Time and effort have their own value and should be budgeted and billed for just as more tangible costs — tests, patient visits, trial supplies, etc. — are, say budgeting and contracting experts who warn sites about letting these intangibles slip through cracks in their systems.

“Sites often don’t spend the time tracking all of this activity, so it’s easy for them to lose sight of the time and effort they are putting in to support the clinical trial,” John Ntambi, manager of clinical research administration for WCG, told CenterWatch Weekly. “And even for sites that have a good understanding of this time, it can be a challenge to then convince the sponsors to cover the full cost.”

Because it’s uncommon for sponsors to account for these types of costs themselves, it is critical that sites are on top of them. In the experience of Raechel DeFabio, senior clinical research analyst for WCG, sponsor protocol and budget templates typically don’t list such things as coordinator time for scheduling patients, time for creating protocol calendars in the clinical trial management system or investigator time spent reviewing/signing documents. Similarly, general ongoing administrative tasks, such as monitoring visits, safety report reviews and trial data management, are all tasks that require significant time and effort yet may not make it into budgets.

Joshua Rowell, senior director and head of global site contracts for Syneos Health, has found that the “hidden costs” most commonly missed by sites involve training for sponsor systems/using several systems in parallel, coordinator time needed to support patients with decentralized trial methodologies and time spent helping patients with trial systems or devices. “We hear a lot of sites talk about how much time they spend on the phone with a patient,” he notes.

From his CRO perch, he’s also observed that sites can have a hard time keeping up with the number of clinical procedures they perform that are not automatically captured and paid based on visits performed. For activities such as these and many more, it ultimately falls on the site to push for their coverage by the sponsor.

He recommends sites consider their nonclinical costs and put considerable thought into the overall effort they will spend managing a study from an operational standpoint. How much study coordinator and investigator time will it take to work in sponsor systems and support patients on the study journey outside of clinic visits? What resources does the site need to utilize to enroll and find evaluable patients?

“This can be difficult to assess, but surely all sites spend considerable time on these elements,” he says. “When working with CROs and sponsors on budgets, [sites] need to be able to not only ask for this compensation but to clearly articulate why it’s needed and how they have calculated their cost.”

WCG recommends sites carefully and thoroughly review their processes, including study startup, to analyze and identify these resource-intensive tasks, and have standard fee schedules and documented justifications for their costs established before negotiations begin. Standard fee schedules should include:

• Time and effort costs, including hourly rates for study staff and baseline time estimates for common trial activities;
• Patient care costs, including single, research-specific or multiple chargemasters, clear Medicare pricing documentation, vendor rates for routine outside services, and bottom-line and negotiation thresholds for items under the fee schedule; and
• Administrative costs, including standard fee schedules for each department (as applicable), study-level internal site fees and fees that aren’t open to negotiation.

Having cost justification is hugely important, DeFabio says, as sponsors will frequently have standard operating procedures and processes that don’t allow them to pay beyond a certain amount without further site documentation.

“Sponsors are worried about complying with fair market value regulations and often will not go outside of a specific range without justification,” she says. “We find that the justification doesn’t often need to be overly complex. It just needs to be consistent, explain the background for each fee and reiterate that it is standardly charged in the same manner to all industry sponsors when applicable.”

Don’t feel pressured to give in when a sponsor or CRO is proving difficult to convince, either. It’s common for primary contacts to have certain parameters for budget negotiations that mandate escalation and review for anything outside them, a process that can take time, muddy the waters and make budget requests unclear, says Jenny Syburg, manager of clinical research administration for WCG. For the fastest decision-making, find the person who can get things done at the sponsor/CRO, hold a phone call or virtual meeting with them and give them the
full story — don’t try to explain things in an email.

“We often find that sponsor/CRO contacts are reasonable when presented with the full context,” says Syburg. “This is especially true when talking to someone, which is why we often try to push for a conversation vs. handling everything by email when there are sticking points holding up the conversation. Directly speaking with the decision-maker will often lead to faster approval.”

It’s also important not to make a habit of giving in immediately — stand your ground to a point, Syburg advises. Sponsors are likely to take note of sites that regularly give in to them on budget requests off the bat and they will regularly cite precedent from previous trials, she cautions.

“Accepting something on one trial may make it harder to negotiate more for the same item on subsequent trials with the same sponsor,” she cautions. “Standing your ground does not have to equate to dragging out the negotiation over a protracted timeline.”

There are resources out there to assist sites on the budget negotiation process, the most recent of which is a site invoicing toolkit designed by the Society for Clinical Research Sites (SCRS). The resource offers sites an in-depth list of common invoiceable items that should be considered for inclusion in discussions with sponsors and CROs. The lengthy 65-page document offers advice on calculating costs for billable items, fee descriptions and alternative ways to charge for activities, as well as important considerations to be aware of.

Jimmy Bechtel, SCRS’ vice president of site engagement, recommends users employ the guide “trial by trial and site by site” and keep in mind that not every billable item listed will be relevant.

“Take the time to recognize if the various items are indeed realized by your site and be prepared to use this resource to develop your own, individualized justification and process associated with negotiating reimbursement for your costs,” he told CenterWatch Weekly. “Cost analysis is key, and this resource should help with that process and subsequent negotiations.”

Brad Gruener, vice president of site services for WCG, believes such resources are a good place to start but recommends sites move with caution when considering billing per occurrence or per hour of time spent as the SCRS toolkit suggests for many invoiceable items. Billing with this level of frequency can leave the site having to deal with an overwhelming number of invoices, he cautions.

“It’s great to think of those details and try to budget for them,” he says. “In reality, many sites would struggle to actually track and bill for those items as the trial is happening.” Gruener says that “it is inevitable that we end up with at least a few invoiceable items like that, but many of our clients prefer we find ways to limit the number of different invoices they need to send. In those cases, we will still account for those types of costs but build them into other parts of the per-patient budget, startup fees or other ongoing maintenance fees that are paid at regular intervals.”