Clinical Site Budgets

Negotiating Clinical Trial Site Budgets for the Schedule of Assessments, one-time fees, and pass-throughs
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Money Matters: Today is payday, so this topic falls under the theme of trial fiscal management. Like a steady paycheck, you can look for blog updates on financial topics in this semi-monthly series.
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Debits, and Credits, and Finance, oh my! Clinical Site Budgets

Negotiating Clinical Site Budgets

For today’s installment, let’s chat about a few clinical site budget topics. In my role, I’m asked to balance the responsibility of being frugal with the practical concern of getting budgets finalized expeditiously to move sites along in the start-up process. My management team requests accurate forecasting of planned study expenses so this budget process is an important time to suss out any faulty or hidden assumptions and limit uncontrolled cost drivers.

Standard Line Items in Clinical Site Budgets

For sure, you want to reimburse each site roughly the same amount per procedure. Using a budget template makes this a breeze. However, site personnel will want to negotiate certain items and if they say an ECG is $100 a unit and you are typically only reimbursing $50 a unit, you’re at a bit of an impasse. From here you could offer to split the different or look at the total budget and decide if this is an item you can just let go. Maybe you only do one or two ECGs in your trial anyway, so letting $50 – $100 go over the course of conduct may make sense when considering the cost of a trial as opposed to the cost of goodwill lost over splitting hairs. Possibly, their total per patient fee is low enough anyway that you can tolerate this excess against the average.

On the one hand, you do want to pay in accordance with normal and customary charges and make sure you are getting a fair deal. On the other, penny-pinching is rarely worth sacrificing good relationships with site staff. However, it is helpful to remember that you may not have to work with this contract person again after the budget is finalized so maybe you can campaign a bit harder on the small stuff. Just tread carefully here; if you pummel a site during budget negotiation and they are so turned off that when it is time to enroll they aren’t enthusiastic about your trial, does your hard negotiation really buy you anything?

Schedule of Assessments (SOA) Mismatch

Verify that there is no mismatch with the schedule of assessments. Commonly sites will leave out budget units for Unscheduled assessments. Frequently, a site will budget for assessments that are standard of care and not necessarily required per protocol or the SOA. Rather than itemizing these, it may be more appropriate to just include them in an overhead category for easier invoice reconciliation later. Again, ensure that the items are reasonable, appropriate, and in accordance with the budgets from other sites in the trial.

Little Extras

I’m always on the look out for non-standard line items, or extra per patient or one-time charges that have been slipped-in to a budget draft. Some examples include start-up fees, pharmacy fees, shipping and administrative fees, extra data entry fees budgeted per SAE, study coordinator fees, excessive query fees, etc. In most cases, I can accept these charges if they are refundable upon non-performance, reasonable and specific, and/or the site can provide past performance data to support the extra charge; i.e. can they “put their money where their mouth is.”

Why should I pay a premium in a clinical site budget?

Where possible, avoid shelling out big bucks for all your sites but you will need to give leeway with more experienced sites that better understand the costs of clinical trials; chances are they are they are more likely to be able to justify the real expenses as well. If you are budgeting more to include some academic institutions or KOLs that may just be a cost of doing business. In the end, you can find that these institutions have higher per patient fees but actually cost you less overall or the expenses are acceptable.

At the end of every trial, it behooves you to prepare a metric of budgets vs. actuals. Add up 1) actual per-subject fees paid (Screen Failure & Enrolled) 2) start-up fees 3) other administrative or one time fees and then calculate the average cost per subject-randomized. Once you blow away some of the assumptions your management team made in this round of budget negotiations (high per-patient fee = better quality; sites with high start-up fees always end up costing more in the end; sites with low per-patient fees cost less (maybe not!); etc. – for all of these, not necessarily so – a future blog topic…), you’ll have an easier time dispelling their concerns for future trials (hopefully!).

Don’t pay for data you can’t analyze

Don’t pay for data that doesn’t help you evaluate your drug or device. The true cost of a screen fail only begins to be measured by combining the actual expense of subject reimbursement, site reimbursement, monitoring time to review that subject, data-entry time, analysis time, etc. Try to limit payments of Screen Failures. Most sites will accept a ratio payment; i.e. I’ll pay you for 3 SF for every 1 enrolled subject.

Have any of you had success negotiating a refund clause? I’d love to hear if it is possible to hold-back 20-30% of the contract until after analysis and refuse payment for subjects that were not evaluable.

Short and sweet

Don’t draw the budget negotiation out through multiple rounds if you can avoid it. Evaluate all the cost buckets and negotiate hard on the ones you can’t flex on but be willing to make some concessions on others. Site startup is always a critical time, and reducing the cycle time to complete a budget can have measurable payoff in the future. Give the process the time and attention it requires but know when to let it go and walk away; even if that means not moving forward with a site.

Your thoughts on clinical site budgets?

I look forward to returning to the topic of clinical site budgets again in future blog entries. In the meantime, I’d love to have your thoughts in the comments here or dialogue via email. Thanks for following along on my first post!

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About The Author

Nadia

Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.

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