Choosing the right investigators (site feasibility) for your clinical trial is arguably the most critical decision to ensure enrollment success. Although overwhelming, what can make it truly daunting is a lack of data. According to Tufts, nearly 50% of investigators fail to meet their enrollment targets and 11% of investigators fail to enroll a single patient. Even more alarming is the number of investigators available for participation — how does one choose the right investigators given there are somewhere between 250,000 to 500,000 investigators globally?
Site Feasibility – Why So Crucial
Why is it so crucial to choose the right investigators the first time? Because, over time, investigator relationship management is critical to a company’s financial success.
Take a typical Phase III trial with the following criteria:
- 200 sites in one Phase III trial
- 22 sites fail to enroll a patient
- (22 sites) x ($25K to activate site) = $550K
The initial outlay to activate sites (and $550K is a conservative number) is just the start. It does not even consider other costs, such as adding more sites, time spent with the site, advertising to overcome low enrolling sites, etc. And this is only for one trial.
Also, consider the broader, long-term perspective. You need to consider costs for every day a drug is delayed. It’s widely accepted a pharmaceutical company loses $1M in revenue for each day lost.
Why is it so Difficult?
Let’s face it, clinical trial enrollment is not a simple process. Patients can be difficult to find, and site feasibility is just one of the many aspects that need to be considered. Companies also need an efficient method to conduct therapeutic area or program feasibility, as well as protocol feasibility. The Feasibility Focus Matrix below describes each type of clinical trial feasibility.
As you can see from the graphic above, the key is data analytics. Without investigator data or a complete picture of feasibility data, it becomes just a guessing game. You will run into the same challenges over and over. Sites are chosen:
- Despite poor performance (or lack of data to understand their performance)
- Based on relationships with the CRO or pharma company
- Because they are viewed as a key opinion leader
- Based on an incomplete or non-existent feasibility process
Pharma companies need to find a way to utilize industry data:
- To understand the complete picture of potential investigators
- To understand if sites are participating in similar trials that might cause enrollment competition
- To evaluate sites based on protocol inclusion/exclusion criteria
Data Factors to Consider
For domestic and global studies, both large and small, a careful, data driven evaluation and selection of investigative sites is crucial for the successful completion of a trial on time, within budget, and with high quality data.
The clinical trial site selection process needs to consider several data-driven factors.
For site feasibility, these data-driven factors shown above should consider the investigator experience in four main steps:
- Finding the right investigators
- Engaging the right investigators
- Selecting the right investigators
- Efficiently Managing relationships with the right investigators
In my next blog I will discuss these four steps in detail.