5 Tips for Effective Budget Negotiations

Negotiating clinical trial budgets is often a lengthy back-and-forth process between the institution and sponsor/CRO. Consequently, this process can greatly delay study start-up. Here are five tips for more effective and efficient budget negotiations:

  1. Prioritize negotiations on non-negotiable items. Focus your negotiation efforts on institutional budget requirements and patient care items that will not be covered by the patient’s insurance. A common non-negotiable item is study start-up. Many institutions have a threshold dollar amount for start-up that must be obtained to move forward with the study. For this reason, focus heavily on negotiating for the full start-up amount. This may mean not spending as much time negotiating other fees like IND safety reports. It is also important to focus on items not covered by the patient’s insurance. For example, if an angiogram is non-covered in the study situation, focus the per-patient budget negotiations on making sure the angiogram is covered by the sponsor.
  2. Use the coverage analysis as a negotiating tool. Institutions and sponsors typically differ in their interpretation of items that are billable to the patient. If the institution determines that most items cannot be billed to the patient in the coverage analysis, this has a significant impact on the budget. It’s possible that the per-patient total could double or even triple because of different interpretations of standard of care. Most sponsors and CROs will ask why the item cannot be billed to the patient. Reference the coverage analysis when explaining why the item needs to be sponsor-paid. The argument used for why the item is not billed to the patient can also be used as a negotiation argument. Quoting limiting Medicare rules always makes a strong case for why the sponsor should cover the cost of the item.
  3.  Show a sense of urgency when you work with the sponsor or CRO. If they know that you are motivated to the get the budget negotiations done quickly, then they are more likely to respond faster and help you expedite the process. Communicate your timelines with the sponsor or CRO right away. If they do not expect the negotiations can be completed in that timeframe, then this can be communicated to others working on other areas of study start-up. Following up with the sponsor regularly also shows a sense of urgency. Check in with them at least once a week, and respond to edits as quickly as possible. If there are significant edits, it is a good idea to pick up the phone and talk through the edits, which leads into my next tip. . .
  4. Call the sponsor or CRO. Writing out explanations via email can take hours depending on the number of edits. The same edits can usually be discussed within a half hour over the phone. It is not uncommon for more than one person at the institution and sponsor or CRO to review the budget edits. By having a phone call, everyone who is involved in the budget negotiations can be present. This often prevents double review by both parties. After the phone call, it is important to follow-up with the sponsor or CRO via email to document items that were discussed, especially if you agreed to keep certain fees in the budget or agreed on a dollar amount.
  5. Have fee documentation ready. Many sponsors will request letterhead documentation for site fees, especially administrative fees. It can be beneficial to develop a documentation template that can be used across multiple studies. You may need more than one template if different departments have different fees and others have separate templates for observational and interventional studies. Having a standard documentation form is a major efficiency and helps make sure costs are covered. If you save the documentation as a PDF that can be sent with every budget, you no longer need to re-write the fees and justification for every study. Documentation is also frequently required for the sponsor to cover certain fees or dollars amount.

After negotiations have been finalized and the budget is ready to go into the contract, complete a careful review of the budget. Make sure the payment terms were reviewed, the billing designations match the coverage analysis, and that all your edits were incorporated. Typically, budget negotiations have several comments and edits, so they can look pretty messy by the time you finish negotiating. Review the cleaned-up version closely to make sure all the changes were incorporated. Once this is complete, you are ready to finalize the budget.

NCI Accreditation 101

The National Cancer Institute (NCI) Cancer Centers Program, which is responsible accrediting high performance cancer centers, is a leading voice in the nation’s cancer research effort. There are currently sixty-nine NCI-Designated Cancer Centers that form the nexus of the NCI’s initiatives for studying and combatting cancer.  While there are many cancer centers in existence, becoming NCI-accredited is one of the most rigorous and prestigious designations in the country.

History of the NCI Cancer Centers Program

In the early 20th century, cancer was considered a mysterious and pervasive disease. Great minds became attracted to the prospect of conquering the unknown, and with new technology available to them, a handful of laboratories grew to become a network of universities, hospitals and institutions. Physicians and scientists from overarching interdisciplinary projects began collaborating to drive innovation in cancer research.

In 1930, Congress passed the Ransdell Act that created the National Institutes of Health (NIH). This legislation marked a change in attitude of the scientific community toward public funding of medical research. Just five years later, the NCI was created as a part of the NIH with full support from every senator in Congress. This unanimous front against cancer revealed growing concern over the invasive disease. Shortly thereafter, a number of governmental grants started a snowball effect in the cancer research community, producing a number of discoveries and treatments.

The NCI’s role has evolved from authorizing grants for research to encompassing all aspects of cancer awareness and treatment. The NCI has also cultivated an environment in which top-tier cancer research institutions can be recognized, supported and funded. In 1967, eight cancer centers were the first to receive research support from the NCI. Soon after, the NCI established the notion for accreditation based on the criteria set forth by the National Cancer Advisory Board. Over time this evolved into a set of guidelines and requirements that the NCI uses to accredit designated cancer centers today.

