 2023 Site Landscape Survey, Society for Clinical Research Sites, https://myscrs.org/download/2023-site-landscape-survey-white-paper/?tmstv=1732045361
6. Norman M. Goldfarb. Operating a Clinical Research Stite in the Age of High Interest Rates. Applied Clinical Trials. 27-October-2023. https://www.appliedclinicaltrialsonline.com/view/operating-a-clinical-research-site-in-the-age-of-high-interest-rates