I’m calling for a disruption of the current financial model in clinical research. I spoke about this topic at the December ExL 14th Clinical Performance Metrics Summit in Philadelphia. I will lay out exactly why a little disruption would be a good thing for everybody.
When sponsors hire sites, they are generally hiring them to do four things–enroll a certain number of agreed-upon subjects, produce the highest quality data possible, adhere to study timelines, and provide high-level customer service. However, the current system emphasizes enrollment over any other metric. This is evidenced by continuing to award studies to sites that are enrolling yet making mistakes and consistently falling short in other areas. This sends a clear message that enrollment is the only thing sponsors are paying sites to do. Financially, it disincentives sites from hiring staff or investing in technology to improve quality and adhering to timelines when those metrics aren’t tied to site contracts and budgets.
Sponsors view sites as commodities because they rarely do what they said they would, by when they said they would do it. Despite the emphasis on enrollment, only 40% of sites achieve their target enrollment goal. Nearly all studies go over their timelines taking 15 years to develop a product when it should take half that amount of time. Sponsors are having to pay CROs to find errors because most sites have poor quality data. With sites being undifferentiated, contracts are awarded to the cheapest. Pay models are considered physician compensation and don’t take into consideration what else sites are being paid to do. Sites are generally paid the same regardless of the quality of the data they are producing. In short, sites can make more money by serving their customer less.
We need disruption of the current financial model. Sponsors and sites need to mutually agree what quality metrics look like and how that can be measured. Sponsors can then differentiate above average sites as Premium Sites and compensate those sites for the resources being deployed to achieve their desired outcome. Fair market value isn’t the average budget of the average site but must be determined based on the characteristics, resources, and performance capabilities of each site. As any other vendor, compensation should be based on the skillset and results generated of each site.
If we are measuring target enrollment by a percent of attainment of the sponsor’s enrollment goal, then the current industry benchmark is forty percent. That means that right now 60% of sites never give you the enrollments they said they would. How much would sponsor costs go down if they knew their sites would hit their goals? If we measure quality data by measuring the major error rate as a percentage of total patient touches the goal is zero. What if, like IACT Health does, a site had its own internal Quality Assurance and Compliance Committee (QACC) that did the job sponsors are currently paying CROs to do by ensuring the site is producing quality data and sustaining a zero major error rate? What is the cost per day of trials failing to start and/or end on time due to site failures? What if sponsors knew a site’s percentage of achieving sponsor goal timelines? At IACT Health, our goal is to open a trial 90 days from mutual study award, but we’ve done it in 30 days in the past by employing a full-time regulatory and budget and legal staff to achieve the sponsor’s timeline goals.
What shouldn’t sponsors have to pay for? Customer service. This one is on the site. However, sponsors should still be able to look at a site’s customer service metrics to know what they’re getting. My suggestion? Measure the customer satisfaction rate via a Net Promotor Score (NPS). Let the sites interview the sponsors and be rated on a 1-10 scale and the sponsors can decide how sites measure up. This is ultimately the conversation we need to have. What do you, the sponsor, want? Let’s identify and compensate premium sites for the resources being deployed to meet sponsor goals every time. How much would your cost go down if you knew sites would meet their goals? How much is that worth to you?
“Jeff’s presentation and views were provocative from the sense that it will require sponsors and more specifically, finance managers, to change the way companies engage with sites.” –Armelde Pitre, Senior Director, Clinical Development Quality, Quality and Performance Risk Management, PFIZER