Risk share by definition means that each party puts something at risk. Oftentimes in the life-science industry there is one-sided risk and not a lot of sharing. Many companies try and establish standardized processes for risk sharing just to find out that study-specific nuances prevent this from happening.

Each study is truly unique in its design and the way it’s operationalized at the site level. Some studies lend themselves to risk share being evaluated on screened patients, while others lend themselves to a referral evaluation. A risk-share program based on randomized patients is very challenging and opens a lot of speculation. It is the research center’s responsibility to enroll a patient into a trial, not the recruitment vendor’s responsibility.

When developing a risk-share program, consider mutual key performance indicators (KPIs). Ensure all required parties agree to these KPIs being listed in the contract. And be aware of evaluation challenges that may be unforeseen. For example, determining the appropriate tracking mechanism can be difficult.

In a recent global relapsing-remitting multiple sclerosis study, we decided to use the established IVR system to track during the screening visit how an individual learned about the study. We agreed on the prompt definitions describing the various sources of referral. Training was conducted with the sites on how to mark the appropriate prompts within the system.

Our risk share was based on screened patients who were attributable to Imperial. At an interim evaluation of the data, we had achieved 30 percent of our target. But upon further analysis, we noticed that some of the recorded prompts were incorrect because, for example, we hadn’t initiated a specific service yet. Therefore, an unplanned detailed analysis had to take place, resulting in us only achieving 21 percent of our goal, which represented a 46 percent decrease from the initial analysis.

These findings resulted in several observations: (1) despite proper training there still was inaccurate reporting in the IVR system; (2) we needed to reassess how to accurately track the impact of our strategies; and (3) we had to revise the existing risk-share agreement.

So just keep in mind that desired risk-share agreements may be limited or become null and void if KPIs are not met.