Preparing for Success: A Better Way to Manage the Feasibility Process
The site selection and feasibility process is really quite straightforward on paper. And yet it is astonishingly hard. Here are some numbers that prove the point:
- 11 percent of sites selected never enroll a single patient;
- Sponsors’ original timelines end up doubling to meet the desired goals (and nearly 80 percent of clinical trials fail to meet their timelines);
- Operational costs of running a trial are an estimated $37,000 per day.
What these numbers tell us is that we’re simply not doing enough to get the right sites involved in the right trial.
Using a standard maturity model, we can evaluate our current status and identify what variables we need to focus on to achieve the desired result. For site feasibility evaluation, there are six variables to examine: data, process, technology, expertise, focus and engagement.
1. Data: to illuminate insights
The industry has no shortage of data. That is, quite literally, what our industry is about. But we don’t take full advantage of its power or even use it correctly in many cases. Folklorist Andrew Lang captured the perils of this quite well: “He uses statistics as a drunken man uses lampposts — for support rather than illumination.” Many businesses, even in our data-driven industry, use data to support their decisions instead of to drive their actions.
But data are really only valuable if you can translate them into actionable insights. And to do that, you must understand them.
2. Process: an account management feasibility approach
We can all agree that the current start-up process sponsors and CROs follow is flawed.
Each study is treated as an entirely new engagement, which creates unnecessary work and frustrates sites. Here’s just a small sample of common site complaints:
- “I keep doing studies for a handful of sponsors; I need to expand my reach. How do I get on other sponsors’ lists?”
- “Every time I engage with a new study, even for an existing sponsor, it’s like I’m working with a new team — the rules and processes keep changing.”
- “Last month, I updated my FDA 1572 with new contact information and associated regulatory documents — don’t you have that?”
One alternative to this cumbersome process is to use an account management approach to site identification, breaking the process down to four steps:
- Design a library of questionnaire templates and a list of investigators;
- Build deep site relationships and treat them like customers;
- Convert quickly and effectively; and
- Activate sooner.
3. Technology for speed and automation
We’re entering the second decade of the 21st century. Site feasibility cannot be a manual or analog process. It demands sophisticated technology and, just as important, the right technology.
As with data, the industry has plenty of technology. What we need is technology that allows study teams to find and qualify the best set of investigators for a given trial. This boils down to the speed and automation of feasibility. It can be broken down into three areas:
- Visibility and transparency throughout the process, including ease of tracking responders and non-responders;
- Automation: follow-up thresholds and ranking of sites based on scoring algorithms; and
- Simple and easy: pre-population of responses based on previously submitted surveys.
4. Expertise: an art and a science
There’s a tremendous amount of data and information that is getting funneled to our teams to help them with site identification, but who makes sense of it all? Expertise is the art of taking data from disparate sources and turning it into insights, and the science of using that expertise in developing better outcomes more quickly, efficiently and effectively.
When manually conducting site feasibility, there’s no transparency to the various stakeholders throughout the organization as to how the sites have actually responded.
In many cases, there are times when a site will provide an estimated number of patients it could contribute, but by the time the decisions are made as to whether that site should participate in the study or not, the numbers are pretty far off from the original timeline. In this example, you could ascertain that if the sites received an email with no prior notification from the study field team, they will either ignore it or the communication will go to their junk mail, or perhaps even be deleted.
But what if the study field teams let the sites know the feasibility questionnaire was coming and that the sponsor was interested in their participation in the upcoming study? With this strategy, there is a higher likelihood of response — in some cases a 73 percent increase in response.
During site selection and feasibility, there are at least a thousand tasks and activities that must be done concurrently. Success demands intense focus on everything from picking the best set of investigators to getting them to convert to your study as quickly as possible.
Feasibility cannot be just another item to check off on a task list, and it most certainly cannot be left to chance.
6. Engagement: building and sustaining relationships
If I had to choose one of these six variables as the most important, it would be this. It’s all about relationship building. The one-off transactional approach to feasibility no longer works — if it ever did.
When we talk about engagement and relationships, we’re talking about networking and building trust. Networking allows you to share knowledge and ideas, to provide opportunities and connections. Trust, of course, is an incredibly valuable business commodity and a reputational asset.
Engagement and relationships create results.
When you take the time to build genuine relationships with your sites, you get to know what they truly want and need from you. You gain knowledge and context, not just information. From there, it becomes possible to set goals and define expectations going forward. That can be something as simple as a pre-call to the sites that you’re interested in to give them a heads-up on your study rather than shooting off an email. When we pick up the phone to talk to potential investigators, we have an opportunity to discuss the really exciting portion of that study.
In a maturity model, once you assess the six variables, you plot your current and desired states and compare them to industry averages.
And that’s the roadmap to success. If this approach is used correctly, there are several expected, promising results:
- Quick identification of high-performing investigators built intelligently via data and relationships;
- Rapid responses to site feasibility questionnaires due to shortened surveys, leveraging relationships and better planning; and
- Optimized processes that sponsors and CROs can deploy across all studies in their portfolio, not just one-by-one.