Believe it or not, a sponsor who pushes back on a site’s budget requests might be doing the site’s leaders a favor. “In some cases, it can show that the site has hidden inefficiencies that make it charge [above the going rate] for a trial or specific piece of a trial,” says Jennifer Goldfarb, MSN, RN, CCRP, senior director of the Clinical Research Support Office at Children’s Hospital of Philadelphia.
Example: A site in good conscience might seek $300 per blood draw as part of its budget request. Most sponsors would balk at that dollar figure. However, neither side is engaging in gamesmanship. Instead, the site has just learned through its budgeting that its costs are probably out of whack. “It might take them $300 per blood draw, but it probably shouldn’t,” Goldfarb says. Thus, “Budgeting presents an opportunity [for sites] to look at their own operational efficiencies.”
In addition, working up a study budget effectively should help the site identify questions its leaders need to ask the sponsor. “It’s not up to the sponsor to tell you what you need to do to get something done,” Goldfarb says.
Part of the challenge, Goldfarb adds, is that sponsors tend to want to make their budgets relatively simple and top-line. “They won’t list out what you need to do,” she says. It’s up to the site to dig deeper, identify what it will need to get the job done, and find ways to articulate that during the negotiation process.
“In my experience, if your request is reasonable and articulated, you’ll get it” from the sponsor, Goldfarb says. “You have to know how to ask and how to justify your costs.”
Returning to the example of the $300 blood draw, the sponsor is likely to view the site as being disorganized or otherwise not up to the task of a major study with that kind of price tag being placed on such a simple procedure.
“Despite our best efforts, site budgeting and financial planning remain problems,” Goldfarb stresses. “We still haven’t figured it all out.”
Author: Michael Causey