CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Barbara M. Bolten spoke with Liz Christianson, senior clinical research analyst at PFS Clinical. Liz specializes in budget development/negotiation, coverage analysis development and clinical trial financial management.

Q: What are some common problems in developing clinical trial protocols for investigator initiated trials (IITs)?

A: In IITs, developing a protocol is often new territory for both the principal investigator (PI) and the clinical research administration team. Around 85% of investigators have participated in only one clinical trial—typically industry sponsored—in their career, so developing a protocol is completely new territory for them. These PIs are often new to clinical research and looking to publish and establish credibility in a particular field. They are jumping in with very little knowledge of protocol development or research billing.

One of the biggest challenges administrators face with new PIs is that they are not familiar with the financial ramifications of how the protocol is written. When working with investigative sites, we analyze each item in a protocol to determine if a third party payer or insurance should be billed, or if that item should be negotiated into the sponsor budget. One of the first things we look at is the objective language, because it strongly defines whether the trial is interventional or observational. That distinction largely determines how we’re going to bill.

In an interventional trial, we’re determining what treatment patients will be given. In this case, we bill in compliance with clinical trial policy as set by the federal government, mostly Medicare, and by the institution. That restricts what can be billed, because we have to make pre-emptive billing determinations for all enrollees in order to be compliant. In an observational trial, we are not intervening in the patient’s line of care or randomizing; rather, we are simply collecting data based on medical practices that have been predetermined for the patient regardless of trial participation. In that case, we don’t need pre-emptive billing determinations for all enrollees, and we can bill more freely to insurance based on patient-specific decisions made at the time of care. 

Q: What areas of the protocol should investigators focus on to determine a compliant billing strategy? How does this strategy affect financial feasibility of the trial?

A: There are three areas that I recommend PIs and their administrative teams focus on when writing an IIT protocol. The first is objective language. As we have discussed, the objective statement must clearly define whether the protocol is interventional or observational.

The second focus should be the inclusion/exclusion criteria for the trial. In an observational study, the criteria should indicate that the patient’s treatment has already been prescribed and might reference previous diagnoses. When intervention is taking place, the inclusion/exclusion criteria would include medical criteria. Like the objective language, the inclusion/exclusion criteria have to be clear in order to make billing determinations and to formulate a compliant billing strategy.

The third area of focus is protocol event nomenclature. For example, in an observational study, a protocol item might be listed as “angiographic data from the stent placement,” which means looking at the patient’s record to observe what happened and collecting data from that procedure. In an interventional study, the schedule of events might have an item called “angiography,” which refers to the actual procedure. Entering the term “angiography” in the schedule of events for an observational study leaves room for questions. When using observational billing strategies, naming the item “angiographic data collection” would be more compliant.

Financial feasibility comes into play when we build a build a budget. We look at who the payer will be—whether an item will be billed to insurance, or whether it will be the responsibility of the financial sponsor.  When we are budget building and making agreements with outside parties, we account for items that we cannot bill to insurance. The billing capacity is different in an interventional trial than in an observational trial, so the budgets for those trials will be significantly different.

Q: What are some suggestions for success in terms of IIT protocol development?

A: I recommend administrators implement an educational process to help PIs understand the financial ramifications of protocol language before those PIs partake in clinical research. I also recommend tailoring protocol submission forms to include educational resources, such as examples or links to video explanations or help lines. For example, placing a link next to the input for protocol objective language can lead the PI to explanations and tips about their wording. The goal is to help PIs understand the financial and compliance ramifications of the protocol language they choose, to recognize when they need guidance and to feel comfortable asking for additional resources when needed. 

This article was reprinted from Volume 21, Issue 15, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »