During a recent industry conference, I attended a daylong workshop on site management fundamentals. During this workshop, some of the presenters spoke about best practices for effectively building and overseeing a quality clinical research staff. Discussion surrounding this topic, in particular, revealed common struggles for members of site management teams. One workshop attendee ignited a discussion about her difficulties reasoning with Principal Investigators (PIs), particularly when they choose to take studies that may prove detrimental to a site’s finances.
The attendee asked, “How do you deal with a PI that insists on taking a study, even when you know that study will result in a loss?”
Other members of the group expressed mutual frustration when faced with this situation and some shared the arguments their PIs have used to justify taking potentially unprofitable studies. One common argument from PIs is that they “want to support science,” regardless of costs associated.
In response to the above question, the group brainstormed ways to counter these arguments from PIs, including:
Presenting statistics as a reality-check
One attendee stated that he gives his PI a hypothetical situation based on amounts pulled from previous studies to explain the significance of the site’s financial burden. He asks his PIs, “would you be willing to personally write a check to give this company $80,000 for the privilege of conducting the study?” In doing this, he hopes to reveal the strain the PI’s actions could place on the site. Additionally, this exercise could reveal how serious the PI is about the study and potentially lead to a larger discussion or further consideration.
Creating a metrics-driven policy
Another attendee suggested enforcing a policy that states a study cannot operate at a loss greater than a specified amount. This amount should be based on metrics-driven data from previous studies. Once created, the policy can then be used to deter studies that may incur a greater loss and provide fodder for discussions with the PI. An established policy could also prove helpful during budget negotiations, as it reveals a solid understanding of what is needed for optimal site performance and could act as support for any potential pushback from sponsors and CROs.
This discussion led to further dialog regarding when it is appropriate for a site to operate at a loss and how this affects the site’s reputation. The general consensus was that the only appropriate instance for a site to conduct studies at a loss is when it is new and trying to establish itself in the industry. New sites may wish to take these studies in order to form relationships with sponsors and CROs, and to gain valuable clinical research experience. However, in most circumstances, the study should support itself and the negotiated budget should cover all operational costs.
Easing the financial management burden
These dynamic workshop discussions both brought to light common concerns with communication among clinical research stakeholders, and highlighted how stressful financial management is for many research organizations.
Maintaining efficient and compliant financial practices across research operations is a significant concern for many, if not all, research organizations. During a 2017 survey of over 900 research professionals, Forte found ‘maintaining a positive cash flow’ was identified as one of the top three most challenging clinical research tasks. Many financial management problems at research institutions are caused by variable, un-mandated, or non-existent financial policies. Without effective, mandated financial workflows and processes, institutions run the risk of losing revenue, wasting time and facing regulatory repercussions.
During our our free, upcoming webinar, “Steps to Enhance Clinical Trial Financial Management at Your Research Institution” Bishoy Anastasi of the University of California, Los Angeles (UCLA) and David Goodrich of Indiana University (IU) will discuss how their respective organizations addressed common challenges in financial management processes. Join us for this presentation to hear real experiences from two prestigious research institutions and gain tangible takeaways to help you enhance your clinical trial operations. Register today to save your seat.