By the time you’ve identified a compound and are ready to verify the effectiveness of a targeted indication, literally millions of dollars are at stake, so you can’t afford to take unnecessary risks with costs or timelines.
What criteria can you apply to the site feasibility process to ensure that you succeed? And in what ways are emerging trends in the space rewriting the old rules? Let’s dig in to find out.
five key criteria for determining site feasibility
It’s essential to understand not only what your proposed sites can do, but also what they actually have done in the past. Consequently, here are five essential questions you should ask for insights into site feasibility:
- Has the site successfully conducted clinical trials in the past?
- Was the site able to recruit the specific patient population we are seeking?
- Does the site have a sufficient population of patients who meet our inclusion criteria?
- Does the site have adequate staff, and are they properly trained, to conduct the trial?
- Will the site be participating in any competing studies — that is, will another study make use of the same patient population or target the same indication — at the time of our clinical trial?
Let’s turn to look at a couple of emerging trends in the life sciences space that make getting the right answers to questions like these more important than ever.
key trends in site feasibility
Site feasibility, like so much else in the life sciences space, is undergoing a period of rapid change. What emerging trends should be top of mind?
well-managed data collection and storage systems are differentiators
As you know, sites that have well-managed systems in place for the collection and storage of data are going to have a significant leg up in the future. In fact, it might be more accurate to say that they already do today.
But why, exactly, is that the case?
Three differentiators come to mind:
- It means they can spend less time answering questionnaires.
- It helps them present a more complete picture of their site as an experience.
- It enables them to quickly and accurately identify inefficiencies in existing processes.
On the sponsor's end, what’s more, these data management best practices can streamline partnerships — even with sites they’ve worked with in the past — by eliminating redundant questions early in the site feasibility process.
All of this is part and parcel of broader shifts enabled by digital transformation. As new communication channels make it easier to collect questionnaires or communicate with principal investigators, for example, that in turn expedites the process of vetting potential sites.
recruiting diverse patient populations may lead to strategic shifts
Recruiting diverse patient populations for clinical trials is among the top priorities for life sciences leaders across the board today. And that isn’t going to change. Looking ahead, rather, it should be built into your site feasibility strategy from the jump.
Obviously, this has important implications for site feasibility, particularly in light of evolving technologies in the field. A few key questions to consider include:
- Do you have an established network of clinical trial sites in underserved communities? Don’t overlook “non-traditional” sites like community health centers and pharmacies.
- Are working with racially and ethnically diverse principal investigators (PIs) and staff members? Remember, your team should reflect the makeup of the communities they’re serving — otherwise, issues of unconscious or implicit bias could come into play.
- In order to recruit more diverse patient populations, is it possible to target patients who live farther away, provided that the follow-up parts of the trial can be carried out remotely?
From the standpoint of site feasibility, how your organization answers questions like these could mean the difference between failure and success.
When you’re ready to start evaluating site feasibility, Randstad Life Sciences can deliver value in so many ways, for example:
- identifying the best sites
- developing, disseminating and evaluating site feasibility surveys
- conducting site qualification visits with local CRAs to improve speed and reduce costs
- comprehensively staffing the sites with experienced resources (if needed) in order to allow naive investigators to participate
Perhaps most importantly, we have the depth of experience to ensure you get it right the first time, without unnecessary delays dragging out the process — or compromising your clinical trial altogether. For example, beyond ensuring you have the right personnel with the proper training and experience, we can also provide study coordinators to help staff the sites, with proven resources if needed, to allow naive investigators with access to the desired patient population to participate.
Of course, that’s just one example of the ways we can deliver value to pharmaceutical and life sciences companies. Get in touch with us today to find out more.