NCI Accreditation Today

NCI cancer centers are most often affiliated with university medical centers, though some are stand-alone institutions. NCI-Designated Cancer Centers all focus on some combination of laboratory research (cells or animals), population science (large groups of people) and clinical research (testing treatments on volunteers or patients).

Currently, there are three designations recognized by the NCI:

  • Basic Laboratory Cancer Centers conduct only laboratory research and do not provide patient treatment.
  • Cancer Centers are recognized for their scientific leadership, resources, and the depth and breadth of their research in basic, clinical and/or population science.
  • Comprehensive Cancer Centers hold the most rigorous designation. These centers demonstrate an added depth and breadth of research, as well as substantial transdisciplinary research that bridges these scientific areas. Institutions must pass a thorough review to receive this designation.

Achieving NCI Accreditation

In order to achieve NCI-designation, a cancer center must prove itself capable of making significant strides against cancer, as well as act as a hub of ground-breaking treatments and care for the community. Though there isn’t a specific set of standards that an institution must follow, the review process for achieving the designation is regarded as extremely rigorous.

Although NCI-Designated Cancer Centers have greater responsibility to serve their surrounding communities, the benefits are also significant. According to the NCI, funding “supports shared research resources, provides developmental funds to advance scientific goals, and fosters cancer programs that draw investigators from different disciplines together.” Further, for the select few able to attain the NCI designation, the revenue implications are substantial—millions of dollars in funding for research infrastructure allows these institutions to attract patients and top investigators.


Above all, the NCI Cancer Centers Program serves as one of the anchors in the nation’s cancer research effort. With the help of NCI grants, hundreds of research studies are underway at any given time, from basic laboratory research to assessments of revolutionary cancer therapies. The rapid pace at which NCI-Designated Cancer Centers are discovering new treatments has translated into improved cancer diagnosis and treatments across the world.






Budgeting for Clinical Trials 101

Developing an internal budget can be a complex process, but it’s important for many reasons. First, the internal budget allows the research office to see the actual cost to conduct a study. Additionally, the internal budget is often more detailed than the budget provided by the sponsor. Your internal budget might vary from other institutions due to specific processes, and it can be built in an excel document or directly into a CTMS. Developing an internal budget allows for additional comments and clarifications that may not be possible to add to the sponsor’s template. Lastly, an internal budget can be formatted to meet any specific internal needs. A good example of this might be including specific formulas to account for how much money should be allocated to the PI, the nurse or coordinator, or to cover various departmental fees.

Subject Injury Language: What You Need to Know

One of the negative aspects of clinical trials is the possibility that a patient will suffer an injury or illness as a result of their study participation. As such, one of the most important pieces of a contract is the subject injury language. ‘Subject Injury’ is defined as an injury, illness, adverse event/reaction, or death caused by a study subject’s involvement in a clinical research study. Prior to the study, the research site and the study sponsor should come to an agreement on what exactly constitutes a Subject Injury, and who pays in the event of a Subject Injury.

Four Common Oversights of Investigator Initiated Trials

Within the past two years, investigator initiated trials (IITs) have seen a remarkable renewed interest. While research offices are doing their best to support these endeavors, the additional administrative responsibilities involved are often unfamiliar to research offices. Consequently, mistakes made during the initial development and start-up stages can cause compliance and financial ramifications. Here are four common mistakes to look out for when conducting an IIT study:

HIPAA: Reflecting on the Past and Preparing for the Future

When the Health Insurance Portability and Accountability Act (HIPAA) went into effect over 10 years ago, it was met with great apprehension and concern from those in the healthcare industry. Today, it is one of the most important legal and ethical guidelines in the industry. How has HIPAA evolved since its inception? Let’s step back to examine a few key points in its development.

NCDs and LCDs 101

National and Local Coverage Determinations (NCDs and LCDs) are two of the most important aspects of Medicare coverage. Both NCDs and LCDs are released by Centers for Medicare and Medicaid Services (CMS) to standardize Medicare coverage for certain medical tests and procedures. These determinations outline the conditions in which a service is considered to be covered by Medicare.

Are Small, Independent Research Sites Going the Way of the Dinosaur?

Much has been written about the changing clinical research landscape, and more importantly, the implications these changes are having on small, independent research sites. The first major change was the implementation of preferred site programs by many larger contract research organizations (CROs). The second, and more recent development, is the actual acquisition of research sites and site networks by CROs. Separate of both of these trends, is the premise that “big data” will give larger health systems a competitive advantage, allowing them to reestablish their dominance in Phase II and III research. Each of these themes are explored in greater detail below.

6 Things to Consider When Performing a Coverage Analysis

Developing a coverage analysis (CA) can be a very tricky task, especially for a novice analyst. Nonetheless, it is crucial to conduct CAs in order to ensure billing compliance. There are several important items that need to be considered while building a CA. This list is not meant to focus on every single one of these items, but to highlight a few important items that should be considered while building a CA.